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Imai H, Kawasaki M, Yoshida A, Kanamori H, Okura H. Differences in vascular tissue response after stent implantation between biolimus-eluting and everolimus-eluting stents: a sub-study of the NEXT study. Heart Vessels 2025; 40:285-294. [PMID: 39379621 DOI: 10.1007/s00380-024-02467-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/30/2023] [Accepted: 09/25/2024] [Indexed: 10/10/2024]
Abstract
NEXT [NOBORI biolimus-eluting stent (BES) versus XIENCE/PROMUS everolimus-eluting stent (EES) trial] was a multicenter, randomized, prospective trial that included 3235 patients with 8-12 months of follow-up imaging at 18 centers. IB-IVUS images were analyzed at an interval of 0.5 mm using a motorized pull-back system in each plaque that required stent implantation. We analyzed seven cross-sections at the site of minimal lumen area and ten cross-sections in proximal and distal peripheral sites prior to the procedure, after stent implantation and after 8 months. We averaged the relative blue volume, relative green volume, relative yellow volume, and relative red volume across seven cross-sections using the manufacturer's default setting. Fifty-four lesions in 50 patients were analyzed. There were 28 lesions in 25 patients in the EES group and 26 lesions in 25 patients in the BES group. The patient characteristics did not differ significantly between the two groups except high-density lipoprotein cholesterol. There were no significant differences before and after stent implantation after 8 months in relative red volume, relative yellow volume, relative green volume or relative blue volume. Although the present study was likely underpowered for statistical analyses and larger populations are needed to confirm the conclusions, the vascular response regarding tissue characterization was similar between EES and BES, even though the thickness and releasing materials differed between the stents.
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Affiliation(s)
- Hajime Imai
- Department of Cardiology, Gifu University Graduate School of Medicine, Gifu, Japan
| | - Masanori Kawasaki
- Department of Cardiology, Gifu Heart Center, 4-14-4 Yabuta-Minami, Gifu, 500-8384, Japan.
| | - Akihiro Yoshida
- Department of Cardiology, Gifu University Graduate School of Medicine, Gifu, Japan
| | - Hiromitsu Kanamori
- Department of Cardiology, Gifu University Graduate School of Medicine, Gifu, Japan
| | - Hiroyuki Okura
- Department of Cardiology, Gifu University Graduate School of Medicine, Gifu, Japan
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2
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Gurgoglione FL, Donelli D, Antonelli M, Vignali L, Benatti G, Solinas E, Tadonio I, Magnani G, Denegri A, Lazzeroni D, Montone RA, Bonadonna RC, Nicolini F, Ardissino D, Niccoli G. Polymer-free stents for percutaneous coronary intervention in diabetic patients: a systematic review and meta-analysis. Future Cardiol 2024; 20:485-497. [PMID: 38980301 PMCID: PMC11485834 DOI: 10.1080/14796678.2024.2370688] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2024] [Accepted: 06/18/2024] [Indexed: 07/10/2024] Open
Abstract
Aim: To compare the efficacy of polymer-free drug-eluting stents (PF-DES) versus other stents in diabetic patients with coronary artery disease undergoing percutaneous coronary interventions.Materials & methods: A systematic review and meta-analysis were performed to identify pertinent randomized controlled trials. The primary end point was the occurrence of target lesion failure.Results: Eight randomized controlled trials were included for a total of 4854 subjects. The PF-DES group experienced a trend in favor of a lower rate of target lesion failure (Incidence rate ratio = 0.91; p = 0.11) and a significantly lower rate of cardiac mortality, as compared with the control group (Incidence rate ratio = 0.82; p = 0.04). However, statistical significance was lost if bare-metal stent patients were excluded and a trend in favor of the PF-DES strategy was reported only for cardiac mortality.Conclusion: PF-DES could be a valuable strategy in diabetic patients with coronary artery disease undergoing percutaneous coronary interventions.
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Affiliation(s)
| | - Davide Donelli
- Division of Cardiology, University of Parma, Parma University Hospital, Parma, Italy
| | - Michele Antonelli
- Department of Public Health, AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
| | - Luigi Vignali
- Division of Cardiology, Parma University Hospital, Parma, Italy
| | - Giorgio Benatti
- Division of Cardiology, Parma University Hospital, Parma, Italy
| | - Emilia Solinas
- Division of Cardiology, Parma University Hospital, Parma, Italy
| | - Iacopo Tadonio
- Division of Cardiology, Parma University Hospital, Parma, Italy
| | - Giulia Magnani
- Division of Cardiology, Parma University Hospital, Parma, Italy
| | - Andrea Denegri
- Division of Cardiology, Parma University Hospital, Parma, Italy
| | | | - Rocco Antonio Montone
- Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
| | - Riccardo C Bonadonna
- Division of Endocrinology & Metabolic Diseases, University of Parma, Parma, Italy
| | - Francesco Nicolini
- Division of Cardiac-surgery, University of Parma, Parma University Hospital, Parma, Italy
| | - Diego Ardissino
- Division of Cardiology, University of Parma, Parma University Hospital, Parma, Italy
| | - Giampaolo Niccoli
- Division of Cardiology, University of Parma, Parma University Hospital, Parma, Italy
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3
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Patel KP, Lansky AJ, Kelbæk H, Xu B, van Royen N, Johnson TW, Anderson R, Wijns W, Baumbach A. Long-Term Percutaneous Coronary Intervention Outcomes in Chronic Versus Acute Coronary Syndromes (TARGET All Comers Trial). Am J Cardiol 2024; 217:94-101. [PMID: 38350507 DOI: 10.1016/j.amjcard.2023.12.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2023] [Revised: 11/20/2023] [Accepted: 12/08/2023] [Indexed: 02/15/2024]
Abstract
In the Targeted therapy with a localised abluminal coated, low-dose sirolimus-eluting, biodegreadable polymer coronary stent (TARGET; NCT02520180) All Comers trial the biodegradable polymer (BP) sirolimus-eluting FIREHAWK stent was noninferior to the durable polymer (DP) everolimus-eluting XIENCE stent with respect to target lesion failure (TLF) at 1 and 5 years; however, the long-term safety and efficacy in the setting of acute coronary syndromes (ACS) are not known. We sought to assess the long-term outcomes in ACS versus chronic coronary syndromes (CCS) with BP sirolimus-eluting stent (SES) versus DP everolimus-eluting stent (EES). The TARGET AC study was a multicenter, open-label, noninferiority trial of all comer patients randomly allocated 1:1 to BP SES or DP EES (stratified by ST-elevation myocardial infarction and study site). In this predefined substudy, the outcomes were compared based on clinical presentation (ACS vs CCS) and treatment allocation. A total of 1,653 patients were enrolled (728 with ACS and 922 with CCS), with 94% completing the 5-year follow-up. The baseline characteristics were well-matched between the 2 stent types; however, co-morbidities were more prevalent in the CCS than in the ACS population. TLF (15.5% vs 17.7%, p = 0.24), patient-oriented outcomes (32.0% vs 34.4%, p = 0.31), and stent thrombosis (4.1% vs 3.3%, p = 0.40) were similar between patients with ACS and patients with CCS. In the ACS cohort, the outcomes at 5 years for BP SES versus DP EES were similar for TLF (16.0% vs 14.9%, p = 0.70), ischemia-driven target lesion revascularization (5.6% vs 8.3%, p = 0.17), and definite/probable stent thrombosis (2.7% vs 4.6%, p = 0.18). The same was true for the CCS cohort, with 5-year outcomes for BP SES versus DP EES for TLF (18.0% vs 17.4%, p = 0.82), ischemia-driven target lesion revascularization (6.4% vs 5.0%, p = 0.37), and definite/probable stent thrombosis (3.0% vs 1.8%, p = 0.26). In conclusion, in the TARGET AC trial, 1 in 3 patients had a major adverse event at 5 years, irrespective of CCS or ACS presentation. Long-term, the BP sirolimus-eluting FIREHAWK stent was as safe and effective as the DP everolimus-eluting XIENCE stent across the spectrum of clinical presentations.
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Affiliation(s)
- Kush P Patel
- Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom
| | - Alexandra J Lansky
- Division of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Henning Kelbæk
- Department of Cardiology, Zealand University Hospital, Roskilde, Denmark
| | - Bo Xu
- Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; Peking Union Medical College, Beijing, China
| | - Niels van Royen
- Department of Cardiology, Radbound University, Nijmegen, the Netherlands
| | - Thomas W Johnson
- Bristol Heart Institute, University of Bristol, Bristol, United Kingdom; University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom
| | - Richard Anderson
- Department of Cardiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom
| | - William Wijns
- The Lambe Institute for Translational Medicine and Curam, University of Galway, Galway, Ireland
| | - Andreas Baumbach
- Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom.
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Avanzas P, de la Torre JM. Seeking precision in percutaneous coronary revascularization: The best stent for each setting. Int J Cardiol 2023; 389:131222. [PMID: 37527755 DOI: 10.1016/j.ijcard.2023.131222] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2023] [Accepted: 05/17/2023] [Indexed: 08/03/2023]
Affiliation(s)
- Pablo Avanzas
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, ISPA, Oviedo, Spain; Departamento de Medicina, Universidad de Oviedo, Oviedo, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.
| | - José María de la Torre
- Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Santander, Spain; Instituto de Investigación Valdecilla (IDIVAL), Santander, Spain.
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Natsuaki M, Watanabe H, Morimoto T, Kozuma K, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Hanaoka KI, Tanabe K, Morino Y, Ishikawa T, Katoh H, Nishikawa H, Tamura T, Ono K, Yamamoto K, Ishihara T, Abe M, Taniguchi R, Ikari Y, Okada K, Kimura T. Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial. EUROINTERVENTION 2023; 19:e402-e413. [PMID: 37395475 PMCID: PMC10397680 DOI: 10.4244/eij-d-23-00076] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/29/2023] [Accepted: 05/30/2023] [Indexed: 07/04/2023]
Abstract
BACKGROUND There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years. AIMS We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. METHODS The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES. RESULTS From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. CONCLUSIONS The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.
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Affiliation(s)
| | | | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
| | - Ken Kozuma
- Department of Cardiology, Teikyo University Hospital, Tokyo, Japan
| | - Kazushige Kadota
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
| | | | - Yoshihisa Nakagawa
- Department of Cardiology, Shiga University of Medical Science Hospital, Otsu, Japan
| | - Takashi Akasaka
- Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan
| | | | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Yoshihiro Morino
- Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan
| | - Tetsuya Ishikawa
- Division of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan
| | - Harumi Katoh
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
| | | | | | - Koh Ono
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Ko Yamamoto
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | | | - Mitsuru Abe
- Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
| | - Ryoji Taniguchi
- Division of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan
| | - Yuji Ikari
- Division of Cardiology, Tokai University Hospital, Isehara, Japan
| | - Kozo Okada
- Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
| | - Takeshi Kimura
- Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan
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Mohamad T, Jyotsna F, Farooq U, Fatima A, Kar I, Khuwaja S, Memon UA, Kumari V, Puri P, Aslam ZM, Elder Z, Varrassi G, Paladini A, Khatri M, Kumar S, Muzammil MA. Individualizing Medicinal Therapy Post Heart Stent Implantation: Tailoring for Patient Factors. Cureus 2023; 15:e43977. [PMID: 37746355 PMCID: PMC10516147 DOI: 10.7759/cureus.43977] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2023] [Accepted: 08/23/2023] [Indexed: 09/26/2023] Open
Abstract
The field of cardiovascular medicine is undergoing a transformative shift towards personalized medicinal therapy, particularly in the context of post stent implantation. This narrative review explores the significance, challenges, and future directions of individualized treatment strategies for patients with coronary stents. The review highlights the pivotal role of personalized approaches in optimizing treatment efficacy and minimizing adverse events. Real-world clinical studies and trials underscore the importance of tailoring antiplatelet therapy based on platelet function testing, genetic testing, and risk scoring. These studies reveal that personalized medicinal treatment improves clinical outcomes by balancing preventing thrombotic events and mitigating bleeding risks. Challenges, including cost, test availability, patient adherence, and ethical considerations, are discussed in depth, shedding light on the complexities of implementing personalized approaches. Technological advancements, including omics data integration, artificial intelligence, and big data analytics, shape the future of personalized medicinal therapy. These tools enable precise pharmacogenomic selection of medications and the development of integrated risk-scoring systems. Patient engagement and education are also central, with empowered patients and remote monitoring contributing to collaborative decision-making. In conclusion, the narrative review underscores that personalized medicinal therapy post stent implantation holds immense promise for revolutionizing cardiovascular care. By embracing a comprehensive approach that considers genetics, clinical factors, and patient preferences, healthcare providers can optimize treatment outcomes and improve patient quality of life. The evolving landscape of personalized medicine offers a glimpse into a future where tailored treatment strategies become the cornerstone of precision cardiovascular care.
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Affiliation(s)
| | - Fnu Jyotsna
- Medicine, Dr. B.R. Ambedkar State Institute of Medical Sciences, Mohali, IND
| | - Umer Farooq
- Medicine, CMH (Combined Military Hospital) Lahore Medical College and Institute of Dentistry, Lahore, PAK
| | - Aroob Fatima
- Medicine, Ejaz Sikandar Memorial Hospital, Kanganpur, PAK
| | - Indrani Kar
- Medicine, Lady Hardinge Medical College, New Delhi, IND
| | - Sundal Khuwaja
- Medicine, Liaquat University of Medical and Health Sciences, Jamshoro, PAK
| | - Unaib Ahmed Memon
- Internal Medicine, Liaquat University of Medical and Health Sciences, Jamshoro, PAK
| | - Versha Kumari
- Medicine, Liaquat University of Medical and Health Sciences, Jamshoro, PAK
| | - Piyush Puri
- Medicine, Adesh Institute of Medical Science and Research, Bathinda, IND
| | - Zaid M Aslam
- Internal Medicine, Ziauddin University, Karachi, PAK
| | - Zachary Elder
- Medical Education, American University of the Caribbean School of Medicine, Cupecoy, SXM
| | | | - Antonella Paladini
- Department of MESVA (Life, Health, and Environmental Sciences), University of L'Aquila, L'Aquila, ITA
| | - Mahima Khatri
- Medicine and Surgery, Dow University of Health Sciences, Karachi, PAK
| | - Satesh Kumar
- Medicine and Surgery, Shaheed Mohtarma Benazir Bhutto Medical College, Karachi, PAK
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Khatri M, Kumar S, Mahfooz K, Sugandh F, Dembra D, Mehak F, Rachna Panjwani GA, Islam H, Islam R, Ibn E Ali Jaffari SM, Patel T, Kumar A, Kumar N, Varrassi G. Clinical Outcomes of Polymer-Free Versus Polymer-Coated Drug-Eluting Stents in Patients With Coronary Artery Disease: A Systematic Review and Meta-Analysis. Cureus 2023; 15:e38215. [PMID: 37252538 PMCID: PMC10224769 DOI: 10.7759/cureus.38215] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/10/2023] [Accepted: 04/27/2023] [Indexed: 05/31/2023] Open
Abstract
Drug-eluting stents have transformed the treatment of coronary artery disease (CAD), and there are two types: polymer-free and polymer-coated stents. Polymer-free stents have a coating that is quickly absorbed by the body, whereas polymer-coated stents have a coating that remains on the stent surface. This meta-analysis and systematic review aimed to compare the clinical outcomes of these two stent types in patients with coronary artery disease. The literature and abstracts from significant databases were reviewed to compare polymer-free drug-eluting stents (PF-DES) and polymer-coated drug-eluting stents (PC-DES) for the treatment of coronary artery disease (CAD). The primary efficacy endpoints of the study were all-cause mortality and deaths from cardiovascular and non-cardiovascular causes. Among the secondary outcomes were incidences of myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, stroke, and major adverse cardiovascular events (MACEs). In terms of the primary outcomes, the combined analysis revealed a marginally lower risk of all-cause mortality (relative risk, RR (95% CI) = 0.92 (0.85, 1.00), p = 0.05, I2 = 0%) with the use of PF-DES versus PC-DES. Nonetheless, there was no significant difference in cardiovascular mortality (RR (95% CI) = 0.97 (0.87, 1.08)) or non-cardiovascular mortality (RR (95% CI) = 0.87 (0.69, 1.10), p = 0.25, I2 = 9%) between the groups. Furthermore, univariate meta-regression revealed that male gender and prior myocardial infarction were independently associated with an increased risk of all-cause mortality and cardiovascular disease. According to the current meta-analysis, no statistically significant differences existed in PF-DES and PC-DES outcomes. More extensive research is needed to investigate these findings further and establish their validity.
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Affiliation(s)
- Mahima Khatri
- Medicine and Surgery, Dow University of Health Sciences, Karachi, PAK
| | - Satesh Kumar
- Medicine and Surgery, Shaheed Mohtarma Benazir Bhutto Medical College, Karachi, PAK
| | - Kamran Mahfooz
- Internal Medicine, New York Health and Hospital Corporation, Lincoln Medical Center, New York, USA
| | - Fnu Sugandh
- Medicine, Ghulam Muhammad Mahar Medical College, Sukkur, PAK
- Medicine, Civil Hospital Karachi, Sukkur, PAK
| | - Deepak Dembra
- Medicine, Ghulam Muhammad Mahar Medical College, Sukkur, PAK
| | - Fnu Mehak
- Surgery, Ghulam Muhammad Mahar Medical College, Sukkur, PAK
| | | | - Hamza Islam
- Research, Punjab Medical College, Faisalabad, PAK
| | - Rabia Islam
- Research, Faisalabad Medical University, Faisalabad, PAK
| | | | - Tirath Patel
- Surgery, American University of Antigua, St. John, ATG
| | - Ajay Kumar
- Internal Medicine, MedStar Union Memorial Hospital, Baltimore, USA
| | - Nomesh Kumar
- Surgery, Detroit Medical Center-Wayne State University of Sinai Grace, Michigan, USA
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Ohya M, Kohsaka S, Kumamaru H, Ikuta A, Nakano J, Shimamoto T, Watanabe Y, Shimamura K, Maeda K, Komiya T, Fuku Y, Kadota K. Modified percutaneous coronary intervention-derived risk models (PARIS and CREDO-Kyoto integer scoring systems) applied to Japanese transcatheter aortic valve replacement patients. Open Heart 2023; 10:openhrt-2022-002172. [PMID: 36657943 PMCID: PMC9853247 DOI: 10.1136/openhrt-2022-002172] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/11/2022] [Accepted: 01/04/2023] [Indexed: 01/20/2023] Open
Abstract
OBJECTIVE Postprocedural ischaemic and bleeding risks after transcatheter aortic valve replacement (TAVR) remain a major concern. Nevertheless, no reliable risk models incorporating both possibilities are currently available. We aimed to assess the accuracy of percutaneous coronary intervention (PCI)-derived models and the performance of a recalibrated model that included variables more applicable to TAVR. METHODS This study included 26 869 patients who had been enrolled in a national registry. Ischaemic events were defined as myocardial infarction, stroke, transient ischaemic attack or peripheral embolism at 1 year. Bleeding events were defined as any bleeding based on the Valve Academic Research Consortium-2 consensus document at 1 year. Patterns of Non-adherence to Anti-Platelet Regimen in Stented Patients (PARIS) and Coronary Revascularisation Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) integer scoring systems were tested. The models were recalibrated by applying new variables using the Fine and Gray method. RESULTS The 1-year cumulative incidences for ischaemic and bleeding events were 2.7% and 3.1%. Patients with high PARIS and CREDO-Kyoto risk scores had higher incidences of both ischaemic (3.3% vs 2.4% vs 2.4%, p<0.001 and 2.8% vs 2.0% vs 0.8%, p<0.001) and bleeding events (3.3% vs 2.5% vs 0.8%, p<0.001 and 3.7% vs 3.0% vs 2.4%, p<0.001) when compared with intermediate and low-risk patients. The receiver operating characteristic area under the curves for these models were 0.53, 0.58, 0.56 and 0.55, respectively. After the models were recalibrated to incorporate variables more applicable to TAVR, the performance of ischaemic and bleeding models modestly improved (0.58 and 0.61, respectively). CONCLUSIONS The PCI-derived models demonstrated modest accuracy but was inadequate for risk stratification of TAVR patients at 1-year follow-up. TRIAL REGISTRATION NUMBER 3395.
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Affiliation(s)
- Masanobu Ohya
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan
| | - Shun Kohsaka
- Department of Cardiology, Keio University, Tokyo, Japan
| | - Hiraku Kumamaru
- Department of Clinical Epidermiology, Tokyo University, Tokyo, Japan
| | - Akihiro Ikuta
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan
| | - Jota Nakano
- Department of Cardiovascular Surgery, Kurashiki Central Hospital, Kurashiki, Japan
| | - Takeshi Shimamoto
- Department of Cardiovascular Surgery, Hamamatsu Rosai Hospital, Shizuoka, Japan
| | | | | | - Koichi Maeda
- Department of Cardiology, Osaka University, Osaka, Japan
| | - Tatsuhiko Komiya
- Department of Cardiovascular Surgery, Kurashiki Central Hospital, Kurashiki, Japan
| | - Yasushi Fuku
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan
| | - Kazushige Kadota
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan
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9
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Bibi S, Khan A, Khan AH, Khan MN, Mushtaq S, Rashid SA. Primary percutaneous coronary intervention in CAD patients: A comparison of major adverse cardiovascular events of second- and third-generation drug-eluting stents. Front Pharmacol 2022; 13:900798. [PMID: 36467026 PMCID: PMC9709248 DOI: 10.3389/fphar.2022.900798] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2022] [Accepted: 10/21/2022] [Indexed: 08/30/2023] Open
Abstract
Background: Biodegradable polymer (BP) drug-eluting stents (DES) have been introduced as a novel solution to the problems of durable polymer (DP) stents. In Pakistan, very few studies are available for the treatment intervention in post-primary percutaneous coronary intervention (PPCI) patients. Our study will compare the major adverse cardiovascular events (MACEs) and their predictors in patients with coronary artery disease (CAD) undergoing PPCI with second- or third-generation DES. Methodology: An observational, retrospective, cohort study was carried out on CAD patients undergoing PPCI with either second- (DP-XIENCE Prime/XIENCE Xpedition) or third-generation (BP-BioMatrix NeoFlex/BioMatrix Alpha) DES. MACEs were assessed after 1 year of PPCI procedure in 341 patients and screened as per inclusion/exclusion criteria (167 in the second-generation group and 174 in the third-generation group). Results: The number of male patients (86.2%) was more than female patients in our study population. MACEs were reported in 4.19% patients after 1 year duration, and the percentage of MACEs was more in the second-generation DES group (4.77%) than in the third-generation group (3.44%); however, statistical analysis has not found any significant difference (p = 0.534). The rate of myocardial infarction (1.19% vs. 0.57%) and stent thrombosis (1.8% vs. 1.15%) was more in the second-generation DES group. However, restenosis (1.19% vs. 1.15%) and cardiac death (0.59% vs. 0.57%) were almost same in both groups. A significant association was found between MACEs and diabetes mellitus (p = 0.025), hypertension (p = 0.035), smoking (p = 0.008), and a family history of CAD (p = 0.018). Conclusion: BP-BioMatrix and DP-XIENCE DES have comparable clinical outcomes. Findings of the current study will assist the policy makers and healthcare providers in the rationalization of scarce resources and evidence-based patient care. However, longer follow-up studies are required for convincing results.
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Affiliation(s)
- Salma Bibi
- Department of Pharmacy, Quaid-i-Azam University, Islamabad, Pakistan
| | - Amjad Khan
- Department of Pharmacy, Quaid-i-Azam University, Islamabad, Pakistan
| | - Amer Hayat Khan
- Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, George Town, Penang, Malaysia
| | - Muhammad Niaz Khan
- Department of Interventional Cardiology, Hayatabad Medical Complex, Peshawar, Pakistan
| | - Saima Mushtaq
- Department of Healthcare Biotechnology, Atta-ur-Rahman School of Applied Biosciences, National University of Sciences and Technology, Islamabad, Pakistan
| | - Sheikh Abdur Rashid
- Gomal Center of Pharmaceutical Sciences, Faculty of Pharmacy, Gomal University, D.I.Khan, Pakistan
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10
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Yuan H, Wu Z, Lu T, Wei T, Zeng Y, Liu Y, Huang C. Comparison of biodegradable and durable polymer drug-eluting stents in acute coronary syndrome: a meta-analysis. BMJ Open 2022; 12:e058075. [PMID: 35676012 PMCID: PMC9185674 DOI: 10.1136/bmjopen-2021-058075] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/28/2022] Open
Abstract
OBJECTIVE To compare the safety and effectiveness between biodegradable polymer drug-eluting stents (BP-DES) and durable polymer drug-eluting stents (DP-DES) in patients with acute coronary syndrome (ACS). DESIGN Meta-analysis of randomised controlled trials (RCTs). PRIMARY AND SECONDARY OUTCOME MEASURES Major adverse cardiovascular events (MACEs) were considered the primary endpoint. Efficacy endpoints included target vessel revascularisation (TVR) and target lesion revascularisation (TLR). Safety endpoints included all-cause death, cardiac death, target vessel myocardial infarction and stent thrombosis (ST). METHODS We searched PubMed, Medline, Embase and the Cochrane Controlled Register of Trials for comparative studies of BP-DES and DP-DES in patients with ACS from January 2000 to July 2021. Statistical pooling was performed to estimate incidence using a random-effects model with generic inverse-variance weighting. Risk estimates were computed with 95% CIs. RESULTS Eight articles with seven RCTs that compared BP-DES and DP-DES in patients with ACS were identified and included in the qualitative and quantitative analyses. There was no difference in the baseline characteristics, except for the number of smoking patients (OR: 1.13, 95% CI 1.03 to 1.24; p=0.008, I2=29%), which was significantly lower in the BP-DES group. The meta-analysis demonstrated that MACEs, efficacy endpoints and safety endpoints were similar between the groups at 1 year. However, the incidence of total ST was significantly different between the BP-DES and DP-DES groups in the follow-up period (p=0.0001). Further analysis showed a statistically significant difference in MACEs (OR: 0.71, 95% CI 0.57 to 0.88; p=0.002, I2=0 %), TLR (OR: 0.71, 95% CI 0.51 to 1.01; p=0.05, I2=0%), TVR (OR: 0.70, 95% CI 0.52 to 0.94; p=0.002, I2=15%), total ST incidence (OR: 0.59, 95% CI 0.46 to 0.77; p=0.0001, I2=48%) and ST incidence (OR: 0.63, 95% CI 0.47 to 0.85; p=0.002, I2=0%) over 2 years. CONCLUSION This meta-analysis revealed that both stent types demonstrated excellent safety and efficacy profiles at 12 months. However, a slight increase in MACEs, TLR, TVR and ST incidence was observed in the DP-DES group over the 2-year follow-up period, suggesting that BP-DES may be more favourable when treating patients with ACS. TRIAL REGISTRATION NUMBER NCT00389220.
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Affiliation(s)
- Haoyong Yuan
- Department of Cardiovascular Surgery, The second xiangya hospital of Central South University, Changsha, Hunan, China
- Engineering Laboratory of Hunan Province for Cardiovascular Biomaterials, Changsha, Hunan, China
| | - Zhongshi Wu
- Department of Cardiovascular Surgery, The second xiangya hospital of Central South University, Changsha, Hunan, China
- Engineering Laboratory of Hunan Province for Cardiovascular Biomaterials, Changsha, Hunan, China
| | - Ting Lu
- Department of Cardiovascular Surgery, The second xiangya hospital of Central South University, Changsha, Hunan, China
- Engineering Laboratory of Hunan Province for Cardiovascular Biomaterials, Changsha, Hunan, China
| | - Tingting Wei
- Department of Paediatrics, Hunan Provincial Maternal and Child Health Care Hospital, Changsha, Hunan, China
| | - Yifan Zeng
- Department of Cardiovascular Surgery, The second xiangya hospital of Central South University, Changsha, Hunan, China
| | - Yalin Liu
- Department of Cardiovascular Surgery, The second xiangya hospital of Central South University, Changsha, Hunan, China
- Engineering Laboratory of Hunan Province for Cardiovascular Biomaterials, Changsha, Hunan, China
| | - Can Huang
- Department of Cardiovascular Surgery, The second xiangya hospital of Central South University, Changsha, Hunan, China
- Engineering Laboratory of Hunan Province for Cardiovascular Biomaterials, Changsha, Hunan, China
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11
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Mennuni MG, Sagazio E, Patti G. In‐Stent Restenosis in the New Generation DES Era. Interv Cardiol 2022. [DOI: 10.1002/9781119697367.ch21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022] Open
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12
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Delewi R, de Winter RJ. The Biolimus Stent Family. Interv Cardiol 2022. [DOI: 10.1002/9781119697367.ch34] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022] Open
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13
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Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol 2022; 7:407-417. [PMID: 35234821 PMCID: PMC8892373 DOI: 10.1001/jamacardio.2021.5244] [Citation(s) in RCA: 187] [Impact Index Per Article: 62.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/22/2023]
Abstract
IMPORTANCE Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS). OBJECTIVE To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS. DESIGN, SETTING, AND PARTICIPANTS This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021. INTERVENTIONS Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091). MAIN OUTCOMES AND MEASURES The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point. RESULTS Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1- to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, -0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1- to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, -0.63% [95% CI, -1.20% to -0.06%]; HR, 0.46 [95% CI, 0.23-0.94]). CONCLUSIONS AND RELEVANCE In patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials. TRIAL REGISTRATION ClinicalTrials.gov Identifiers: NCT02619760 and NCT03462498.
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Affiliation(s)
- Hirotoshi Watanabe
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
| | | | - Ko Yamamoto
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Yuki Obayashi
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Manabu Ogita
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
| | - Satoru Suwa
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
| | - Tsuyoshi Isawa
- Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan
| | - Takenori Domei
- Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan
| | - Kyohei Yamaji
- Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan
| | - Shojiro Tatsushima
- Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan
| | - Hiroki Watanabe
- Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan
| | - Masanobu Ohya
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Hideo Tokuyama
- Department of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital, Kawaguchi, Japan
| | - Tomohisa Tada
- Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan
| | - Hiroki Sakamoto
- Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan
| | | | | | | | | | - Kiyoshi Hibi
- Department of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
| | - Mitsuru Abe
- Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
| | - Kazuya Kawai
- Department of Cardiology, Chikamori Hospital, Kochi, Japan
| | - Koichi Nakao
- Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan
| | - Kenji Ando
- Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan
| | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Yuji Ikari
- Department of Cardiology, Tokai University Hospital, Isehara, Japan
| | - Yoshihiro Morino
- Department of Cardiology, Iwate Medical University Hospital, Morioka, Japan
| | - Kazushige Kadota
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Yutaka Furukawa
- Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan
| | - Yoshihisa Nakagawa
- Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Japan
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
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14
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Asano T, Ono M, Dai Z, Saito A, Kanie T, Takaoka Y, Mizuno A, Yoneoka D, Komiyama N. Temporal trends in clinical outcomes after percutaneous coronary intervention: a systematic review of 66,327 patients from 25 all-comers trials. EUROINTERVENTION 2022; 17:1318-1329. [PMID: 34602385 PMCID: PMC9743235 DOI: 10.4244/eij-d-21-00192] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
BACKGROUND With the improvements of percutaneous coronary intervention (PCI) technology and post-PCI patient management, several registry studies reported temporal trends in post-PCI clinical outcomes. However, their results are inconclusive, potentially reflecting region-specific trends, based on site-reported events without external validity. AIMS This study aimed to investigate temporal trends in post-PCI clinical outcomes in all-comers randomised controlled trials (RCTs) involving coronary stents. METHODS We performed a systematic review identifying RCTs comparing a clinical outcome as a primary endpoint among different coronary stents with an all-comers design and independent clinical event adjudication, extracting the study start year, patient baseline characteristics, and one- and five-year clinical outcomes. Temporal trends in clinical outcomes (cardiac death, myocardial infarction [MI], target lesion revascularisation [TLR], stent thrombosis [ST]) were assessed using random-effects meta-regression analyses, estimating the relationship between clinical outcomes and study start year. RESULTS Overall, 25 all-comers trials (51 device arms, 66,327 patients) conducted between 2003 and 2018 fulfilled the eligibility criteria. Random-effects meta-regression analysis revealed significant decreasing trends in one- and five-year cardiac death, one-year TLR, and five-year ST incidences (relative risk per 10-year increase: 0.69 [0.51-0.92], 0.66 [0.44-0.98], 0.60 [0.41-0.88], and 0.18 [0.07-0.44], respectively). There was no significant trend in myocardial infarction incidences. CONCLUSIONS This is the first attempt to clarify and quantify the temporal trends of post-PCI outcome incidence. The 15-year improvements in PCI therapy and post-therapeutic patient management are associated with reduced incidences of cardiac death and PCI-related adverse events.
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Affiliation(s)
- Taku Asano
- Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan
| | - Masafumi Ono
- Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan.,Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.,Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Zhehao Dai
- Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Akira Saito
- Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan
| | - Takayoshi Kanie
- Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan
| | - Yoshimitsu Takaoka
- Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan
| | - Atsushi Mizuno
- Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan.,The Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia, PA, USA.,Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.,Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA
| | - Daisuke Yoneoka
- Division of Biostatistics and Bioinformatics, Graduate School of Public Health, St. Luke's International University, Tokyo, Japan
| | - Nobuyuki Komiyama
- Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan
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15
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Nakamura M, Yaku H, Ako J, Arai H, Asai T, Chikamori T, Daida H, Doi K, Fukui T, Ito T, Kadota K, Kobayashi J, Komiya T, Kozuma K, Nakagawa Y, Nakao K, Niinami H, Ohno T, Ozaki Y, Sata M, Takanashi S, Takemura H, Ueno T, Yasuda S, Yokoyama H, Fujita T, Kasai T, Kohsaka S, Kubo T, Manabe S, Matsumoto N, Miyagawa S, Mizuno T, Motomura N, Numata S, Nakajima H, Oda H, Otake H, Otsuka F, Sasaki KI, Shimada K, Shimokawa T, Shinke T, Suzuki T, Takahashi M, Tanaka N, Tsuneyoshi H, Tojo T, Une D, Wakasa S, Yamaguchi K, Akasaka T, Hirayama A, Kimura K, Kimura T, Matsui Y, Miyazaki S, Okamura Y, Ono M, Shiomi H, Tanemoto K. JCS 2018 Guideline on Revascularization of Stable Coronary Artery Disease. Circ J 2022; 86:477-588. [DOI: 10.1253/circj.cj-20-1282] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Affiliation(s)
- Masato Nakamura
- Division of Cardiovascular Medicine, Toho University Ohashi Medical Center
| | - Hitoshi Yaku
- Department of Cardiovascular Surgery, Kyoto Prefectural University of Medicine
| | - Junya Ako
- Department of Cardiovascular Medicine, Kitasato University Graduate School of Medical Sciences
| | - Hirokuni Arai
- Department of Cardiovascular Surgery, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
| | - Tohru Asai
- Department of Cardiovascular Surgery, Juntendo University Graduate School of Medicine
| | | | - Hiroyuki Daida
- Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine
| | - Kiyoshi Doi
- General and Cardiothoracic Surgery, Gifu University Graduate School of Medicine
| | - Toshihiro Fukui
- Department of Cardiovascular Surgery, Graduate School of Medical Sciences, Kumamoto University
| | - Toshiaki Ito
- Department of Cardiovascular Surgery, Japanese Red Cross Nagoya Daiichi Hospital
| | | | - Junjiro Kobayashi
- Department of Cardiovascular Surgery, National Cerebral and Cardiovascular Center
| | - Tatsuhiko Komiya
- Department of Cardiovascular Surgery, Kurashiki Central Hospital
| | - Ken Kozuma
- Department of Internal Medicine, Teikyo University Faculty of Medicine
| | - Yoshihisa Nakagawa
- Department of Cardiovascular Medicine, Shiga University of Medical Science
| | - Koichi Nakao
- Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center
| | - Hiroshi Niinami
- Department of Cardiovascular Surgery, Tokyo Women’s Medical University
| | - Takayuki Ohno
- Department of Cardiovascular Surgery, Mitsui Memorial Hospital
| | - Yukio Ozaki
- Department of Cardiology, Fujita Health University Hospital
| | - Masataka Sata
- Department of Cardiovascular Medicine, Tokushima University Graduate School of Biomedical Sciences
| | | | - Hirofumi Takemura
- Department of Cardiovascular Surgery, Graduate School of Medical Sciences, Kanazawa University
| | | | - Satoshi Yasuda
- Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
| | - Hitoshi Yokoyama
- Department of Cardiovascular Surgery, Fukushima Medical University
| | - Tomoyuki Fujita
- Department of Cardiovascular Surgery, National Cerebral and Cardiovascular Center
| | - Tokuo Kasai
- Department of Cardiology, Uonuma Institute of Community Medicine, Niigata University Uonuma Kikan Hospital
| | - Shun Kohsaka
- Department of Cardiology, Keio University School of Medicine
| | - Takashi Kubo
- Department of Cardiovascular Medicine, Wakayama Medical University
| | - Susumu Manabe
- Department of Cardiovascular Surgery, Tsuchiura Kyodo General Hospital
| | | | - Shigeru Miyagawa
- Frontier of Regenerative Medicine, Graduate School of Medicine, Osaka University
| | - Tomohiro Mizuno
- Department of Cardiovascular Surgery, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
| | - Noboru Motomura
- Department of Cardiovascular Surgery, Graduate School of Medicine, Toho University
| | - Satoshi Numata
- Department of Cardiovascular Surgery, Kyoto Prefectural University of Medicine
| | - Hiroyuki Nakajima
- Department of Cardiovascular Surgery, Saitama Medical University International Medical Center
| | - Hirotaka Oda
- Department of Cardiology, Niigata City General Hospital
| | - Hiromasa Otake
- Department of Cardiovascular Medicine, Kobe University Graduate School of Medicine
| | - Fumiyuki Otsuka
- Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
| | - Ken-ichiro Sasaki
- Division of Cardiovascular Medicine, Kurume University School of Medicine
| | - Kazunori Shimada
- Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine
| | - Tomoki Shimokawa
- Department of Cardiovascular Surgery, Sakakibara Heart Institute
| | - Toshiro Shinke
- Division of Cardiology, Department of Medicine, Showa University School of Medicine
| | - Tomoaki Suzuki
- Department of Cardiovascular Surgery, Shiga University of Medical Science
| | - Masao Takahashi
- Department of Cardiovascular Surgery, Hiratsuka Kyosai Hospital
| | - Nobuhiro Tanaka
- Department of Cardiology, Tokyo Medical University Hachioji Medical Center
| | | | - Taiki Tojo
- Department of Cardiovascular Medicine, Kitasato University Graduate School of Medical Sciences
| | - Dai Une
- Department of Cardiovascular Surgery, Okayama Medical Center
| | - Satoru Wakasa
- Department of Cardiovascular and Thoracic Surgery, Hokkaido University Graduate School of Medicine
| | - Koji Yamaguchi
- Department of Cardiovascular Medicine, Tokushima University Graduate School of Biomedical Sciences
| | - Takashi Akasaka
- Department of Cardiovascular Medicine, Wakayama Medical University
| | | | - Kazuo Kimura
- Cardiovascular Center, Yokohama City University Medical Center
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
| | - Yoshiro Matsui
- Department of Cardiovascular and Thoracic Surgery, Graduate School of Medicine, Hokkaido University
| | - Shunichi Miyazaki
- Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Kindai University
| | | | - Minoru Ono
- Department of Cardiac Surgery, Graduate School of Medicine, The University of Tokyo
| | - Hiroki Shiomi
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
| | - Kazuo Tanemoto
- Department of Cardiovascular Surgery, Kawasaki Medical School
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16
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Jang AY, Yu J, Oh PC, Kim M, Suh SY, Lee K, Han SH, Kang WC. Real-World Long-Term Clinical Outcomes of Ultrathin Strut Biodegradable Polymer Drug-Eluting Stents in Korean ST-Segment-Elevation Myocardial Infarction (STEMI) Patients with or without Acute Heart Failure Undergoing Primary Percutaneous Coronary Intervention. J Clin Med 2021; 10:jcm10245898. [PMID: 34945194 PMCID: PMC8708844 DOI: 10.3390/jcm10245898] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/24/2021] [Revised: 12/13/2021] [Accepted: 12/14/2021] [Indexed: 11/16/2022] Open
Abstract
Biodegradable polymers (BDPs) and ultrathin struts were recently introduced to drug-eluting stents (DES) to further improve outcomes. In this study, we analyzed and compared the effect of the ultrathin strut BDP-DES (UBDP-DES) with the conventional durable polymer-DES (DP-DES) in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PPCI). A total of 356 STEMI patients (n = 160 in the UBDP-DES group and n = 196 in the DP-DES group) were enrolled. The primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction, and ischemic-driven, target lesion revascularization (ID-TLR). The mean age was 60.3 ± 12.7 years (male 81.7%), and the median follow-up duration was 63.8 months. TLF was numerically more frequent in the UBDP-DES group (8.1% vs. 4.1%; HR 2.14; 95% CI 0.89-5.18; p = 0.091). Propensity score matching (PSM) was performed to balance discrepancies in the baseline characteristics due to patients in the UBDP-DES group initially having more unstable vital signs. However, after PSM (n = 116 in each group), there was no significant difference in TLF (5.3% vs. 5.3%; HR 1.04, 95% CI 0.34-3.22; p = 0.947) or other secondary endpoints including ID-TLR. In the subgroup analysis, subjects with initial acute heart failure (AHF), defined as Killip class ≥ 3, were associated with 13.6% chance of 30-day mortality (9-fold of those without AHF), although chances of repeat revascularization were low (3.0%). Among patients with AHF, the UBDP-DES group was associated with a numerically higher chance of TLF compared with the DP-DES group. There was no difference in TLF between groups in patients without AHF. This study showed that UBDP-DES has long-term clinical outcomes similar to those of conventional DP-DES in real-world Korean STEMI patients receiving PPCI, especially in those without initial AHF.
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Affiliation(s)
- Albert Youngwoo Jang
- Cardiology, Gachon University Gil Medical Center, Incheon 21565, Korea; (A.Y.J.); (P.C.O.); (M.K.); (S.Y.S.); (K.L.); (S.H.H.)
| | - Jongwook Yu
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul 03722, Korea;
| | - Pyung Chun Oh
- Cardiology, Gachon University Gil Medical Center, Incheon 21565, Korea; (A.Y.J.); (P.C.O.); (M.K.); (S.Y.S.); (K.L.); (S.H.H.)
| | - Minsu Kim
- Cardiology, Gachon University Gil Medical Center, Incheon 21565, Korea; (A.Y.J.); (P.C.O.); (M.K.); (S.Y.S.); (K.L.); (S.H.H.)
| | - Soon Yong Suh
- Cardiology, Gachon University Gil Medical Center, Incheon 21565, Korea; (A.Y.J.); (P.C.O.); (M.K.); (S.Y.S.); (K.L.); (S.H.H.)
| | - Kyounghoon Lee
- Cardiology, Gachon University Gil Medical Center, Incheon 21565, Korea; (A.Y.J.); (P.C.O.); (M.K.); (S.Y.S.); (K.L.); (S.H.H.)
| | - Seung Hwan Han
- Cardiology, Gachon University Gil Medical Center, Incheon 21565, Korea; (A.Y.J.); (P.C.O.); (M.K.); (S.Y.S.); (K.L.); (S.H.H.)
| | - Woong Chol Kang
- Cardiology, Gachon University Gil Medical Center, Incheon 21565, Korea; (A.Y.J.); (P.C.O.); (M.K.); (S.Y.S.); (K.L.); (S.H.H.)
- Correspondence: ; Tel.: +82-32-460-3054; Fax: +82-32-460-1901
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17
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Comparison between biodegradable- and durable-polymer everolimus-eluting stents in hemodialysis patients with coronary artery disease. Cardiovasc Interv Ther 2021; 37:475-482. [PMID: 34817827 DOI: 10.1007/s12928-021-00827-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2021] [Accepted: 11/15/2021] [Indexed: 10/19/2022]
Abstract
To investigate the clinical outcomes after biodegradable-polymer (BP) and durable-polymer (DP) everolimus-eluting stent (EES) implantation in hemodialysis (HD) patients with coronary artery disease. We enrolled 221 consecutive HD patients successfully treated with EES implantation for coronary lesions. Over the following 2 years, we assessed the incidence of target lesion revascularization (TLR) and major adverse cardiac event (MACE), defined as the composite endpoint of TLR, all-cause mortality, or myocardial infarction. We performed a propensity-score matching analysis and collected follow-up coronary angiography data. There were 91 patients in the BP-EES group and 130 in the DP-EES group. Male sex and diabetes rates were significantly lower in the BP-EES group than in the DP-EES group. A debulking device was less frequently used in the BP-EES group than in the DP-EES group (7.6% vs. 21.5%, p = 0.006). TLR occurred in 38 patients, while stent thrombosis was observed in 3 patients; 19 patients died. TLR and MACE rates at 2 years were comparable between the two groups (19.2% in the BP-EES group vs. 20.4% in the DP-EES group, p = 0.73 and 26.9% vs. 34.2%, p = 0.93, respectively). In the propensity-score-matched cohort, TLR and MACE rates were similar between the two groups (19.2% in the BP-EES group vs. 18.1% in the DP-EES group, p = 0.69, and 26.9% vs. 30.2%, p = 0.66, respectively). Restenosis rates at follow-up angiography were similar between the two groups (p = 0.79). In hemodialysis patients, BP-EES and DP-EES showed similar 2-year clinical outcomes.
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Jang W, Lee J, Song Y, Choi KH, Choi SH, Chun W, Oh J, Park I, Doh JH, Jeong JO, Park JS, Gwon HC, Hahn JY. A randomised comparison of coronary stents according to short or prolonged durations of dual antiplatelet therapy in patients with acute coronary syndromes: a pre-specified analysis of the SMART-DATE trial. EUROINTERVENTION 2021; 17:e411-e417. [PMID: 33136005 PMCID: PMC9724839 DOI: 10.4244/eij-d-20-00556] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
BACKGROUND Data on direct comparison between various drug-eluting stents with short duration dual antiplatelet therapy (DAPT) are limited, especially in patients with acute coronary syndrome (ACS). AIMS We sought to compare biodegradable polymer biolimus-eluting stents (BP-BES) with durable polymer everolimus-eluting (DP-EES) and zotarolimus-eluting stents (DP-ZES) in patients with ACS according to different durations of DAPT. METHODS In the SMART-DATE trial, 2,712 patients with ACS underwent randomisation for allocation of DAPT (6 months [n=1,357] or 12 months or longer [n=1,355]) and type of stent (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). The primary endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. RESULTS At 18 months, the primary endpoint was attained by 2.6% with BP-BES, 2.0% with DP-EES, and 2.1% with DP-ZES (HR 1.29, 95% CI: 0.70-2.39, p=0.42 for BP-BES vs DP-EES and HR 1.23, 95% CI: 0.67-2.26, p=0.50 for BP-BES vs DP-ZES). The treatment effect of BP-BES for the primary endpoint was consistent among patients receiving 6-month DAPT as well as those receiving 12-month or longer DAPT (BP-BES vs. DP-EES, pinteraction=0.48 and BP-BES vs DP-ZES, pinteraction=0.87). After excluding 179 patients (101 in the BP-BES group) who did not receive allocated DES, the per-protocol analysis showed similar results. CONCLUSIONS The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES versus DP-EES or DP-ZES across a short or prolonged duration of DAPT after ACS.
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Affiliation(s)
- Woo Jang
- Ewha Womans University College of Medicine, Seoul Hospital, Seoul, Republic of Korea
| | - Jin Lee
- Daegu Catholic University Medical Center, Daegu, Republic of Korea
| | - Young Song
- Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Ki Hong Choi
- Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Seung-Hyuk Choi
- Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Woo Chun
- Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea
| | - Ju Oh
- Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea
| | - Ik Park
- Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea
| | - Joon-Hyung Doh
- Inje University Ilsan Paik Hospital, Goyang, Republic of Korea
| | - Jin-Ok Jeong
- Chungnam National University Hospital, Daejeon, Republic of Korea
| | | | - Hyeon-Cheol Gwon
- Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Joo-Yong Hahn
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Republic of Korea
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Spione F, Brugaletta S. Second generation drug-eluting stents: a focus on safety and efficacy of current devices. Expert Rev Cardiovasc Ther 2021; 19:107-127. [PMID: 33417509 DOI: 10.1080/14779072.2021.1874352] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Abstract
Introduction: Percutaneous coronary intervention (PCI) represents the most frequent procedure performed in medicine. Second generation drug eluting stents (DES) have been developed to reduce the rates of late and very late complications of first generation DES.Areas covered: To improve long-term efficacy and safety of patients undergoing PCI, second generation DES have been developed with novel stent platforms, biocompatible durable and biodegradable polymers and newer antiproliferative agents. In this review we provide an overview of second generation DES and their clinical trials, discussing safety and effectiveness of these devices, and outlining clinical indication for use.Expert commentary: Numerous clinical trials have demonstrated the safety and efficacy of second generation DES over the last decade. These devices represent the gold standard treatment in stable and acute coronary syndromes.
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Affiliation(s)
- Francesco Spione
- Division of University Cardiology, Cardiothoracic Department, Policlinico University Hospital, Bari, Italy
| | - Salvatore Brugaletta
- Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain
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Yun KH, Lee SY, Cho BR, Jang WJ, Song YB, Oh JH, Chun WJ, Park YH, Im ES, Jeong JO, Oh SK, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC, Hahn JY. Safety of 3-Month Dual Antiplatelet Therapy After Implantation of Ultrathin Sirolimus-Eluting Stents With Biodegradable Polymer (Orsiro): Results From the SMART-CHOICE Trial. J Am Heart Assoc 2020; 10:e018366. [PMID: 33345567 PMCID: PMC7955499 DOI: 10.1161/jaha.120.018366] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
Background This study sought to investigate the safety of 3‐month dual antiplatelet therapy (DAPT) in patients receiving ultrathin sirolimus‐eluting stents with biodegradable polymer (Orsiro). Methods and Results The SMART‐CHOICE (Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Anti‐ platelet Therapy in Patients Undergoing Implantation of Coronary Drug‐Eluting Stents) randomized trial compared 3‐month DAPT followed by P2Y12 inhibitor monotherapy with 12‐month DAPT in 2993 patients undergoing percutaneous coronary intervention. The present analysis was a prespecified subgroup analysis for patients receiving Orsiro stents. As a post hoc analysis, comparisons between Orsiro and everolimus‐eluting stents were also done among patients receiving 3‐month DAPT. Of 972 patients receiving Orsiro stents, 481 patients were randomly assigned to 3‐month DAPT and 491 to 12‐month DAPT. At 12 months, the target vessel failure, defined as a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization, occurred in 8 patients (1.7%) in the 3‐month DAPT group and in 14 patients (2.9%) in the 12‐month DAPT group (hazard ratio [HR], 0.58; 95% CI, 0.24–1.39; P=0.22). In whole population who were randomly assigned to receive 3‐month DAPT (n=1495), there was no significant difference in the target vessel failure between the Orsiro group and the everolimus‐eluting stent group (n=1014) (1.7% versus 1.8%; HR, 0.96; 95% CI, 0.41–2.22; P=0.92). Conclusions In patients receiving Orsiro stents, clinical outcomes at 1 year were similar between the 3‐month DAPT followed by P2Y12 inhibitor monotherapy and 12‐month DAPT strategies. With 3‐month DAPT, there was no significant difference in target vessel failure between Orsiro and everolimus‐eluting stents. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02079194.
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Affiliation(s)
- Kyeong Ho Yun
- Regional Cardiocerebrovascular Center Wonkwang University Hospital Iksan Korea
| | - Seung-Yul Lee
- Regional Cardiocerebrovascular Center Wonkwang University Hospital Iksan Korea
| | | | - Woo Jin Jang
- Samsung Changwon Hospital Sungkyunkwan University School of Medicine Changwon Korea
| | - Young Bin Song
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Ju-Hyeon Oh
- Samsung Changwon Hospital Sungkyunkwan University School of Medicine Changwon Korea
| | - Woo Jung Chun
- Samsung Changwon Hospital Sungkyunkwan University School of Medicine Changwon Korea
| | - Yong Hwan Park
- Samsung Changwon Hospital Sungkyunkwan University School of Medicine Changwon Korea
| | | | - Jin-Ok Jeong
- Chungnam National University Hospital Daejeon Korea
| | - Seok Kyu Oh
- Regional Cardiocerebrovascular Center Wonkwang University Hospital Iksan Korea
| | | | - Jong-Young Lee
- Kangbuk Samsung Hospital Sungkyunkwan University School of Medicine Seoul Korea
| | | | - Jang-Whan Bae
- Chungbuk National University Hospital Cheongju Korea
| | | | | | | | | | | | | | | | - Joo Myung Lee
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Taek Kyu Park
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Jeong Hoon Yang
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Jin-Ho Choi
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Seung-Hyuck Choi
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Sang Hoon Lee
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Hyeon-Cheol Gwon
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
| | - Joo-Yong Hahn
- Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
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Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Kim SY, Park KH, Rha SW, Shin WY, Lim HS, Park K, Park KW. Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial. Circulation 2020; 143:1081-1091. [PMID: 33205662 DOI: 10.1161/circulationaha.120.051700] [Citation(s) in RCA: 32] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Large-scale randomized comparison of drug-eluting stents (DES) based on durable polymer versus biodegradable polymer technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study aimed to prove the noninferiority of the durable polymer DES (DP-DES) compared with the biodegradable polymer DES (BP-DES) in such patients. METHODS The HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, noninferiority trial comparing the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary end point was a patient-oriented composite outcome (a composite of all-cause death, nonfatal myocardial infarction, and any repeat revascularization) at 12 months. The key secondary end point was device-oriented composite outcome (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) at 12 months. RESULTS A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, patient-oriented composite outcome occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (absolute risk difference, -1.2%; Pnoninferiority<0.001). The key secondary end point, device-oriented composite outcome, occurred less frequently in the DP-DES group (DP-DES vs BP-DES, 2.6% vs 3.9%; hazard ratio, 0.67 [95% CI, 0.46-0.98]; P=0.038), mostly because of a reduction in target lesion revascularization. The rate of spontaneous nonfatal myocardial infarction and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% versus 0.8%; P=0.513 and 0.1% versus 0.4%; P=0.174, respectively). CONCLUSIONS In ACS patients receiving percutaneous coronary intervention, DP-DES was noninferior to BP-DES with regard to patient-oriented composite outcomes at 12 months after index percutaneous coronary intervention. Registration: URL: https://wwwclinicaltrials.gov; Unique identifier: NCT02193971.
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Affiliation(s)
- Hyo-Soo Kim
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
| | - Jeehoon Kang
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
| | - Doyeon Hwang
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
| | - Jung-Kyu Han
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
| | - Han-Mo Yang
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
| | - Hyun-Jae Kang
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
| | - Bon-Kwon Koo
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
| | | | - Keun-Ho Park
- Chosun University Hospital, Gwangju, Korea (K-H.P.)
| | | | - Won-Yong Shin
- Soon Chun Hyang University Cheonan Hospital, Cheonan, Korea (W-Y.S.)
| | - Hong-Seok Lim
- Ajou University School of Medicine, Suwon, Korea (H-S.L.)
| | | | - Kyung Woo Park
- Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.)
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22
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Nakamura M, Ike A, Kato Y, Futami M, Kuwano T, Sugihara M, Iwata A, Kawamura A, Suematsu Y, Miura SI. Differences in lesion characteristics and patient background associated with the medium-term clinical outcomes of bare-metal and first-, second- and third-generation drug-eluting stents. Heart Vessels 2020; 36:211-222. [PMID: 32918197 DOI: 10.1007/s00380-020-01692-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/28/2020] [Accepted: 08/28/2020] [Indexed: 01/23/2023]
Abstract
We investigated the lesion characteristics and patient background factors associated with the medium-term incidence of major adverse cardiac events (MACEs) for bare-metal stents (BMS) and 1st-, 2nd- and 3rd-generation drug-eluting stents (DES) using the PCI-Registry (FU-Registry). Between January 2003 and March 2016, 2967 cases/3508 lesions for which percutaneous coronary intervention was performed at Fukuoka University Hospital and related facilities were enrolled. Patients were divided into BMS and 1st-, 2nd- and 3rd-generation drug-eluting stent (DES) groups. The incidence of MACEs in the BMS group (26.2%) was significantly higher than those in the 1st, 2nd and 3rd DES groups (18.0%, 12.5%, and 11.0%, respectively). The incidence of MACEs in the BMS group was strongly associated with insulin use, hemodialysis, low high-density lipoprotein cholesterol, stent minimum lesion diameter, stent length, severe calcification and a small vessel diameter of less than 2.5 mm. Some of these factors showed no association with MACEs among the drug-elution groups, and only hemodialysis, arteriosclerosis obliterans and severe calcification showed a strong correlation in the 2nd DES group. In the 3rd DES group, none of the factors considered were associated with MACEs. In conclusion, in stent implantation, the number of factors associated with MACEs has gradually decreased as the stent generation increased.
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Affiliation(s)
- Masayuki Nakamura
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Amane Ike
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
| | - Yuta Kato
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Makito Futami
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Takashi Kuwano
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Makoto Sugihara
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Atsushi Iwata
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Akira Kawamura
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Yasunori Suematsu
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
| | - Shin-Ichiro Miura
- Department of Cardiology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. .,Department of Cardiology, Fukuoka University Nishijin Hospital, 15-7 Sohara, Sawara-Ku, Fukuoka, 814-8522, Japan.
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Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2020; 40:87-165. [PMID: 30165437 DOI: 10.1093/eurheartj/ehy394] [Citation(s) in RCA: 4436] [Impact Index Per Article: 887.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
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Lupi A, Ugo F, De Martino L, Infantino V, Iannaccone M, Iorio S, Di Leo A, Colangelo S, Zanera M, Schaffer A, Persampieri S, Garbo R, Senatore G. Real-World Experience With a Tapered Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With Long Coronary Artery Stenoses. Cardiol Res 2020; 11:219-225. [PMID: 32595806 PMCID: PMC7295557 DOI: 10.14740/cr1055] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2020] [Accepted: 04/20/2020] [Indexed: 12/14/2022] Open
Abstract
Background Treatment of long coronary stenoses (LCS) with long tapered drug-eluting stents (LT-DES) would offer clinical and economic benefits. However, the feasibility of an interventional strategy based upon the systematic LCS treatment with an LT-DES has not been evaluated so far. Methods We performed a multicenter prospective study including consecutive patients with: 1) An LCS > 25 mm at coronary angiography; 2) An attempt to fix the LCS with a single BioMime Morph™ stent, a novel LT-DES available from 30 to 60 mm long. The primary efficacy endpoint was procedural success. The secondary safety endpoints were post-procedural TIMI3 flow, stent detachment during delivery, acute stent thrombosis and in-hospital mortality. Results From February 2017 to March 2018, we recorded 272 patients with an LCS and an attempt to deploy an LT-DES during percutaneous coronary intervention (PCI) (69.3 ± 11.4 years, 75.7% males, 25.7% diabetic and 43.8% with acute coronary syndromes, mean LCS length 48.8 ± 9.5 mm). LT-DES deployment was successful in 262 patients (96.3%), and failure occurred without stent detachment or other complications. Final TIMI3 flow was present in 270 (99.3%) patients. In-hospital death occurred in five patients (1.8%), with no case of acute stent thrombosis, recurrent myocardial infarction or repeated revascularization. Conclusion In this real-world study, a strategy of fixing LCS with a single LT-DES was feasible and safe, with a high rate of procedural success and a low rate of in-hospital complications. More extensive randomized studies are warranted to assess the potential clinical and economic benefits of LT-DES.
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Affiliation(s)
- Alessandro Lupi
- SOC Cardiologia, Ospedali Riuniti di Domodossola e Verbania, Italy
| | - Fabrizio Ugo
- Department of Invasive Cardiology, Ospedale San Giovanni Bosco, Turin, Italy
| | | | | | - Mario Iannaccone
- Department of Invasive Cardiology, Ospedale San Giovanni Bosco, Turin, Italy
| | - Sergio Iorio
- SOC Cardiologia, Ospedali Riuniti di Domodossola e Verbania, Italy
| | - Angelo Di Leo
- Department of Cardiology, Ospedale Civile, Cirie, Italy
| | - Salvatore Colangelo
- Department of Invasive Cardiology, Ospedale San Giovanni Bosco, Turin, Italy
| | - Marco Zanera
- Department of Cardiology, Ospedale Civile, Cirie, Italy
| | - Alon Schaffer
- SOC Cardiologia, Ospedali Riuniti di Domodossola e Verbania, Italy
| | | | - Roberto Garbo
- Department of Invasive Cardiology, Ospedale San Giovanni Bosco, Turin, Italy
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Parker W, Iqbal J. Comparison of Contemporary Drug-eluting Coronary Stents - Is Any Stent Better than the Others? Heart Int 2020; 14:34-42. [PMID: 36277668 PMCID: PMC9524693 DOI: 10.17925/hi.2020.14.1.34] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2019] [Accepted: 03/09/2020] [Indexed: 11/01/2023] Open
Abstract
Percutaneous coronary intervention (PCI) with implantation of a metallic drug-eluting stent (DES) is the mainstay of treatment in patients with significant coronary artery disease or acute coronary syndromes. DESs comprise a metallic platform and an anti-proliferative drug, usually released from a polymer coating. A wide range of DESs, differing in platform, polymer or drug, are currently available for clinical use. Although there are significant differences in the physical, biological and pharmacological properties of contemporary DESs, it remains unclear whether these impact meaningfully on clinical outcomes for patients undergoing PCI. Numerous randomised clinical trials have compared DESs in recent years, but these trials are typically designed to show non-inferiority, rather than superiority. Data from meta-analyses have helped to study this in larger populations, but have limitations. Improvement in stent design continues and ongoing work is exploring the effects of new innovations as well as gathering further data on existing devices. This review explores the development, properties and clinical efficacy of current-generation DESs, comparing different types where possible, whilst identifying areas of further work.
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Affiliation(s)
- William Parker
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK
| | - Javaid Iqbal
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK
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Nakamura M, Kadota K, Takahashi A, Kanda J, Anzai H, Ishii Y, Shibata Y, Yasaka Y, Takamisawa I, Yamaguchi J, Takeda Y, Harada A, Motohashi T, Iijima R, Uemura S, Murakami Y. Relationship Between Platelet Reactivity and Ischemic and Bleeding Events After Percutaneous Coronary Intervention in East Asian Patients: 1-Year Results of the PENDULUM Registry. J Am Heart Assoc 2020; 9:e015439. [PMID: 32394794 PMCID: PMC7660889 DOI: 10.1161/jaha.119.015439] [Citation(s) in RCA: 42] [Impact Index Per Article: 8.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background The balance between ischemic and bleeding events and their association with platelet reactivity in patients receiving antiplatelet therapy after percutaneous coronary intervention (PCI), which differs among regions, is not fully evaluated for East Asians. We examined ischemic/bleeding events and platelet reactivity in Japanese patients undergoing PCI and determined associations between high/low platelet reactivity and clinical outcomes. Methods and Results PENDULUM (Platelet Reactivity in Patients with Drug Eluting Stent and Balancing Risk of Bleeding and Ischemic Event) is a prospective, multicenter registry of Japanese patients with PCI. Primary end points were incidence of first major adverse cardiac and cerebrovascular events (MACCE) and first major bleeding events at 12 months post-PCI. Platelet reactivity (P2Y12 reaction unit [PRU] value) was measured at 12 to 48 hours post-PCI; patients were grouped as having high PRU (>208), optimal PRU (>85 to ≤208), and low PRU (≤85). MACCE and major bleeding occurred in 4.4% and 2.8% of 6267 patients, respectively. The mean±SD PRU value was 182.1±77.1. MACCE was significantly higher in the high PRU (5.7%; n=2227) versus the optimal PRU group (3.6%; n=3002). The hazard ratio (HR) for high PRU versus optimal PRU level was significantly higher for MACCE (adjusted HR, 1.53; 95% CI, 1.14-2.06 [P=0.004]); stent thrombosis followed the same trend. Incidence of major bleeding did not differ significantly between groups. A high PRU level was significantly associated with MACCE in both patients with and patients without acute coronary syndrome. Conclusions These real-world data suggest an association between high platelet reactivity and cardiovascular events in Japanese patients undergoing PCI. The trend was the same in both patients with and patients without acute coronary syndrome. REGISTRATION URL: https://www.umin.ac.jp/ctr. Unique identifier: UMIN 000020332.
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Affiliation(s)
- Masato Nakamura
- Division of Cardiovascular Medicine Toho University Ohashi Medical Center Tokyo Japan
| | - Kazushige Kadota
- Department of Cardiology Kurashiki Central Hospital Kurashiki Japan
| | | | - Junji Kanda
- Department of Cardiology Asahi General Hospital Asahi Japan
| | - Hitoshi Anzai
- Department of Cardiology Ota Memorial Hospital Ota Japan
| | - Yasuhiro Ishii
- Department of Cardiology Cardiovascular Center Ogikubo Hospital Tokyo Japan
| | - Yoshisato Shibata
- Department of Cardiology Miyazaki Medical Association Hospital Miyazaki Japan
| | - Yoshinori Yasaka
- Department of Cardiology Himeji Cardiovascular Center Himeji Japan
| | | | - Junichi Yamaguchi
- Department of Cardiology Tokyo Women's Medical University Tokyo Japan
| | - Yoshihiro Takeda
- Department of Cardiology Rinku General Medical Center Izumisano Japan
| | - Atsushi Harada
- Medical Science Department Daiichi Sankyo Co., Ltd. Tokyo Japan
| | - Tomoko Motohashi
- Medical Affairs Planning Department Daiichi Sankyo Co., Ltd. Tokyo Japan
| | - Raisuke Iijima
- Division of Cardiovascular Medicine Toho University Ohashi Medical Center Tokyo Japan
| | - Shiro Uemura
- Department of Cardiology Kawasaki Medical School Kurashiki Japan
| | - Yoshitaka Murakami
- Department of Medical Statistics School of Medicine Toho University Tokyo Japan
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Clinical expert consensus document on quantitative coronary angiography from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther 2020; 35:105-116. [PMID: 32125622 PMCID: PMC7105443 DOI: 10.1007/s12928-020-00653-7] [Citation(s) in RCA: 79] [Impact Index Per Article: 15.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2020] [Accepted: 02/19/2020] [Indexed: 01/15/2023]
Abstract
Quantitative coronary angiography (QCA) remains to play an important role in clinical trials and post-marketing surveillance related to the safety and efficacy of new PCI devices. In this document, the current standard methodology of QCA is summarized. In addition, its history, recent development and future perspectives are also reviewed.
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Youn YJ, Lee JW, Ahn SG, Lee SH, Yoon J, Park KS, Lee JB, Yoo SY, Lim DS, Cho JH, Choi CU, Jeong MH, Han KR, Cha KS, Lee SY, Choi HH, Choi JW, Hyon MS, Kim MH. Randomized Comparison of Everolimus- and Zotarolimus-Eluting Coronary Stents With Biolimus-Eluting Stents in All-Comer Patients. Circ Cardiovasc Interv 2020; 13:e008525. [DOI: 10.1161/circinterventions.119.008525] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background:
There is limited data comparing the Xience everolimus-eluting stent (EES) and the Resolute zotarolimus-eluting stent (ZES) with the BioMatrix biolimus-eluting stent (BES).
Methods:
This open-label, randomized, noninferiority trial enrolled all-comer patients to be randomly treated with either BES, EES, or ZES in a 1:1:1 ratio in 15 centers across South Korea. The primary end point was a device-oriented composite outcome consisting of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization at 24 months. The BES was compared with the EES and the ZES by intention-to-treat analyses with a noninferiority margin of 3.8%, respectively.
Results:
Because of slow recruitment and low event rates, this trial was prematurely terminated after enrollment of 1935 (75%) of the intended 2580 patients. Of the 1911 patients randomized to either EES (n=638), BES (n=634), or ZES (n =639), the rate of device-oriented composite outcome was 3.6%, 2.2%, and 3.9%, respectively, at 24 months (BES versus EES: absolute risk difference −1.4% [upper limit of 1-sided 95% CI: −3.2%];
P
for noninferiority
<0.001; BES versus ZES: absolute risk difference −1.7% [upper limit of 1-sided 95% CI: −3.6%];
P
for noninferiority
<0.001).
Conclusions:
The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up. However, caution is advised regarding interpretation of these results due to the premature termination of this study.
Registration:
URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT01397175.
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Affiliation(s)
- Young Jin Youn
- Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.)
| | - Jun-Won Lee
- Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.)
| | - Sung Gyun Ahn
- Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.)
| | - Seung-Hwan Lee
- Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.)
| | - Junghan Yoon
- Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.)
| | - Keum Soo Park
- Division of Cardiology, Inha University Hospital, Inha University College of Medicine, Incheon, South Korea (K.S.P.)
| | - Jin Bae Lee
- Division of Cardiology, Daegu Catholic University Medical Center, Catholic University, South Korea (J.-B.L.)
| | - Sang-Yong Yoo
- Division of Cardiology, Gangneung Asan Hospital, University of Ulsan College of Medicine, South Korea (S.-Y.Y.)
| | - Do-Sun Lim
- Division of Cardiology, Korea University Anam Hospital (D.-S.L.), Korea University, Seoul, South Korea
| | - Jang Hyun Cho
- Division of Cardiology, St. Carollo General Hospital, Suncheon, South Korea (J.H.C.)
| | - Cheol Ung Choi
- Division of Cardiology, Korea University Guro Hospital (C.U.C.), Korea University, Seoul, South Korea
| | - Myung Ho Jeong
- The Heart Center, Chonnam National University Hospital, Chonnam National University, Gwangju, South Korea (M.H.J.)
| | - Kyoo-Rok Han
- Division of Cardiology, Kangdong Sacred Heart Hospital Hallym University, Seoul (K.-R.H.)
| | - Kwang Soo Cha
- Division of Cardiology, Pusan National University Hospital, Pusan National University, Busan, South Korea (K.S.C.)
| | - Sung Yun Lee
- Division of Cardiology, Inje University Ilsan-Paik Hospital, Inje University, Goyang, South Korea (S.Y.L.)
| | - Hyun-Hee Choi
- Division of Cardiology, Chuncheon Sacred Heart Hospital, Hallym University, South Korea (H.-H.C.)
| | - Jae Woong Choi
- Division of Cardiology, Eulji General Hospital, Eulji University, Seoul, South Korea (J.W.C.)
| | - Min Su Hyon
- Division of Cardiology, Soonchunhyang University Seoul Hospital, Soonchunhyang University, South Korea (M.S.H.)
| | - Moo-Hyun Kim
- Division of Cardiology, Dong-A University Hospital, Dong-A University, Busan, South Korea (M.-H.K.)
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Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry. J Interv Cardiol 2020; 2020:3872704. [PMID: 32180687 PMCID: PMC7061140 DOI: 10.1155/2020/3872704] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2019] [Accepted: 01/31/2020] [Indexed: 11/17/2022] Open
Abstract
Objective In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%. Conclusions In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.
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Yamamoto K, Shiomi H, Morimoto T, Natsuaki M, Takeji Y, Watanabe H, Yoshikawa Y, Matsumura-Nakano Y, Shizuta S, Tanabe K, Ando K, Kadota K, Morino Y, Kozuma K, Nakagawa Y, Kimura T. Effect of Renal Dysfunction on the Risks for Ischemic and Bleeding Events in Patients With Atrial Fibrillation Receiving Percutaneous Coronary Intervention. Am J Cardiol 2020; 125:399-408. [PMID: 31771755 DOI: 10.1016/j.amjcard.2019.10.049] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2019] [Revised: 10/23/2019] [Accepted: 10/28/2019] [Indexed: 11/18/2022]
Abstract
There is a paucity of studies exploring whether the ischemia-bleeding trade-off could be different according to the stages of renal dysfunction in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI). Among 19,598 patients in a pooled database from 3 Japanese PCI studies (CREDO-Kyoto Cohort-2, RESET, and NEXT), 1,547 patients had concomitant AF. Patients were divided into 4 groups according to their renal function (Creatinine clearance [CCr] >60 ml/min: n = 703, 60≥ CCr >30 ml/min: n = 627, CCr ≤30 ml/min: n = 126, Dialysis: n = 91). The cumulative 3-year incidences of both the primary ischemic (ischemic stroke/myocardial infarction) and bleeding (GUSTO moderate/severe) outcome increased incrementally with worsening renal function (11.4%, 12.6%, 16.8%, and 31.7%, p <0.001, and 7.5%, 14.9%, 26.3%, and 29.5%, p <0.001, respectively). Compared with CCr >60 ml/min group, the excess adjusted risk for the primary ischemic outcome was significant only in dialysis group (hazards ratio [HR] 2.15, 95% confidence interval [CI] 1.22 to 3.69, p = 0.009), but not in 60≥ CCr >30 ml/min and CCr ≤30 ml/min groups (HR 0.89, 95% CI 0.62 to 1.29, p = 0.54, and HR 0.94, 95% CI 0.49 to 1.69, p = 0.83, respectively), whereas the excess adjusted risk for the primary bleeding outcome was significant in all 3 groups of renal dysfunction (HR 1.66, 95% CI 1.13 to 2.45, p = 0.01, HR 2.70, 95% CI 1.58 to 4.61, p <0.001, and HR 3.26, 95% CI 1.85 to 5.75, p <0.001, respectively). In conclusion, in AF patients receiving PCI, the worsening renal function was strongly associated with the increasingly higher risk for bleeding events, whereas the excess risk for ischemic events was significant only in patients on dialysis.
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Affiliation(s)
- Ko Yamamoto
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Hiroki Shiomi
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
| | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
| | | | - Yasuaki Takeji
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Hirotoshi Watanabe
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Yusuke Yoshikawa
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Yukiko Matsumura-Nakano
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Satoshi Shizuta
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Kenji Ando
- Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
| | - Kazushige Kadota
- Division of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Yoshihiro Morino
- Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan
| | - Ken Kozuma
- Division of Cardiology, Teikyo University Hospital, Tokyo, Japan
| | - Yoshihisa Nakagawa
- Department of Cardiovascular Medicine, Shiga University of Medical Science Hospotal, Otsu, Japan
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
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31
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Chang CC, Kogame N, Onuma Y, Byrne RA, Capodanno D, Windecker S, Morel MA, Cutlip DE, Krucoff MW, Stone GW, Lansky AJ, Mehran R, Spitzer E, Fraser AG, Baumbach A, Serruys PW. Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. EUROINTERVENTION 2020; 15:1190-1198. [DOI: 10.4244/eij-d-19-00552] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
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32
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Zhang H, Zhang X, Yin Y, Zhou C, Deng W, Zhang J, Hou W, Lu S, Song C, Cui X, Wang S, Yang F, Liu G, Duan C, Ge J. An abluminal biodegradable polymer sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients undergoing coronary revascularization: 3-year clinical outcomes of a randomized non-inferiority trial. Sci Rep 2019; 9:18549. [PMID: 31811206 PMCID: PMC6898363 DOI: 10.1038/s41598-019-54964-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2019] [Accepted: 11/19/2019] [Indexed: 11/09/2022] Open
Abstract
The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI −1.0–1.5%, Pnon-inferiority < 0.0001). At 3 years, the primary safety endpoint occurred in 39 (1.6%) patients in the Cordimax group versus 19 (1.5%) patients in the Xience V group (0.05% absolute risk difference, 95% CI −0.8–0.9%, Pnon-inferiority < 0.0001). The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.
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Affiliation(s)
- Haijun Zhang
- Intervention & Vascular Surgery, Medical College of Tongji University, Shanghai, China.,Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg Ø, Denmark.,National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Xiaoping Zhang
- Intervention & Vascular Surgery, Medical College of Tongji University, Shanghai, China.
| | - Yuxia Yin
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Chao Zhou
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Wei Deng
- Key Laboratory of Public Health Safety, Ministry of Education, School of Public Health, Fudan University, Shanghai, China
| | - Junwei Zhang
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Wenbo Hou
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Shoutao Lu
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Caixia Song
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Xiaoshan Cui
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Shenguo Wang
- Institute of Chemistry, Chinese Academy of Sciences, Beijing, China
| | - Fei Yang
- Institute of Chemistry, Chinese Academy of Sciences, Beijing, China
| | - Guang Liu
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Cuihai Duan
- National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China
| | - Junbo Ge
- Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
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Omar WA, Kumbhani DJ. The Current Literature on Bioabsorbable Stents: a Review. Curr Atheroscler Rep 2019; 21:54. [DOI: 10.1007/s11883-019-0816-4] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
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Nagao K, Watanabe H, Morimoto T, Inada T, Hayashi F, Nakagawa Y, Furukawa Y, Kadota K, Akasaka T, Natsuaki M, Kozuma K, Tanabe K, Morino Y, Shiomi H, Kimura T. Prognostic Impact of Baseline Hemoglobin Levels on Long-Term Thrombotic and Bleeding Events After Percutaneous Coronary Interventions. J Am Heart Assoc 2019; 8:e013703. [PMID: 31701786 PMCID: PMC6915278 DOI: 10.1161/jaha.119.013703] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
Background Association of baseline hemoglobin levels with long‐term adverse events after percutaneous coronary interventions has not been yet thoroughly defined. We aimed to assess the clinical impact of baseline hemoglobin on long‐term ischemic and bleeding risk after percutaneous coronary intervention. Methods and Results Using the pooled individual patient‐level data from the 3 percutaneous coronary intervention studies, we categorized 19 288 patients into 4 groups: high‐normal hemoglobin (≥14.0 g/dL; n=7555), low‐normal hemoglobin (13.0–13.9 g/dL in men and 12.0–13.9 g/dL in women; n=5303), mild anemia (11.0–12.9 g/dL in men and 11.0–11.9 g/dL in women; n=4117), and moderate/severe anemia (<11.0 g/dL; n=2313). Median follow‐up duration was 3 years. Low‐normal hemoglobin, mild anemia, and moderate/severe anemia correlated with significant excess risk relative to high‐normal hemoglobin for GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries Trial) moderate/severe bleeding, with adjusted hazard ratios of 1.22 (95% CI, 1.04–1.44), 1.73 (95% CI, 1.47–2.04), and 2.31 (95% CI, 1.92–2.78), respectively. Moderate/severe anemia also correlated with significant excess risk relative to high‐normal hemoglobin for the ischemic composite end point of myocardial infarction/ischemic stroke (adjusted hazard ratio, 1.33; 95% CI, 1.11–1.60), whereas low‐normal hemoglobin and mild anemia did not. However, the excess risk of low‐normal hemoglobin, mild anemia, and moderate/severe anemia relative to high‐normal hemoglobin remained significant for ischemic stroke and for mortality. Conclusions Decreasing baseline hemoglobin correlated with incrementally higher long‐term risk for major bleeding, ischemic stroke, and mortality after percutaneous coronary intervention. Even within normal range, lower baseline hemoglobin level correlated with higher ischemic and bleeding risk.
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Affiliation(s)
- Kazuya Nagao
- Department of Cardiovascular Center Osaka Red Cross Hospital Osaka Japan
| | - Hirotoshi Watanabe
- Department of Cardiovascular Medicine Kyoto University Graduate School of Medicine Kyoto Japan
| | - Takeshi Morimoto
- Department of Clinical Epidemiology Hyogo College of Medicine Nishinomiya Japan
| | - Tsukasa Inada
- Department of Cardiovascular Center Osaka Red Cross Hospital Osaka Japan
| | - Fujio Hayashi
- Department of Cardiovascular Center Osaka Red Cross Hospital Osaka Japan
| | - Yoshihisa Nakagawa
- Department of Cardiovascular and Respiratory Medicine Shiga University of Medical Science Otsu Japan
| | - Yutaka Furukawa
- Department of Cardiovascular Medicine Kobe City Medical Center General Hospital Kobe Japan
| | - Kazushige Kadota
- Department of Cardiology Kurashiki Central Hospital Kurashiki Japan
| | - Takashi Akasaka
- Department of Cardiovascular Medicine Wakayama Medical University Wakayama Japan
| | | | - Ken Kozuma
- Department of Cardiology Teikyo University Hospital Tokyo Japan
| | - Kengo Tanabe
- Department of Cardiology Mitsui Memorial Hospital Tokyo Japan
| | - Yoshihiro Morino
- Department of Cardiology Iwate University Hospital Morioka Japan
| | - Hiroki Shiomi
- Department of Cardiovascular Medicine Kyoto University Graduate School of Medicine Kyoto Japan
| | - Takeshi Kimura
- Department of Cardiovascular Medicine Kyoto University Graduate School of Medicine Kyoto Japan
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Natsuaki M, Morimoto T, Watanabe H, Nakagawa Y, Furukawa Y, Kadota K, Akasaka T, Hanaoka KI, Kozuma K, Tanabe K, Morino Y, Muramatsu T, Kimura T. Ischemic and Bleeding Risk After Percutaneous Coronary Intervention in Patients With Prior Ischemic and Hemorrhagic Stroke. J Am Heart Assoc 2019; 8:e013356. [PMID: 31701821 PMCID: PMC6915281 DOI: 10.1161/jaha.119.013356] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
Background Prior stroke is regarded as risk factor for bleeding after percutaneous coronary intervention (PCI). However, there is a paucity of data on detailed bleeding risk of patients with prior hemorrhagic and ischemic strokes after PCI. Methods and Results In a pooled cohort of 19 475 patients from 3 Japanese PCI studies, we assessed the influence of prior hemorrhagic (n=285) or ischemic stroke (n=1773) relative to no-prior stroke (n=17 417) on ischemic and bleeding outcomes after PCI. Cumulative 3-year incidences of the co-primary bleeding end points of intracranial hemorrhage, non-intracranial global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO) moderate/severe bleeding, and the primary ischemic end point of ischemic stroke/myocardial infarction were higher in the prior hemorrhagic and ischemic stroke groups than in the no-prior stroke group (6.8%, 2.5%, and 1.3%, P<0.0001, 8.8%, 8.0%, and 6.0%, P=0.001, and 12.7%, 13.4%, and 7.5%, P<0.0001). After adjusting confounders, the excess risks of both prior hemorrhagic and ischemic strokes relative to no-prior stroke remained significant for intracranial hemorrhage (hazard ratio (HR) 4.44, 95% CI 2.64-7.01, P<0.0001, and HR 1.52, 95% CI 1.06-2.12, P=0.02), but not for non-intracranial bleeding (HR 1.18, 95% CI 0.76-1.73, P=0.44, and HR 0.94, 95% CI 0.78-1.13, P=0.53). The excess risks of both prior hemorrhagic and ischemic strokes relative to no-prior stroke remained significant for ischemic events mainly driven by the higher risk for ischemic stroke (HR 1.46, 95% CI 1.02-2.01, P=0.04, and HR 1.49, 95% CI 1.29-1.72, P<0.0001). Conclusions Patients with prior hemorrhagic or ischemic stroke as compared with those with no-prior stroke had higher risk for intracranial hemorrhage and ischemic events, but not for non-intracranial bleeding after PCI.
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Affiliation(s)
| | - Takeshi Morimoto
- Department of Clinical Epidemiology Hyogo College of Medicine Nishinomiya Japan
| | - Hirotoshi Watanabe
- Department of Cardiovascular Medicine Graduate School of Medicine Kyoto University Kyoto Japan
| | - Yoshihisa Nakagawa
- Department of Cardiovascular Medicine Shiga University of Medical Science Hospital Otsu Japan
| | - Yutaka Furukawa
- Department of Cardiovascular Medicine Kobe City Medical Center General Hospital Kobe Japan
| | - Kazushige Kadota
- Division of Cardiology Kurashiki Central Hospital Kurashiki Japan
| | - Takashi Akasaka
- Department of Cardiovascular Medicine Wakayama Medical University Wakayama Japan
| | | | - Ken Kozuma
- Division of Cardiology Teikyo University Hospital Tokyo Japan
| | - Kengo Tanabe
- Division of Cardiology Mitsui Memorial Hospital Tokyo Japan
| | - Yoshihiro Morino
- Division of Cardiology Iwate Medical University Hospital Morioka Japan
| | | | - Takeshi Kimura
- Department of Cardiovascular Medicine Graduate School of Medicine Kyoto University Kyoto Japan
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36
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Natsuaki M, Morimoto T, Shiomi H, Yamaji K, Watanabe H, Shizuta S, Kato T, Ando K, Nakagawa Y, Furukawa Y, Tada T, Nagao K, Kadota K, Toyofuku M, Kimura T. Application of the Academic Research Consortium High Bleeding Risk Criteria in an All-Comers Registry of Percutaneous Coronary Intervention. Circ Cardiovasc Interv 2019; 12:e008307. [DOI: 10.1161/circinterventions.119.008307] [Citation(s) in RCA: 82] [Impact Index Per Article: 13.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background:
Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice.
Methods:
We applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group.
Results:
Cumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year,
P
<0.0001). Presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and prior ischemic stroke, was also associated with major bleeding risk higher than 4% at 1-year. Cumulative 5-year incidence of the primary bleeding end point got incrementally higher as the number of the ARC-HBR major criteria increased (≥3 majors: 49.9%, 2 majors: 30.6%, 1 major: 18.5%, ≥2 minors: 14.7%, and no-HBR: 6.6%,
P
<0.0001).
Conclusions:
ARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry.
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Affiliation(s)
- Masahiro Natsuaki
- Department of Cardiovascular Medicine, Saga University, Japan (M.N.)
| | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T.M.)
| | - Hiroki Shiomi
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura)
| | - Kyohei Yamaji
- Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan (K.Y., K.A.)
| | - Hirotoshi Watanabe
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura)
| | - Satoshi Shizuta
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura)
| | - Takao Kato
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura)
| | - Kenji Ando
- Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan (K.Y., K.A.)
| | - Yoshihisa Nakagawa
- Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital, Otsu, Japan (Y.N.)
| | - Yutaka Furukawa
- Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Japan (Y.F.)
| | - Tomohisa Tada
- Division of Cardiology, Shizuoka General Hospital, Japan (T.T.)
| | - Kazuya Nagao
- Department of Cardiovascular Center, Osaka Red Cross Hospital, Japan (K.N.)
| | - Kazushige Kadota
- Division of Cardiology, Kurashiki Central Hospital, Japan (K.K.)
| | - Mamoru Toyofuku
- Division of Cardiology, Wakayama Red Cross Hospital, Wakayama, Japan (M.T.)
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura)
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37
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Roguin A, Kandzari DE, Marcusohn E, Koolen JJ, Doros G, Massaro JM, Garcia-Garcia HM, Bennett J, Gharib EG, Cutlip DE, Waksman R. Subgroup Analysis Comparing Ultrathin, Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin, Durable Polymer Everolimus-Eluting Stents in Acute Coronary Syndrome Patients. Circ Cardiovasc Interv 2019; 11:e007331. [PMID: 30354631 DOI: 10.1161/circinterventions.118.007331] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Presentation with acute coronary syndromes (ACS) constitutes a high-risk subset of patients with worse outcome after percutaneous coronary intervention. We report clinical outcomes in subjects with ACS from the BIOFLOW V trial (BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions) comparing an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP-SES) with a thin strut (81 μm) durable polymer everolimus-eluting stent (DP-EES). METHODS AND RESULTS Among 1334 patients randomized to 2:1 treatment with either BP-SES or DP-EES, 677 (50.7%) ACS patients without ST-segment-elevation myocardial infarction (MI; 454 BP-SES and 223 DP-EES) were identified in the retrospective post hoc analysis. The primary end point of 12-month target lesion failure, individual component end points, and stent thrombosis were evaluated. Recurrent MI was defined as a ≥50% increase of creatine kinase-myocardial band or in the absence of creatine kinase-myocardial band, troponin >50% increase over previous level and >3× the upper limit of normal). All events were adjudicated by a blinded independent clinical events committee. Overall, baseline clinical, angiographic, and procedural characteristics of the ACS population were similar between the 2 treatment groups. At 12 months, target lesion failure occurred in 5.6% (24/426) of BP-SES patients versus 11.0% (23/209) in DP-EES patients ( P=0.02); target lesion failure composite components were cardiac death, 0% versus 1.0% ( P=0.11); target vessel-related MI, 3.5% versus 9.7% ( P=0.003); and clinically driven target lesion revascularization, 2.8% versus 3.4% ( P=0.80). Spontaneous target vessel MI was 0.5% (2/425) for BP-SES versus 2.4% (5/206) for DP-EES ( P=0.041). Stent thrombosis rates at 1 year were similar (0.5% versus 1.0%; P=0.601). CONCLUSIONS In the ACS subgroup population of the BIOFLOW V study, treatment with BP-SES compared with DP-EES was associated with a significantly lower rate of 12-month target lesion failure, a difference driven by significantly lower periprocedural MI and spontaneous MI. These findings support treatment with an ultrathin strut BP-SES in ACS patients undergoing percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT02389946.
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Affiliation(s)
- Ariel Roguin
- Rambam Medical Center, Haifa, Israel (A.R., E.M.)
| | | | | | | | | | - Joseph M Massaro
- Department of Biostatistics and Epidemiology, Boston University School of Public Health, MA (J.M.M.)
| | - Hector M Garcia-Garcia
- Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, DC (H.M.G.-G., R.W.)
| | - Johan Bennett
- Department of Cardiovascular Medicine, University Hospitals Leuven, Belgium (J.B.)
| | | | - Donald E Cutlip
- Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, MA (D.E.C.)
| | - Ron Waksman
- Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, DC (H.M.G.-G., R.W.)
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38
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Verdoia M, Kedhi E, Suryapranata H, Galasso G, Dudek D, De Luca G. Polymer-Free vs. Polymer-Coated Drug-Eluting Stents for the Treatment of Coronary Artery Disease: A Meta-Analysis of 16 Randomized Trials. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2019; 21:745-753. [PMID: 31669109 DOI: 10.1016/j.carrev.2019.10.017] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2019] [Revised: 09/30/2019] [Accepted: 10/14/2019] [Indexed: 01/10/2023]
Abstract
BACKGROUND Polymer-coating represents one of components of drug-eluting stents (DES) to have experienced a more intensive technological evolution. Polymer-free DES (PF-DES) have offered promising angiographic results, with earlier complete re-endothelization, potentially reducing the thrombotic risk and offering the option of a shorter antiplatelet therapy. However, contrasting prognostic data have been reported so far with PF-DES. Therefore, the aim of the present study was to perform a comprehensive updated meta-analysis of randomized trials (RCT) comparing the impact of PF-DES vs polymer- coated DES (PC-DES) on clinical outcome. METHODS Literature and main scientific session abstracts were searched for RCTs comparing PF-DES vs PC-DES for the treatment of CAD. The primary efficacy endpoint was mortality, secondary endpoints were cardiovascular death, myocardial infarction, target lesion revascularization (TLR) and stent thrombosis. RESULTS We included 16 randomized clinical trials, with a total of 15,689 patients, including 50.6% randomized to PF-DES. At a median follow-up of 24 months, PF-DES were associated to a significant reduction in mortality as compared to PC-DES (0.82 [0.68, 0.99], p = .03, I2 = 0%; phet = 0.93). However, no significant benefit was observed in terms of cardiovascular death or major ischemic endpoints (respectively CV death: OR [95% CI] = 0.92 [0.71, 1.18] p = .50, I2 = 0.50; phet = 0.84; MI: OR [95% CI] = 1.08 [0.90, 1.29], p = .42; I2 = 0%, phet = 0.98; TLR: OR [95% CI] = 1.02 [0.78, 1.32], p = .91; I2 = 0.63 phet = 0.0003; ST: OR [95% CI] = 0.98 [0.87, 1.10], p = .72; I2 = 0% phet = 0.64). By meta-regression analysis, the mortality benefits of PF-DES were not conditioned by the rate of diabetes mellitus or acute coronary syndromes. CONCLUSIONS Based on the current meta-analysis, PF-DES are associated to a significant reduction in mortality as compared to PC-DES, but not in the occurrence of major ischemic events. Future larger studies are certainly needed to further investigate and confirm our findings, especially in particular subsets of patients, such as those with high bleeding risk or acute myocardial infarction.
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Affiliation(s)
- Monica Verdoia
- Division of Cardiology, Azienda Ospedaliera-Universitaria "Maggiore della Carità", Eastern Piedmont University, Novara, Italy
| | - Elvin Kedhi
- Department of Cardiology, ISALA Hospital, Zwolle, the Netherlands
| | | | - Gennaro Galasso
- Divisione di Cardiologia, Università degli Studi di Salerno, Italy
| | - Dariusz Dudek
- Department of Interventional Cardiology, Jagellonian University Krakow, Poland
| | - Giuseppe De Luca
- Division of Cardiology, Azienda Ospedaliera-Universitaria "Maggiore della Carità", Eastern Piedmont University, Novara, Italy.
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39
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Major ischaemic and bleeding risks following current drug-eluting stent implantation: Are there differences across current drug-eluting stent types in real life? Arch Cardiovasc Dis 2019; 112:469-484. [DOI: 10.1016/j.acvd.2019.04.007] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2019] [Revised: 03/14/2019] [Accepted: 04/02/2019] [Indexed: 02/07/2023]
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40
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Yamawaki M, Muramatsu T, Ashida K, Kishi K, Morino Y, Kinoshita Y, Fujii T, Noguchi Y, Hosogi S, Kawai K, Hibi K, Shibata Y, Ohira H, Morita Y, Tarutani Y, Toda M, Shimada Y, Ikari Y, Ando J, Hikichi Y, Otsuka Y, Fuku Y, Ito S, Katoh H, Kadota K, Ito Y, Mitsudo K. Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial. Heart Vessels 2019; 34:1297-1308. [PMID: 30859377 DOI: 10.1007/s00380-019-01368-3] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/30/2018] [Accepted: 03/01/2019] [Indexed: 11/25/2022]
Abstract
The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.
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Affiliation(s)
- Masahiro Yamawaki
- Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi Tsurumi, Yokohama, 230-8765, Japan.
| | | | - Kazuhiro Ashida
- Department of Cardiology, Yokohama Shintoshi Neurosurgery Hospital, Yokohama, Japan
| | - Koichi Kishi
- Department of Cardiology, Tokushima Red Cross Hospital, Komatsushima, Japan
| | - Yoshihiro Morino
- Department of Cardiology, Iwate Medical University Hospital, Morioka, Japan
| | | | - Takashi Fujii
- Department of Cardiology, Ako City Hospital, Ako, Japan
| | - Yuichi Noguchi
- Department of Cardiology, Tsukuba Medical Center, Tsukuba, Japan
| | - Shingo Hosogi
- Department of Cardiology, Kochi Medical Center, Kochi, Japan
| | - Kazuya Kawai
- Department of Cardiology, Chikamori Hospital, Kochi, Japan
| | - Kiyoshi Hibi
- Department of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
| | - Yoshisato Shibata
- Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan
| | - Hiroshi Ohira
- Department of Cardiology, Edogawa Hospital, Tokyo, Japan
| | | | - Yasuhiro Tarutani
- Department of Cardiology, Okamura Memorial Hopsital, Shimizu-cho, Japan
| | - Mikihito Toda
- Department of Cardiology, Toho University Oomori Hospital, Tokyo, Japan
| | | | - Yuji Ikari
- Department of Cardiology, Tokai University Hospital, Isehara, Japan
| | - Jiro Ando
- Department of Cardiology, Tokyo University Hospital, Tokyo, Japan
| | - Yutaka Hikichi
- Department of Cardiology, Saga University Hospital, Saga, Japan
| | - Yoritaka Otsuka
- Department of Cardiology, Fukuoka Wajiro Hospital, Fukuoka, Japan
| | - Yasushi Fuku
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Shigenori Ito
- Department of Cardiology, Sankuro Hospital, Toyota, Japan
| | - Harumi Katoh
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Kazushige Kadota
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Yoshiaki Ito
- Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi Tsurumi, Yokohama, 230-8765, Japan
| | - Kazuaki Mitsudo
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
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41
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Kim CH, Park KW, Kang J, Park BE, Cha KS, Rhew JY, Jeon HK, Shin ES, Oh JH, Jeong MH, Kim S, Hwang KK, Yoon JH, Lee SY, Park TH, Moon KW, Kwon HM, Hur SH, Ryu JK, Lee BR, Park YW, Chae IH, Kim HS. Long-Term Comparison of Platinum Chromium Everolimus-Eluting Stent vs. Cobalt Chromium Zotarolimus-Eluting Stent - 3-Year Outcomes From the HOST-ASSURE Randomized Clinical Trial. Circ J 2019; 83:1489-1497. [PMID: 31155604 DOI: 10.1253/circj.cj-18-1303] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
BACKGROUND There are limited data on the long-term outcome of platinum chromium-based everolimus-eluting stents (PtCr-EES) vs. cobalt chromium-based zotarolimus-eluting stents (CoCr-ZES). METHODS AND RESULTS A total of 3,755 patients undergoing percutaneous coronary intervention (PCI) were randomized 2:1 to PtCr-EES or CoCr-ZES, and 96.0% of patients completed the 3-year clinical follow-up. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR). At 3 years, TLF occurred in 5.3% and in 5.4% of the PtCr-EES and CoCr-ZES groups, respectively (hazard ratio 0.978; 95% confidence interval 0.730-1.310, P=0.919). There were no significant differences in the individual components of TLF. Routine angiographic follow-up was performed in 38.9% of the total patients. In a landmark analysis of the subgroup that had follow-up angiography, the clinically-driven TLR rate of CoCr-ZES was significantly higher than PtCr-EES group during the angiography follow-up period (P=0.009). Overall definite and probable stent thrombosis rates were very low in both groups (0.5% vs. 0.6%, P=0.677). CONCLUSIONS PtCr-EES and CoCr-ZES had similar and excellent long-term outcomes in both efficacy and safety after PCI in an all-comer population.
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Affiliation(s)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | - In-Ho Chae
- Seoul National University Bundang Hospital
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42
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Takamura S, Suzuki N, Ishibashi R, Yukimitsu N, Sasaki K, Terada Y, Kawashima H, Kyono H, Kozuma K. Long-Term Clinical and Angiographic Outcomes After Implantation of New-Generation Drug-Eluting Stents for Patients on Maintenance Hemodialysis. Int Heart J 2019; 60:521-526. [PMID: 31105145 DOI: 10.1536/ihj.18-359] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
Prior research has revealed poorer clinical outcomes after drug-eluting stent (DES) implantation for hemodialysis patients. This study aims to investigate the long-term clinical and angiographic outcomes after new-generation DES implantation for hemodialysis patients.We retrospectively enrolled 91 consecutive patients (118 lesions) who underwent successful new-generation DES (everolimus-, zotarolimus-, and biolimus-eluting stents) implantation for the first time. We measured the serum calcium and phosphorus levels in the blood samples obtained just before hemodialysis. The follow-up period of clinical events was, at least, 1.5 years. In this study, major adverse cardiac and cerebrovascular events (MACCE) and clinically driven target lesion revascularization were reported in 36 (39.6%) and 11 (12.1%) patients, respectively. The prevalence of peripheral artery disease was significantly higher in the MACCE group (41.7% versus 14.5%, P = 0.006). The serum calcium level was significantly higher in the MACCE group (9.34 ± 0.92 mg/dL versus 8.77 ± 0.88 mg/dL; P = 0.004). The multivariate Cox proportional hazards model revealed that the serum calcium level (hazard ratio, 1.86; 95% confidence interval [CI]: 1.26-2.77; P = 0.002), suboptimal (over 55 mg2/dL2) calcium-phosphorus product (hazard ratio, 3.27; 95% CI: 1.41-7.61; P = 0.006) and the coexistence of peripheral artery disease (hazard ratio, 3.15; 95% CI: 1.49-6.65; P = 0.003) were independent predictors of MACCE.For hemodialysis patients, MACCE remains a frequent occurrence after new-generation DES implantation and is associated with calcium-phosphate metabolism and peripheral artery disease.
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Affiliation(s)
| | - Nobuaki Suzuki
- Fourth Department of Internal Medicine, Teikyo University School of Medicine
| | - Ruri Ishibashi
- Department of Medicine, Teikyo University School of Medicine
| | | | - Kazuya Sasaki
- Department of Medicine, Teikyo University School of Medicine
| | - Yukiko Terada
- Department of Medicine, Teikyo University School of Medicine
| | | | - Hiroyuki Kyono
- Department of Medicine, Teikyo University School of Medicine
| | - Ken Kozuma
- Department of Medicine, Teikyo University School of Medicine
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43
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Mridha N, Subhaharan D, Niranjan S, Rashid MK, Psaltis P, Singh K. A meta-analysis of randomized controlled trials to compare long-term clinical outcomes of bioabsorbable polymer and durable polymer drug-eluting stents. EUROPEAN HEART JOURNAL. QUALITY OF CARE & CLINICAL OUTCOMES 2019; 5:105-113. [PMID: 30032294 DOI: 10.1093/ehjqcco/qcy036] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/21/2018] [Revised: 07/13/2018] [Accepted: 07/18/2018] [Indexed: 11/13/2022]
Abstract
AIMS The durable polymer (DP) of a drug-eluting stent (DES) serves no function once drug elution is complete. To ascertain the benefits of bioabsorbable polymer (BP) over DP-DESs requires a longer follow-up period, to overcome the time taken for polymer absorption. The primary aim of this meta-analysis was to compare the safety and efficacy of BP-DES with the DP-DES over mid (2 years) to long-term (3-5 years) follow-up. METHODS AND RESULTS A thorough computer-based search was performed using Ovid MEDLINE, EMBASE, Google Scholar, and PubMed databases. We only included randomized controlled studies comparing clinical outcomes between BP-DESs and DP-DESs. Only studies where data were available for a minimum of 2 years were included. A separate analysis of 2-year outcomes and 3- to 5-year outcomes were conducted. Data from 6 and 8 studies were included in 3- to 5-year and 2-year follow-up, respectively. There were no differences between stent groups in cardiac mortality, stent thrombosis (ST), target lesion revascularization, target vessel failure, and reinfarction rates for either 2-year or 3- to 5-year follow-up. Subgroup analysis according to strut thickness (<100 µm, >100 µm) of BP-DES demonstrated similar results. The analyses of ST and very late ST favoured BP-DESs but did not reach statistically significant level. CONCLUSION There were no differences in clinical outcomes between BP-DESs and DP-DESs over mid- and long-term follow-up.
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Affiliation(s)
- Naim Mridha
- Department of Cardiology, Gold Coast University Hospital, 1 Hospital Blvd Southport, QLD, Australia.,Department of Medicine, Griffith University, Parklands Dr, Southport, QLD, Australia.,School of medicine, Bond University, 14 University Dr, Robina, QLD, Australia
| | - Deloshaan Subhaharan
- Department of Cardiology, Gold Coast University Hospital, 1 Hospital Blvd Southport, QLD, Australia.,School of medicine, Bond University, 14 University Dr, Robina, QLD, Australia
| | - Selvanayagam Niranjan
- Department of Cardiology, Gold Coast University Hospital, 1 Hospital Blvd Southport, QLD, Australia.,Department of Medicine, Griffith University, Parklands Dr, Southport, QLD, Australia.,School of medicine, Bond University, 14 University Dr, Robina, QLD, Australia
| | - Mohammed K Rashid
- Department of Medicine, Mc Master University, 1280 Main St W, Hamilton, ON, Canada
| | - Peter Psaltis
- Department of medicine, University of Adelaide, North Terrace, Adelaide, SA, Australia.,Department of Medicine, The South Australian Health and Medical Research Institute, North Terrace, Adelaide, SA, Australia
| | - Kuljit Singh
- Department of Cardiology, Gold Coast University Hospital, 1 Hospital Blvd Southport, QLD, Australia.,Department of Medicine, Griffith University, Parklands Dr, Southport, QLD, Australia.,School of medicine, Bond University, 14 University Dr, Robina, QLD, Australia.,Department of medicine, University of Adelaide, North Terrace, Adelaide, SA, Australia
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44
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Colombo A, Chandrasekhar J, Aquino M, Ong TK, Sartori S, Baber U, Lee M, Iniguez A, Hajek P, Borisov B, Atzev B, Den Heijer P, Coufal Z, Hudec M, Mates M, Snyder C, Moalem K, Morrell D, Elmore F, Rowland S, Mehran R. Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry. Int J Cardiol 2019; 283:67-72. [DOI: 10.1016/j.ijcard.2019.01.053] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/19/2018] [Revised: 11/18/2018] [Accepted: 01/14/2019] [Indexed: 11/28/2022]
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45
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Kang SH, Gogas BD, Jeon KH, Park JS, Lee W, Yoon CH, Suh JW, Hwang SS, Youn TJ, Chae IH, Kim HS. Long-term safety of bioresorbable scaffolds: insights from a network meta-analysis including 91 trials. EUROINTERVENTION 2019; 13:1904-1913. [PMID: 29278353 DOI: 10.4244/eij-d-17-00646] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
AIMS The aim of this study was to investigate the long-term safety and efficacy of biodegradable scaffolds and metallic stents. METHODS AND RESULTS We analysed a total of 91 randomised controlled trials with a mean follow-up of 3.7 years in 105,842 patients which compared two or more coronary metallic stents or biodegradable scaffolds and reported the long-term clinical outcomes (≥2 years). Network meta-analysis showed that patients treated with the Absorb bioresorbable vascular scaffold (BVS) had a significantly higher risk of definite or probable scaffold thrombosis (ScT) compared to those treated with metallic DES. The risk of very late ScT was highest with the Absorb BVS among comparators. Pairwise conventional meta-analysis demonstrated that the elevated risk of ScT with Absorb BVS compared to cobalt-chromium everolimus-eluting stents was consistent across the time points of ≤30 days (early), 31 days - 1 year (late) and >1 year (very late) ScT. In addition, target lesion failure rates were significantly higher in the Absorb BVS cohort, driven by both increased risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularisation. CONCLUSIONS Absorb BVS implantation was associated with increased risk of long-term and very late ScT compared to current-generation metallic DES. The risk of ScT occurred with a rising trend beyond one year.
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Affiliation(s)
- Si-Hyuck Kang
- Division of Cardiology, Department of Internal Medicine, College of Medicine, Seoul National University and Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea
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46
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Lee BK, Kim JS, Lee OH, Min PK, Yoon YW, Hong BK, Shin DH, Kang TS, Kim BO, Cho DK, Jeon DW, Woo SI, Choi S, Kim YH, Kang WC, Kim S, Kim BK, Hong MK, Jang Y, Kwon HM. Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy. EUROINTERVENTION 2019; 13:1923-1930. [PMID: 29104179 DOI: 10.4244/eij-d-17-00792] [Citation(s) in RCA: 39] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
AIMS There are few randomised studies concerning the optimal duration of dual antiplatelet therapy (DAPT) for patients who receive a second-generation drug-eluting stent (DES). This trial aimed to investigate the safety of six-month compared with 12-month DAPT maintenance after second-generation DES implantation. METHODS AND RESULTS A prospective, randomised, multicentre trial was performed at 10 medical centres. The 1,368 patients included in the study received a biolimus-eluting stent (BES) or a zotarolimus-eluting stent (ZES). The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up. The secondary outcome was the percentage of uncovered struts at six months in 60 patients (30 ZES, 30 BES) using optical coherence tomography (OCT) assessment. Each patient was randomly assigned to six-month (n=684) or 12-month DAPT (n=684). Major adverse cardiac events at 12 months occurred in eight patients (1.2%) in the six-month DAPT group and in four patients (0.6%) in the 12-month DAPT group (risk difference 0.6%; 95% confidence interval [CI]: -0.4-1.6%; p=0.24). The upper 95% CI limit was lower than the pre-specified limit of 4% non-inferiority (p for non-inferiority <0.05). The percentage of uncovered struts was 3.16±4.30% at six months in 60 stents of 60 patients. CONCLUSIONS After second-generation DES implantation, six-month DAPT was not inferior to 12-month DAPT in terms of MACE occurrence over the 12-month follow-up period. OCT examination revealed favourable stent strut coverage at six months after stent implantation.
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Affiliation(s)
- Byoung-Kwon Lee
- Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
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47
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Valdes-Chavarri M, Kedev S, Neskovic AN, Morís de la Tassa C, Zivkovic M, Trillo Nouche R, Vázquez González N, Bartorelli AL, Antoniucci D, Tamburino C, Colombo A, Abizaid AA, McFadden E, Garcia-Garcia HM, Milasinovic D, Stankovic G. Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study. EUROINTERVENTION 2019; 14:e1836-e1842. [PMID: 29957593 DOI: 10.4244/eij-d-17-01087] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
AIMS The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). CONCLUSIONS The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.
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48
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Tabata N, Sueta D, Yamamoto E, Takashio S, Arima Y, Araki S, Yamanaga K, Ishii M, Sakamoto K, Kanazawa H, Fujisue K, Hanatani S, Soejima H, Hokimoto S, Izumiya Y, Kojima S, Yamabe H, Kaikita K, Matsui K, Tsujita K. A retrospective study of arterial stiffness and subsequent clinical outcomes in cancer patients undergoing percutaneous coronary intervention. J Hypertens 2019; 37:754-764. [PMID: 30817457 DOI: 10.1097/hjh.0000000000001949] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE Increasing attention is being paid to the relationship between cancer and cardiovascular diseases. In this study, we examined arterial stenosis and stiffness in patients with malignant diseases requiring percutaneous coronary intervention. METHODS This was a retrospective, single-center, observational study. Participants (n = 1003) were divided into a malignant group, with current or past malignant disease, and a nonmalignant group. The ankle-brachial index (ABI) and brachial-ankle pulse wave velocity (baPWV) were evaluated. The endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, stroke, and revascularization within 1 year. RESULTS We observed significantly impaired ABI and baPWV in the malignant group. A total of 148 patients had a cardiovascular event. Kaplan-Meier analysis showed a significantly higher probability of cardiovascular events in the malignant group (P = 0.012). The combination of malignancy with ABI/baPWV identified subgroups with significantly different probabilities of cardiovascular events. Multivariate Cox hazard analysis identified malignancy as an independent predictor of cardiovascular events (hazard ratio, 1.54; 95% confidence interval, 1.06-2.26; P = 0.025) with an increased hazard ratio by adding the status of low ABI/high baPWV to malignancy (hazard ratio, 2.36; 95% confidence interval, 1.35-4.12; P = 0.003). We found significantly higher follow-up baPWV values in the malignancy group (P = 0.016). CONCLUSION Atherosclerosis is advanced and accelerated in patients with malignancy, and these patients had significantly higher rates of adverse cardiovascular events, and their risk might be stratified by ABI and baPWV. REGISTRATION University Hospital Medical Information Network-CTR (http://www.umin.ac.jp/ctr/). IDENTIFIER Kumamoto University Malignancy and Atherosclerosis study (UMIN000028652). PUBLIC ACCESS INFORMATION Opt-out materials are available at the following website: http://www.kumadai-junnai.com/home/wp-content/uploads/akusei.pdf.
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Affiliation(s)
- Noriaki Tabata
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Daisuke Sueta
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Eiichiro Yamamoto
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Seiji Takashio
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Yuichiro Arima
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Satoshi Araki
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Kenshi Yamanaga
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Masanobu Ishii
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Kenji Sakamoto
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Hisanori Kanazawa
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Koichiro Fujisue
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Shinsuke Hanatani
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Hirofumi Soejima
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Seiji Hokimoto
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Yasuhiro Izumiya
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Sunao Kojima
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Hiroshige Yamabe
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Koichi Kaikita
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
| | - Kunihiko Matsui
- Department of Community, Family, and General Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan
| | - Kenichi Tsujita
- Department of Cardiovascular Medicine
- Center for Metabolic Regulation of Healthy Aging
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49
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Suzuki S, Sotomi Y, Kobayashi T, Hamanaka Y, Nakatani S, Shiojima I, Sakata Y, Hirayama A, Higuchi Y. Early vessel healing after implantation of biodegradable-polymer and durable-polymer drug-eluting stent: 3-month angioscopic evaluation of the RESTORE registry. Int J Cardiovasc Imaging 2019; 35:973-980. [PMID: 30874980 DOI: 10.1007/s10554-019-01580-2] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/27/2018] [Accepted: 03/07/2019] [Indexed: 10/27/2022]
Abstract
The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results.
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Affiliation(s)
- Satoshi Suzuki
- Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan
| | - Yohei Sotomi
- Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan.
| | - Tomoaki Kobayashi
- Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan
| | - Yuma Hamanaka
- Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan
| | - Shimpei Nakatani
- Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan
| | - Ichiro Shiojima
- Department of Medicine II, Kansai Medical University, Hirakata, Japan
| | - Yasushi Sakata
- Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan
| | - Atsushi Hirayama
- Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan
| | - Yoshiharu Higuchi
- Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan
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50
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Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferović PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. EUROINTERVENTION 2019; 14:1435-1534. [PMID: 30667361 DOI: 10.4244/eijy19m01_01] [Citation(s) in RCA: 372] [Impact Index Per Article: 62.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/25/2023]
Affiliation(s)
- Franz-Josef Neumann
- Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany
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