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Saito S, Bennett J, Nef HM, Webster M, Namiki A, Takahashi A, Kakuta T, Yamazaki S, Shibata Y, Scott D, Vrolix M, Menon M, Möllmann H, Werner N, Neylon A, Mehmedbegovic Z, Smits PC, Morice MC, Verheye S. Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent: 2-Year Outcomes From BIOADAPTOR RCT. JACC Cardiovasc Interv 2025; 18:988-997. [PMID: 40057888 DOI: 10.1016/j.jcin.2025.01.426] [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: 07/31/2024] [Revised: 01/02/2025] [Accepted: 01/14/2025] [Indexed: 05/02/2025]
Abstract
BACKGROUND The sirolimus-eluting bioadaptor is a novel coronary implant that unlocks, separates, and maintains dynamic support of the vessel at the lesion site 6 months after percutaneous coronary intervention when the polymer coating covering the helical strands resorbs. This enables the bioadaptor to maintain the established flow lumen and to restore hemodynamic modulation of the artery, including cyclic pulsatility, vasomotion, and adaptive remodeling. OBJECTIVES The purpose of this study was to report the first randomized clinical evidence of the DynamX bioadaptor implant through 2 years compared with the Resolute Onyx contemporary drug-eluting stent. METHODS This multicenter, single-blind, 1:1 randomized clinical trial was conducted at 34 hospitals in Japan, Europe, and New Zealand. The eligibility criterion was de novo coronary lesions in up to 2 vessels. The sample size was based on the primary endpoint, noninferiority of 12-month target lesion failure (TLF). The authors herein report 2-year outcomes. RESULTS In total, 445 patients were enrolled; 3 patients treated for in-stent restenosis and 2 who did not receive the assigned study device because of randomization error were excluded from the analysis. In the per-protocol population of patients with de novo native coronary lesions treated with the assigned device (n = 440), 2-year Kaplan-Meier estimates of TLF and target vessel failure rates in the bioadaptor group were lower (1.8% [4 of 219] vs 5.5% [12 of 221], risk difference -3.6% [95% CI: -7.8% to -0.0%; P = 0.044], and 1.8% [4 of 219] vs 5.9% (13 of 221), risk difference -4.1% [95% CI: -7.2% to -1.0%; P = 0.027], respectively). One clinically driven target lesion revascularization occurred between 6 months and 2 years in the bioadaptor group, whereas 2 cardiovascular deaths and 4 clinically driven target lesion revascularizations occurred in the drug-eluting stent group. The 2-year rate of definite or probable device thrombosis was 0.0% vs 0.5% (n = 1) (P = 0.32), respectively. CONCLUSIONS This is the first report of 2-year outcomes comparing the bioadaptor implant with a contemporary drug-eluting stent. At 2-year follow-up, fewer TLF events were observed in patients treated with the bioadaptor. (The Elixir Bioadaptor vs. the Onyx Stent in De Novo Native Coronary Arteries [BIOADAPTOR RCT]; NCT04192747).
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Affiliation(s)
- Shigeru Saito
- Heart Center, Iryohojin Tokushukai Shonan Kamakura General Hospital, Kamakura City, Japan.
| | - Johan Bennett
- Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium
| | - Holger M Nef
- Department of Cardiology and Angiology, University of Giessen, Giessen, Germany
| | - Mark Webster
- Cardiac Investigation Unit, Auckland City Hospital, Auckland, New Zealand
| | - Atsuo Namiki
- Department of Cardiology, Kanto Rosai Hospital, Nakahara-ku, Kawasaki-shi, Japan
| | | | - Tsunekazu Kakuta
- Cardiovascular Medicine, Tsuchiura Kyodo Hospital, Tsuchiura City, Japan
| | - Seiji Yamazaki
- Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan
| | - Yoshisato Shibata
- Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki City, Japan
| | - Douglas Scott
- Department of Cardiology, Middlemore Hospital, Auckland, New Zealand
| | - Mathias Vrolix
- Department of Cardiology, Ziekenhuis Oost-Limburg, Campus Sint Jan, Genk, Belgium
| | - Madhav Menon
- Department of Cardiology, Waikato Hospital, Hamilton, New Zealand
| | - Helge Möllmann
- Department of Cardiology, St. Johannes Hospital Dortmund, Dortmund, Germany
| | - Nikos Werner
- Department of Cardiology, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany
| | | | | | - Pieter C Smits
- Cardiovascular European Research Center ICPS Ramsay, Massy, France
| | | | - Stefan Verheye
- Interventional Cardiology, ZAS Cardiovascular Center Middelheim, Antwerp, Belgium
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Vanoverbeke L, Bennett J. Drug-eluting resorbable coronary scaffolds: a review of recent advances. Expert Opin Drug Deliv 2025:1-15. [PMID: 40238640 DOI: 10.1080/17425247.2025.2495043] [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: 01/27/2025] [Revised: 03/10/2025] [Accepted: 04/15/2025] [Indexed: 04/18/2025]
Abstract
INTRODUCTION Device-related persistent adverse events with current DES-use have refocused the attention on a 'leave-nothing-behind' philosophy, in which it is hypothesized that treating coronary stenosis without permanently caging the vessel with a metallic implant would lead to superior clinical outcomes. One of these uncaging technologies is bioresorbable scaffolds (BRS). AREAS COVERED In this article, we describe the technical specifications and clinical data of currently available BRS devices. EXPERT OPINION Newer BRS devices have thinner struts and more biocompatible scaffold backbones (either polymer-based or metal-based), resulting in improved radial strength, faster resorption times, and more antithrombogenic properties (e.g. magnesium-based scaffolds). Results of BRS in the treatment of simple coronary artery disease demonstrate favorable clinical efficacy and safety outcome data. It is probable that over the next 5 years more fourth-generation devices with ever-increasing biocompatibility and safety profiles will be investigated and released commercially, resulting in a much more prominent role for BRS, especially in the treatment of simple coronary artery disease in younger patients.
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Affiliation(s)
- Lowie Vanoverbeke
- Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
| | - Johan Bennett
- Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
- Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium
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Seguchi M, Sakakura K, Taniguchi Y, Fujita H. Current situation and overview of resorbable magnesium scaffolds: a perspective for overcoming the remaining issues of polymeric bioresorbable scaffold. Cardiovasc Interv Ther 2025; 40:245-254. [PMID: 39707057 DOI: 10.1007/s12928-024-01070-w] [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: 11/24/2024] [Accepted: 11/25/2024] [Indexed: 12/23/2024]
Abstract
Bioresorbable scaffolds (BRS) were developed as an innovative solution to overcome the limitations of metallic stents. While polymeric BRS initially demonstrated comparable clinical outcomes to drug-eluting stent (DES) in clinical trials, subsequent large-scale studies revealed that patients implanted with polymeric BRS experienced higher rates of scaffold thrombosis (ScT) and target lesion failure compared to those with metallic stents. Resorbable magnesium scaffolds (RMS) have emerged as a promising alternative owing to magnesium's natural degradability and favorable mechanical properties. Learning from the mechanism of polymeric BRS failure and through continuous improvements, recent clinical trials have shown promising clinical performance for RMS technology. However, comparative studies between RMS and DES have continued to highlight the remaining challenges with RMS, particularly in regard to late lumen loss. Recent advancements in third-generation RMS show improvements in strut thickness and homogeneous degradation, which enhances sustained structural integrity throughout the degradation process. Based on encouraging results from a first-in-human trial of the latest version of RMS, a randomized controlled trial has been initiated to compare the outcomes between metallic stents and the latest RMS, with patient enrollment already underway. This review aims to explore the limitations of polymeric BRS and provide an overview of the current developments and future potential of magnesium-based BRS.
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Affiliation(s)
- Masaru Seguchi
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya-ku, Saitama, Saitama, 330-8503, Japan.
| | - Kenichi Sakakura
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya-ku, Saitama, Saitama, 330-8503, Japan
| | - Yousuke Taniguchi
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya-ku, Saitama, Saitama, 330-8503, Japan
| | - Hideo Fujita
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya-ku, Saitama, Saitama, 330-8503, Japan
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Dinc R, Ekingen E. Biodegradable Stents in the Treatment of Arterial Stenosis. J Clin Med 2025; 14:532. [PMID: 39860538 PMCID: PMC11765601 DOI: 10.3390/jcm14020532] [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: 11/08/2024] [Revised: 12/20/2024] [Accepted: 01/12/2025] [Indexed: 01/27/2025] Open
Abstract
Arterial diseases (ADs) are a significant health problem, with high mortality and morbidity rates. Endovascular interventions, such as balloon angioplasty (BA), bare-metal stents (BMSs), drug-eluting stents (DESs) and drug-coated balloons (DCBs), have made significant progress in their treatments. However, the issue has not been fully resolved, with restenosis remaining a major concern. In this context, bioresorbable vascular stents (BVSs) have emerged as a promising area of investigation. This manuscript includes articles that assess the use of BVSs. Studies have identified ongoing challenges, such as negative vascular remodeling and elastic recoil post-angioplasty, stent-related injury, and in-stent restenosis following BMS placement. While DESs have mitigated these issues to a considerable extent, their durable structures are unable to prevent late stent thrombosis and delay arterial recovery. BVSs, with their lower support strength and tendency towards thicker scaffolds, increase the risk of scaffold thrombosis. Despite inconsistent study results, the superiority of BVSs over DESs has not been demonstrated in randomized trials, and DES devices continue to be the preferred choice for most cases of arterial disease. Esprit BTK (Abbott Vascular) received approval from the US FDA for below-knee lesions in 2024, offering hope for the use of BVSs in other vascular conditions. Enhancing the design and thickness of BVS scaffolds may open up new possibilities. Large-scale and longer-term comparative studies are still required. This article aims to provide an overview of the use of biodegradable stents in the endovascular treatment of vascular stenosis.
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Affiliation(s)
- Rasit Dinc
- INVAMED Medical Innovation Institute, New York, NY 10007, USA
| | - Evren Ekingen
- Department of Accident and Emergency, Etlik City Hospital, Ankara 06170, Turkey;
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Power DA, Camaj A, Kereiakes DJ, Ellis SG, Gao R, Kimura T, Ali ZA, Stockelman KA, Dressler O, Onuma Y, Serruys PW, Stone GW. Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program. JACC Cardiovasc Interv 2025; 18:1-11. [PMID: 39814482 DOI: 10.1016/j.jcin.2024.08.050] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/10/2024] [Revised: 08/19/2024] [Accepted: 08/27/2024] [Indexed: 01/18/2025]
Abstract
BACKGROUND The risk-benefit ratio of the Absorb bioresorbable vascular scaffold (BVS) may vary before and after 3 years, the time point of complete bioresorption of the poly-L-lactic acid scaffold. OBJECTIVES The aim of this study was to determine the time-varying outcomes of the Absorb BVS compared with cobalt-chromium everolimus-eluting stents (EES) from a large individual-patient-data pooled analysis of randomized trials. METHODS The individual patient data from 5 trials that randomized 5,988 patients undergoing percutaneous coronary intervention to the Absorb BVS vs EES with 5-year follow-up were pooled. The primary effectiveness and safety endpoints were target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis (DT). RESULTS Between 0 and 5 years, TLF occurred in 15.9% BVS patients vs 13.1% EES patients (HR: 1.25; 95% CI: 1.08-1.43; P = 0.002), and DT occurred in 2.2% vs 1.0%, respectively (HR: 2.38; 95% CI: 1.49-3.79; P = 0.0002). Between 0 and 3 years, TLF occurred in 12.4% BVS patients vs 9.3% EES patients (HR: 1.35; 95% CI: 1.15-1.59; P = 0.0002), and DT occurred in 2.0% vs 0.6%, respectively (HR: 3.58; 95% CI: 2.01-6.36; P < 0.0001). Between 3 and 5 years, TLF occurred in 4.5% BVS patients vs 4.7% EES patients (HR: 0.99; 95% CI: 0.76-1.27; P = 0.91), and DT occurred in 0.2% vs 0.4%, respectively (HR: 0.49; 95% CI: 0.18-1.38; P = 0.17). By spline analysis, the TLF hazard by 5 years was lower with BVS than EES. CONCLUSIONS Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years, when poly-L-lactic acid bioresorption is complete. Thereafter event rates were comparable or lower with BVS. (ABSORB II Randomized Controlled Trial, NCT01425281; A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold [Absorb™ BVS] System in Chinese Population - ABSORB CHINA Randomized Controlled Trial [ABSORB CHINA], NCT01923740; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN], NCT01844284; ABSORB III Randomized Controlled Trial [ABSORB III], NCT01751906; Absorb IV Randomized Controlled Trial, NCT02173379).
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Affiliation(s)
- David A Power
- Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Anton Camaj
- Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Dean J Kereiakes
- The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, Ohio
| | | | - Runlin Gao
- Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
| | | | - Ziad A Ali
- St. Francis Hospital, Roslyn, New York, USA; Cardiovascular Research Foundation, New York, New York
| | | | | | - Yoshinobu Onuma
- CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland
| | - Patrick W Serruys
- CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland
| | - Gregg W Stone
- Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
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Erlinge D, Andersson J, Fröbert O, Törnerud M, Böhm F, Held C, Elek C, Sirhan M, Oldgren J, James S. Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent. Am Heart J 2024; 277:1-10. [PMID: 39098754 DOI: 10.1016/j.ahj.2024.07.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2024] [Revised: 07/06/2024] [Accepted: 07/27/2024] [Indexed: 08/06/2024]
Abstract
BACKGROUND Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI). METHODS The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients. SUMMARY The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.
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Affiliation(s)
- David Erlinge
- Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.
| | | | - Ole Fröbert
- Örebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden; Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark
| | - Mattias Törnerud
- Department of Cardiology, Karolinska Institute and Danderyd Hospital, Stockholm, Sweden
| | - Felix Böhm
- Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
| | - Claes Held
- Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Sweden
| | | | | | - Jonas Oldgren
- Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Sweden
| | - Stefan James
- Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Sweden
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Bengueddache S, Cook M, Lehmann S, Arroyo D, Togni M, Puricel S, Cook S. Ten-year clinical outcomes of everolimus- and biolimus-eluting coronary stents vs. everolimus-eluting bioresorbable vascular scaffolds-insights from the EVERBIO-2 trial. Front Cardiovasc Med 2024; 11:1426348. [PMID: 39323753 PMCID: PMC11423422 DOI: 10.3389/fcvm.2024.1426348] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/01/2024] [Accepted: 08/22/2024] [Indexed: 09/27/2024] Open
Abstract
Background Bioresorbable vascular scaffolds (BVSs) have been developed as a potential solution to mitigate late complications associated with drug-eluting metallic stents (DESs) in percutaneous coronary intervention for coronary artery disease. While numerous studies have compared BVSs to DESs, none have assessed clinical outcomes beyond 5 years. Objectives This study aimed to compare the 10-year clinical outcomes of patients treated with BVSs vs. DESs. Methods The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) is a single-center, assessor-blinded, randomized controlled trial that enrolled 240 patients allocated in a 1:1:1 ratio to receive BVSs, everolimus-eluting stents, or biolimus-eluting stents (BESs). Clinical follow-up was scheduled for 10 years. Results Clinical follow-up was completed in 222 patients (93%) at the 10-year mark. The rate of device-oriented composite events (DOCE) was 28% in the DES group and 29% in the BVS group (p = 0.72) at 10 years. Similarly, the rate of patient-oriented composite events (POCE) was 55% in the DES group and 49% in the BVS group (p = 0.43) at 10 years. Notably, the rate of myocardial infarction (MI) within the target vessel was 5% in the BVS group and 0% in the BES group (p = 0.04), while the rate of any MI was 10% in the BVS group and 2% in the BES group (p = 0.04). In addition, the rate of Academic Research Consortium (ARC) possible stent thrombosis was 3% in the BVS group and 0% in the DES group (p = 0.04). Conclusions Over 10 years, the rates of clinical DOCE and POCE were similar between the BVS and DES groups but individual outcomes of stent thrombosis were higher (3%) in the BVS group compared to the DES group. Clinical Trial Registration ClinicalTrials.gov, identifier (NCT01711931).
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Affiliation(s)
- Samir Bengueddache
- Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
| | - Malica Cook
- Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
| | - Sonja Lehmann
- Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
| | - Diego Arroyo
- Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
| | - Mario Togni
- Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
| | - Serban Puricel
- Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
| | - Stephane Cook
- Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
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Miyashita K, Ninomiya K, Tobe A, Masuda S, Kotoku N, Kageyama S, Revaiah PC, Tsai TY, Wang B, Garg S, Serruys PW, Onuma Y. Long-term outcomes following bioresorbable vascular scaffolds. Expert Rev Cardiovasc Ther 2024; 22:391-407. [PMID: 39049728 DOI: 10.1080/14779072.2024.2375340] [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: 11/29/2023] [Revised: 02/20/2024] [Accepted: 06/28/2024] [Indexed: 07/27/2024]
Abstract
INTRODUCTION The higher scaffold thrombosis rates observed with the first-generation bioresorbable scaffolds (BRSs) compared to conventional drug-eluting stents were likely due in part to bioresorbable polymers having insufficient radial strength, necessitating larger strut profiles. Meta-analysis of the long-term outcomes from the first-generation Absorb bioresorbable vascular scaffold (BVS) showed that this period of excess risk ended at 3 years. Therefore, current attention has been focused on improving early outcomes by increasing the scaffold's tensile strength and reducing strut thickness. AREAS COVERED This review summaries the lessons learned from the first-generation BRS. It updates the long-term clinical outcomes of trials evaluating the ABSORB BVS and metallic alloy-based BRS. In addition, it reviews the next-generation BRSs manufactured in Asia. EXPERT OPINION Critical areas to improve the performance and safety of biodegradable scaffolds include further development in material science, surface modification, delivery systems, and long-term follow-up studies.
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Affiliation(s)
- Kotaro Miyashita
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Kai Ninomiya
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Akihiro Tobe
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Shinichiro Masuda
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Nozomi Kotoku
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Shigetaka Kageyama
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Pruthvi C Revaiah
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Tsung-Ying Tsai
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Bo Wang
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Scot Garg
- Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK
| | - Patrick W Serruys
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
| | - Yoshinobu Onuma
- The College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
- CORRIB Research Centre for Advanced Imaging and Core laboratory, University of Galway, Galway, Ireland
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Frederiks P, Castaldi G, McCutcheon K, Bennett J. Platinum chromium everolimus-eluting stents for the treatment of (complex) coronary artery disease; from SYNERGY™ to the MEGATRON™. Expert Rev Med Devices 2024; 21:601-611. [PMID: 38720513 DOI: 10.1080/17434440.2024.2353722] [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: 11/18/2023] [Accepted: 05/07/2024] [Indexed: 05/14/2024]
Abstract
INTRODUCTION The introduction of drug-eluting coronary stents (DES) into clinical practice in 2002 represented a major milestone in the treatment of obstructive coronary artery disease. Over the years, significant advances in polymer coating and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation DES. AREAS COVERED Development of platinum chromium (PtCr) alloys with high radial strength and high radiopacity have enabled the design of new, thin-strut, flexible, and highly trackable stent platforms, while simultaneously improving stent visibility. These advances have facilitated complex percutaneous treatment of a diverse population of patients in clinical practice. This review will provide an overview of the evolution in PtCr everolimus-eluting stents from PROMUS Element™ to SYNERGY™ to the recently introduced SYNERGY MEGATRON™. The clinical data will be summarized and put into perspective, especially focusing on the role of the SYNERGY™ and MEGATRON™ platforms in the treatment of complex coronary artery disease and high-risk patients. EXPERT OPINION The SYNERGY™ stent demonstrates favorable clinical efficacy and safety outcome data, and whilst the clinical data on MEGATRON™ are sparse, early experience is promising. The specific overexpansion capabilities, visibility, and radial strength of the MEGATRON™ are attractive features for complex coronary interventions.
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Affiliation(s)
- Pascal Frederiks
- Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
| | - Gianluca Castaldi
- Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
| | - Keir McCutcheon
- Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium
- Department of Cardiology, Lady Pohamba Private Hospital, Windhoek, Namibia
| | - Johan Bennett
- Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
- Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium
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Nakamura M, Suzuki N, Fujii K, Furuya J, Kawasaki T, Kimura T, Sakamoto T, Tanabe K, Kusano H, Stockelman KA, Kozuma K. The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan. Circ J 2024; 88:863-872. [PMID: 38479861 DOI: 10.1253/circj.cj-23-0877] [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] [Indexed: 05/28/2024]
Abstract
BACKGROUND The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available. METHODS AND RESULTS This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. CONCLUSIONS Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.
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Affiliation(s)
- Masato Nakamura
- Division of Minimally Invasive Treatment in Cardiovascular Medicine, Toho University Ohashi Medical Center
| | - Nobuaki Suzuki
- Fourth Department of Internal Medicine, Teikyo University School of Medicine
| | - Kenshi Fujii
- Department of Cardiovascular Medicine, Sakurabashi Watanabe Hospital
| | - Jungo Furuya
- Department of Cardiovascular Medicine, Hanaoka Seishu Memorial Hospital
| | | | - Takumi Kimura
- Department of Cardiovascular Medicine, Iwate Medical University Hospital
| | | | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital
| | | | | | - Ken Kozuma
- Department of Cardiovascular Medicine, Teikyo University Hospital
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11
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Zuccarelli V, Andreaggi S, Walsh JL, Kotronias RA, Chu M, Vibhishanan J, Banning AP, De Maria GL. Treatment and Care of Patients with ST-Segment Elevation Myocardial Infarction-What Challenges Remain after Three Decades of Primary Percutaneous Coronary Intervention? J Clin Med 2024; 13:2923. [PMID: 38792463 PMCID: PMC11122374 DOI: 10.3390/jcm13102923] [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: 04/19/2024] [Revised: 05/11/2024] [Accepted: 05/13/2024] [Indexed: 05/26/2024] Open
Abstract
Primary percutaneous coronary intervention (pPCI) has revolutionized the prognosis of ST-segment elevation myocardial infarction (STEMI) and is the gold standard treatment. As a result of its success, the number of pPCI centres has expanded worldwide. Despite decades of advancements, clinical outcomes in STEMI patients have plateaued. Out-of-hospital cardiac arrest and cardiogenic shock remain a major cause of high in-hospital mortality, whilst the growing burden of heart failure in long-term STEMI survivors presents a growing problem. Many elements aiming to optimize STEMI treatment are still subject to debate or lack sufficient evidence. This review provides an overview of the most contentious current issues in pPCI in STEMI patients, with an emphasis on unresolved questions and persistent challenges.
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Affiliation(s)
- Vittorio Zuccarelli
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
| | - Stefano Andreaggi
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
- Division of Cardiology, Department of Medicine, University of Verona, 37129 Verona, Italy
| | - Jason L. Walsh
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
- Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford OX1 2JD, UK
| | - Rafail A. Kotronias
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
- Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford OX1 2JD, UK
| | - Miao Chu
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
- Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford OX1 2JD, UK
| | - Jonathan Vibhishanan
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
- Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford OX1 2JD, UK
| | - Adrian P. Banning
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
- Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford OX1 2JD, UK
- National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford OX3 9DU, UK
| | - Giovanni Luigi De Maria
- Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK; (V.Z.); (S.A.); (J.L.W.); (R.A.K.); (M.C.); (J.V.); (A.P.B.)
- Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford OX1 2JD, UK
- National Institute for Health Research (NIHR), Oxford Biomedical Research Centre, Oxford OX3 9DU, UK
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12
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Lutz M, Abizaid A, Nielsen Holck E, Lansky A, Carrié D, Weber-Albers J, Dudek D, Frey N, Christiansen EH, Holm NR, Stone GW. Long-term safety and effectiveness of the Fantom bioresorbable coronary artery scaffold: final results of the FANTOM II trial. EUROINTERVENTION 2024; 20:e453-e456. [PMID: 38562069 PMCID: PMC10979385 DOI: 10.4244/eij-d-23-00504] [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: 06/22/2023] [Accepted: 01/02/2024] [Indexed: 04/04/2024]
Affiliation(s)
- Matthias Lutz
- Department of Cardiology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany
| | - Alexandre Abizaid
- Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
- Hospital Israelita Albert Einstein, São Paulo, Brazil
| | - Emil Nielsen Holck
- Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark
| | - Alexandra Lansky
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA
| | - Didier Carrié
- Department of Cardiology, University Hospital Rangueil, Toulouse, France
| | | | - Darius Dudek
- Institute of Cardiology, Jagiellonian University Medical College, University Hospital, Krakow, Poland
| | - Norbert Frey
- Department of Cardiology, University Hospital Heidelberg, Heidelberg, Germany
| | | | - Niels Ramsing Holm
- Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark
| | - Gregg W Stone
- Columbia University Medical Center/NewYork-Presbyterian Hospital, The Cardiovascular Research Foundation, New York, NY, USA
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13
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Kereiakes DJ, Saito S, Nef HM, Webster M, Verheye S, Colombo A. Technology viewpoint: Evolution in PCI: The next major advance in implant technology to restore vessel function. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2024; 61:95-98. [PMID: 37980263 DOI: 10.1016/j.carrev.2023.11.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2023] [Accepted: 11/09/2023] [Indexed: 11/20/2023]
Affiliation(s)
- Dean J Kereiakes
- The Christ Hospital and Lindner Research Center, Cincinnati, OH, United States.
| | - Shigeru Saito
- Heart Center, Iryohojin Tokushukai Shonan Kamakura General Hospital, Kamakura City, Japan
| | - Holger M Nef
- Department of Cardiology and Angiology, University of Giessen, Giessen, Germany
| | - Mark Webster
- Cardiac Investigation Unit, Auckland City Hospital, Auckland, New Zealand
| | - Stefan Verheye
- Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium
| | - Antonio Colombo
- Invasive Cardiology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
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14
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Micari A, Dimartino A, Donato R, Vizzari G, Andò G. Late acquired coronary aneurysm and restenosis after bioresorbable vascular scaffold implantation: a case report. Eur Heart J Case Rep 2024; 8:ytae065. [PMID: 38332923 PMCID: PMC10852101 DOI: 10.1093/ehjcr/ytae065] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2023] [Revised: 01/22/2024] [Accepted: 01/26/2024] [Indexed: 02/10/2024]
Abstract
Background Although the technology of bioresorbable vascular scaffold (BVS) aroused the peak of interest a few years ago and currently remains available only as part of experimental research, patients who have had BVS implanted should be still carefully monitored to detect possible long-term complications. Case summary We present the case of a 47-year-old man who had received BVS implantation for ST-segment elevation myocardial infarction. Six years later, computed tomography coronary angiography (CTCA) demonstrated in-segment restenosis in between two newly formed coronary aneurysms at the site of the implanted BVS. The patient received successful optical coherence tomography-guided percutaneous intervention with a new metallic drug-eluting stent implantation. Discussion Our case demonstrates that coronary aneurysms can be well characterized with CTCA and are often incidentally discovered as they cause no symptoms. The incidence of coronary aneurysm at the site of a previously implanted BVS is not defined, and little is known about the pathophysiology and evolution of these lesions. Therefore, the decision to proceed with conservative management or intervention must be tailored to the clinical conditions of the patient, the anatomy, the rapidity of growth, and the possible thrombotic burden.
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Affiliation(s)
- Antonino Micari
- Department of Clinical and Experimental Medicine, University of Messina and AOU Policlinico ‘Gaetano Martino’, Via Consolare Valeria, 98122 Messina, Italy
| | - Angelo Dimartino
- Department of Clinical and Experimental Medicine, University of Messina and AOU Policlinico ‘Gaetano Martino’, Via Consolare Valeria, 98122 Messina, Italy
| | - Rocco Donato
- Department of Biomedical and Dental Sciences and Morphological and Functional Imaging, University of Messina and AOU Policlinico ‘Gaetano Martino’, Via Consolare Valeria, 98122 Messina, Italy
| | - Giampiero Vizzari
- Department of Clinical and Experimental Medicine, University of Messina and AOU Policlinico ‘Gaetano Martino’, Via Consolare Valeria, 98122 Messina, Italy
| | - Giuseppe Andò
- Department of Clinical and Experimental Medicine, University of Messina and AOU Policlinico ‘Gaetano Martino’, Via Consolare Valeria, 98122 Messina, Italy
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15
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Saito S, Bennett J, Nef HM, Webster M, Namiki A, Takahashi A, Kakuta T, Yamazaki S, Shibata Y, Scott D, Vrolix M, Menon M, Möllmann H, Werner N, Neylon A, Mehmedbegovic Z, Smits PC, Morice MC, Verheye S, BIOADAPTOR-RCT Collaborators. First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT. EClinicalMedicine 2023; 65:102304. [PMID: 38106564 PMCID: PMC10725075 DOI: 10.1016/j.eclinm.2023.102304] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2023] [Revised: 10/10/2023] [Accepted: 10/13/2023] [Indexed: 12/19/2023] Open
Abstract
Background The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function. Methods This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747). Findings 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority < 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p < 0.001). Interpretation This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function. Funding The study was funded by Elixir Medical.
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Affiliation(s)
- Shigeru Saito
- Heart Center, Iryohojin Tokushukai Shonan Kamakura General Hospital, Kamakura City, Japan
| | - Johan Bennett
- Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium
| | - Holger M. Nef
- Department of Cardiology and Angiology, University of Giessen, Giessen, Germany
| | - Mark Webster
- Cardiac Investigation Unit, Auckland City Hospital, Auckland, New Zealand
| | - Atsuo Namiki
- Department of Cardiology, Kanto Rosai Hospital, Nakahara-ku, Kawasaki-shi, Japan
| | | | - Tsunekazu Kakuta
- Cardiovascular Medicine, Tsuchiura Kyodo Hospital, Tsuchiura City, Japan
| | - Seiji Yamazaki
- Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan
| | - Yoshisato Shibata
- Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki City, Japan
| | - Douglas Scott
- Department of Cardiology, Middlemore Hospital, Auckland, New Zealand
| | - Mathias Vrolix
- Department of Cardiology, Ziekenhuis Oost-Limburg, Campus Sint Jan, Genk, Belgium
| | - Madhav Menon
- Department of Cardiology, Waikato Hospital, Hamilton, New Zealand
| | - Helge Möllmann
- Department of Cardiology, St. Johannes Hospital Dortmund, Dortmund, Germany
| | - Nikos Werner
- Department of Cardiology, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany
| | - Antoinette Neylon
- CERC (Cardiovascular European Research Center) ICPS Ramsay, Massy, France
| | | | - Pieter C. Smits
- CERC (Cardiovascular European Research Center) ICPS Ramsay, Massy, France
| | | | - Stefan Verheye
- Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium
| | - BIOADAPTOR-RCT Collaborators
- Heart Center, Iryohojin Tokushukai Shonan Kamakura General Hospital, Kamakura City, Japan
- Department of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium
- Department of Cardiology and Angiology, University of Giessen, Giessen, Germany
- Cardiac Investigation Unit, Auckland City Hospital, Auckland, New Zealand
- Department of Cardiology, Kanto Rosai Hospital, Nakahara-ku, Kawasaki-shi, Japan
- Department of Cardiology, Takahashi Hospital, Kobe City, Japan
- Cardiovascular Medicine, Tsuchiura Kyodo Hospital, Tsuchiura City, Japan
- Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan
- Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki City, Japan
- Department of Cardiology, Middlemore Hospital, Auckland, New Zealand
- Department of Cardiology, Ziekenhuis Oost-Limburg, Campus Sint Jan, Genk, Belgium
- Department of Cardiology, Waikato Hospital, Hamilton, New Zealand
- Department of Cardiology, St. Johannes Hospital Dortmund, Dortmund, Germany
- Department of Cardiology, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany
- CERC (Cardiovascular European Research Center) ICPS Ramsay, Massy, France
- Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium
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16
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Hwang JJ, Kao HL, Lin MS, Wu CK, Chiang FT, Wang YC. Impact of post-implantation time on bioresorbable vascular scaffold outcomes for type C versus non-type C coronary lesions: A longer-term study. J Formos Med Assoc 2023; 122:1018-1027. [PMID: 37349171 DOI: 10.1016/j.jfma.2023.05.039] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2023] [Revised: 05/08/2023] [Accepted: 05/31/2023] [Indexed: 06/24/2023] Open
Abstract
BACKGROUND We have demonstrated that bioresorbable vascular scaffold (BVS) for ACC/AHA type C lesions was associated with higher risks of long-term target lesion revascularization (TLR) and target lesion failure (TLF). We determined the specific time after which higher risks of BVS for type C lesions are reduced in a longer-term follow-up. METHODS We analyzed data of 457 patients (59 ± 12 years, 87% male) with 714 BVS implanted for 529 lesions and a median follow-up of 56.4 (48.6-62.6) months. Patients with BVS for at least one type C lesion (N = 177) at index intervention and all non-type C lesions (N = 280) were compared for TLF (cardiac death, target vessel myocardial infarction, TLR). We specified the interactions between the non-type C versus type C group and the event-free survival times dichotomized at 24, 30, 32, 33, 36, and 39 months respectively. RESULTS The type C group had more multivessel disease (86% versus 65%, p < 0.001), left anterior descending artery treated (68% versus 53%, p = 0.002), intravascular imaging used (48% vs. 25%, p < 0.001), and BVS (2.3 ± 0.9 vs. 1.1 ± 0.3, p < 0.001) implanted with a longer total length (57 ± 21 vs. 29 ± 8 mm, p < 0.001). The TLR or TLF was higher (both log-rank p < 0.05) in the type C than in the non-type C group. However, the risks of TLR (hazard ratio: 3.6, 95% CI = 1.1-11.6) and TLF (hazard ratio: 3.8, 95% CI = 1.2-12.1) for type C lesions only remained higher until 24 months post-BVS implantation. CONCLUSION BVS provides a longer-term advantage, particularly for type C lesions with the majority requiring long stenting.
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Affiliation(s)
- Juey-Jen Hwang
- No. 7, Chung-Shan South Road, Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital, Taipei, 100, Taiwan
| | - Hsien-Li Kao
- No. 7, Chung-Shan South Road, Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital, Taipei, 100, Taiwan
| | - Mao-Shin Lin
- No. 7, Chung-Shan South Road, Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital, Taipei, 100, Taiwan
| | - Cho-Kai Wu
- No. 7, Chung-Shan South Road, Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital, Taipei, 100, Taiwan
| | - Fu-Tien Chiang
- No. 7, Chung-Shan South Road, Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital, Taipei, 100, Taiwan; Division of Cardiology, Department of Internal Medicine, Fu Jen Catholic University and Fu-Jen Catholic University Hospital, New Taipei City, Taiwan
| | - Yi-Chih Wang
- No. 7, Chung-Shan South Road, Cardiovascular Division, Department of Internal Medicine, National Taiwan University Hospital, Taipei, 100, Taiwan.
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17
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Liu W, Huang J, He S, Du R, Shi W, Wang Y, Du D, Du Y, Liu Q, Wang Y, Wang G, Yin T. Senescent endothelial cells' response to the degradation of bioresorbable scaffold induces intimal dysfunction accelerating in-stent restenosis. Acta Biomater 2023; 166:266-277. [PMID: 37211308 DOI: 10.1016/j.actbio.2023.05.028] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2023] [Revised: 05/16/2023] [Accepted: 05/16/2023] [Indexed: 05/23/2023]
Abstract
Atherosclerotic cardiovascular disease is a typical age-related disease accompanied by stiffening arteries. We aimed to elucidate the influence of aged arteries on in-stent restenosis (ISR) after the implantation of bioresorbable scaffolds (BRS). Histology and optical coherence tomography showed increased lumen loss and ISR in the aged abdominal aorta of Sprague-Dawley rats, with apparent scaffold degradation and deformation, which induce lower wall shear stress (WSS). This was also the case at the distal end of BRS, where the scaffolds degraded faster, and significant lumen loss was followed by a lower WSS. In addition, early thrombosis, inflammation, and delayed re-endothelialization were presented in the aged arteries. Degradation of BRS causes more senescent cells in the aged vasculature, increasing endothelial cell dysfunction and the risk of ISR. Thus, profoundly understanding the mechanism between BRS and senescent cells may give a meaningful guide for the age-related scaffold design. STATEMENT OF SIGNIFICANCE: The degradation of bioresorbable scaffolds aggravates senescent endothelial cells and a much lower wall shear stress areas in the aged vasculature, lead to intimal dysfunction and increasing in-stent restenosis risk. Early thrombosis and inflammation, as well as delayed re-endothelialization, are presented in the aged vasculature after bioresorbable scaffolds implantation. Age stratification during the clinical evaluation and senolytics in the design of new bioresorbable scaffolds should be considered, especially for old patients.
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Affiliation(s)
- Wanling Liu
- Key Laboratory of Biorheological and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Modern Life Science Experiment Teaching Center, Bioengineering College of Chongqing University, Chongqing 400030, PR China
| | - Junyang Huang
- Key Laboratory of Biorheological and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Modern Life Science Experiment Teaching Center, Bioengineering College of Chongqing University, Chongqing 400030, PR China
| | - Shicheng He
- State Key Laboratory of Bioelectronics, School of Biological Science and Medical Engineering, Southeast University, Nanjing 210096, China
| | - Ruolin Du
- Key Laboratory of Biorheological and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Modern Life Science Experiment Teaching Center, Bioengineering College of Chongqing University, Chongqing 400030, PR China
| | - Wen Shi
- Key Laboratory of Biorheological and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Modern Life Science Experiment Teaching Center, Bioengineering College of Chongqing University, Chongqing 400030, PR China
| | - Yang Wang
- Key Laboratory of Biorheological and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Modern Life Science Experiment Teaching Center, Bioengineering College of Chongqing University, Chongqing 400030, PR China
| | - Dingyuan Du
- Department of Traumatology, and Department of Cardiothoracic Surgery, Chongqing University Central Hospital, Chongqing Emergency Medical Center, Chongqing 400014, China
| | - Yan Du
- Ultrasonography Department, Chongqing University Central Hospital, Chongqing Emergency Medical Center, Chongqing 400014, China
| | - Qing Liu
- Beijing Advanced Medical Technologies Inc., Beijing 102609, China
| | - Yazhou Wang
- School of Medicine, Chongqing University, Chongqing 400044, PR China.
| | - Guixue Wang
- Key Laboratory of Biorheological and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Modern Life Science Experiment Teaching Center, Bioengineering College of Chongqing University, Chongqing 400030, PR China.
| | - Tieying Yin
- Key Laboratory of Biorheological and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Modern Life Science Experiment Teaching Center, Bioengineering College of Chongqing University, Chongqing 400030, PR China.
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18
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Abubakar M, Javed I, Rasool HF, Raza S, Basavaraju D, Abdullah RM, Ahmed F, Salim SS, Faraz MA, Hassan KM, Hajjaj M. Advancements in Percutaneous Coronary Intervention Techniques: A Comprehensive Literature Review of Mixed Studies and Practice Guidelines. Cureus 2023; 15:e41311. [PMID: 37539426 PMCID: PMC10395399 DOI: 10.7759/cureus.41311] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/03/2023] [Indexed: 08/05/2023] Open
Abstract
Percutaneous coronary intervention (PCI) is a widely used therapy for coronary artery disease (CAD), but it carries risks and complications. Adhering to evidence-based practice guidelines is crucial for optimal outcomes. This review compares the recommendations of the 2021 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) and 2018 European Society of Cardiology (ESC) guidelines for coronary artery revascularization and discusses emerging trends and novel devices in PCI. A comprehensive literature review of mixed studies, clinical trials, and guidelines was conducted. Intravascular imaging, including intravascular ultrasound and optical coherence tomography, for stent optimization, is also recommended when feasible. However, differences reflecting variations in evidence quality interpretation and applicability were identified. Furthermore, novel devices and technologies with the potential for improving outcomes were highlighted, but their safety and efficacy compared to standard-of-care techniques require further evaluation through extensive randomized trials. Clinicians should stay updated on advancements and personalize treatment decisions based on individual patient factors. Future research should address evidence gaps and barriers to adopting innovative devices and techniques. This review provides recommendations for clinical practice, emphasizing the need to remain current with the evolving landscape of PCI to optimize patient outcomes. The discoveries provide valuable counsel for the deliberation of clinical interventions and prospective inquiries within the realm of interventional cardiology. Overall, the review underscores the importance of evidence-based practice and ongoing advancements in PCI for CAD management.
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Affiliation(s)
- Muhammad Abubakar
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
- Department of Internal Medicine, Siddique Sadiq Memorial Trust Hospital, Gujranwala, PAK
| | - Izzah Javed
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Hafiz Fahad Rasool
- Department of Public Health, School of Public Health, Nanjing Medical University, Nanjing, CHN
| | - Saud Raza
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Deepak Basavaraju
- Department of Internal Medicine, Mysore Medical College and Research Institute, Mysore, IND
| | | | - Faizan Ahmed
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Siffat S Salim
- Department of Surgery, Holy Family Red Crescent Medical College Hospital, Dhaka, BGD
| | - Muhammad Ahmad Faraz
- Department of Forensic Medicine, Post Graduate Medical Institute, Lahore General Hospital, Lahore, PAK
| | - Khawaja Mushammar Hassan
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Mohsin Hajjaj
- Department of Internal Medicine, Jinnah Hospital, Lahore, PAK
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El Khoury R, Tzvetanov I, Estrada EA, McCarroll E, Goor JB, Guy LG, Laflamme M, Schwartz LB. Drug-eluting, balloon-expandable, bioresorbable vascular scaffolds reduce neointimal thickness and stenosis in an animal model of percutaneous peripheral intervention. JVS Vasc Sci 2023; 4:100114. [PMID: 37546529 PMCID: PMC10403740 DOI: 10.1016/j.jvssci.2023.100114] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2023] [Accepted: 05/31/2023] [Indexed: 08/08/2023] Open
Abstract
Objective Recanalization with balloon angioplasty and/or self-expanding stents (SES) has become the endovascular treatment of choice for symptomatic femoropopliteal occlusive disease. These strategies generate suboptimal clinical results, however, because they fail to expand the artery fully and ineffectively prevent recoil, neointimal hyperplasia, and restenosis. Balloon-expandable stents, given their greater radial force and rigid structure, represent a more effective treatment strategy, but only short lengths can be implanted safely in arteries that deform and bend with skeletal motion. The purpose of this preclinical experiment was to test the hypothesis that simultaneous implantation of a series of short, resorbable, balloon-expandable, paclitaxel-eluting scaffolds would prevent neointimal hyperplasia and stenosis compared with SES in an animal model of percutaneous femoropopliteal intervention. Methods We extruded 6 × 60 mm Efemoral Vascular Scaffold Systems (EVSS) from copolymers of poly-L-lactic acid, coated with paclitaxel 3 μg/mm2, crimped onto a single delivery balloon, and implanted percutaneously into the iliofemoral arteries of eight Yucatan mini-swine. We implanted 7- to 8-mm × 60 mm SES into the contralateral experimental arteries. The animals were serially imaged with contrast angiography and optical coherence tomography after 30, 90, 180, 365, and 730 days. The primary end point of this study was neointimal morphometry over time. Secondary end points included acute deformation and angiographic and optical coherence tomography-derived measurements of chronic vascular response. Results Over the 2-year study period, one SES was found to be completely occluded at 90 days; all EVSS were widely patent at all time points. Arteries treated with SES exhibited profound neointimal hyperplasia with in-stent stenosis. In contrast, arteries treated with EVSS exhibited only modest vascular responses and minimal stenosis. After 2 years, the mean neointimal thickness (0.45 ± 0.12 vs 1.31 ± 0.91 mm; P < .05) and area (8.41 ± 3.35 vs 21.86 ± 7.37 mm2; P < .05) were significantly decreased after EVSS implantation. By 2 years, all scaffolds in all EVSS-treated arteries had resorbed fully. Conclusions In this preclinical animal model of peripheral endovascular intervention, the EVSS decreased neointimal hyperplasia and stenosis significantly compared with SES, then dissolved completely between the first and second years after implantation.
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Affiliation(s)
| | | | | | | | | | | | | | - Lewis B. Schwartz
- Efemoral Medical, Inc., Los Altos, CA
- Department of Surgery, Advocate Lutheran General Hospital, Park Ridge, IL
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20
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Li C, Chen H, Wang M, Zhang S, Jiang Y, Xian Z, Shen C, Guo J, Song C, Gong H, Ye N, Zhao X. Preliminary studies on intimal injury related to stent retrieval in a canine model. Biochem Biophys Res Commun 2023; 670:102-108. [PMID: 37290284 DOI: 10.1016/j.bbrc.2023.05.122] [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: 04/24/2023] [Revised: 05/09/2023] [Accepted: 05/30/2023] [Indexed: 06/10/2023]
Abstract
OBJECTIVE This pilot study aimed to observe intimal injuries related to stent retrieval in the iliac artery of a canine. BACKGROUND In-stent restenosis remains challenging owing to permanent stent implantation. A retrievable stent may be alternative for intervention without permanent residue. METHODS Five retrievable stents with point-to-point overlapped double-layer scaffolds were deployed into the iliac arteries and retrieved on days 14, 21, 28, 35, and 42 from five canines. RESULTS Arterial diameter decreased by 9-10% before retrieval and 15% on day 14 after retrieval. In the 14-day-stent, the stent surface was clean without visible fibrin. In the 28-day-stent, the overlay was mainly composed of fibrin and fibroblasts. The proliferation of smooth muscle cells has not yet been observed with α-smooth muscle actin staining. In the 42-day-stent, endothelial and smooth muscle cells decreased under the struts, and the internal elastic lamina was interrupted segmentally. Neointima formation involves fibroblasts and smooth muscle cells. Neointimal thickness was negatively correlated with strut space. Stent traces on the artery wall tended to be flat at a follow-up14 days after retrieval. The primary intima was completely covered by neointima. Two stents could not be retrieved because of in-stent thrombosis or capture loss. CONCLUSIONS The stent was covered mainly by depositional fibrin after 28 days and by typical neointima after 42 days. The stent retrieval procedure did not induce injury to vascular smooth muscle, and the intima repair was performed 14 days after stent retrieval.
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Affiliation(s)
- Cong Li
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Houliang Chen
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Minghong Wang
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Shujie Zhang
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Yujuan Jiang
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Zhihong Xian
- Pathology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China
| | - Cuiqin Shen
- Ultrasonography, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China
| | - Jingzhen Guo
- Shanghai Institute for Minimally Invasive Therapy, School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai, 200093, China
| | - Chengli Song
- Shanghai Institute for Minimally Invasive Therapy, School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai, 200093, China
| | - Hui Gong
- Cardiology, Jin Shan Hospital, Fudan University, Shanghai, 201500, China
| | - Nan Ye
- Cardiology, Jin Shan Hospital, Fudan University, Shanghai, 201500, China
| | - Xue Zhao
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University.
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21
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Lee JM, Joh HS, Choi KH, Hong D, Park TK, Yang JH, Song YB, Choi JH, Choi SH, Jeong JO, Lee JY, Choi YJ, Chae JK, Hur SH, Bae JW, Oh JH, Chun KJ, Kim HJ, Cho BR, Shin D, Lee SH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Shin ES, Doh JH, Hahn JY, Gwon HC. Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice. J Korean Med Sci 2023; 38:e34. [PMID: 36747363 PMCID: PMC9902667 DOI: 10.3346/jkms.2023.38.e34] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2022] [Accepted: 10/27/2022] [Indexed: 01/15/2023] Open
Abstract
BACKGROUND The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. METHODS The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. RESULTS Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. CONCLUSION With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.
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Affiliation(s)
- Joo Myung Lee
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Hyun Sung Joh
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Ki Hong Choi
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - David Hong
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Taek Kyu Park
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jeong Hoon Yang
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Young Bin Song
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jin-Ho Choi
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Seung-Hyuk Choi
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jin-Ok Jeong
- Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea
| | - Jong-Young Lee
- Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Young Jin Choi
- Division of Cardiology, Department of Internal Medicine, Bucheon Sejong Hospital, Bucheon, Korea
| | - Jei-Keon Chae
- Division of Cardiology, Department of Internal Medicine, Jeonbuk National University Hospital and Jeonbuk National University Medical School, Jeonju, Korea
| | - Seung-Ho Hur
- Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea
| | - Jang-Whan Bae
- Division of Cardiology, Department of Internal Medicine, Chungbuk National University, Cheongju, Korea
| | - Ju-Hyeon Oh
- Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
| | - Kook-Jin Chun
- Department of Cardiology, Pusan National University Yangsan Hospital, Yangsan, Korea
| | - Hyun-Joong Kim
- Division of Cardiology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea
| | - Byung Ryul Cho
- Division of Cardiology, Department of Internal Medicine, Kangwon National University Hospital, Kangwon National University College of Medicine, Chuncheon, Korea
| | - Doosup Shin
- Division of Cardiovascular Medicine, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, IA, USA
| | - Seung Hun Lee
- Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea
| | - Doyeon Hwang
- Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea
| | - Hyun-Jong Lee
- Division of Cardiology, Department of Internal Medicine, Bucheon Sejong Hospital, Bucheon, Korea
| | - Ho-Jun Jang
- Division of Cardiology, Department of Internal Medicine, Bucheon Sejong Hospital, Bucheon, Korea
| | - Hyun Kuk Kim
- Department of Internal Medicine and Cardiovascular Center, Chosun University Hospital, University of Chosun College of Medicine, Gwangju, Korea
| | - Sang Jin Ha
- Division of Cardiology, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea
| | - Eun-Seok Shin
- Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
| | - Joon-Hyung Doh
- Department of Cardiology, Inje University Ilsan Paik Hospital, Goyang, Korea
| | - Joo-Yong Hahn
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
| | - Hyeon-Cheol Gwon
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
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Contorni F, Cameli M, Iadanza A, Carrera A, Guerrieri G, Barbati R, Sinicropi G, Bacci E, Baccani B, Fineschi M. Four-year outcomes of a single-center experience with coronary everolimus-eluting bioresorbable scaffolds. Minerva Cardiol Angiol 2023; 71:70-76. [PMID: 34338484 DOI: 10.23736/s2724-5683.21.05703-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
BACKGROUND Bioresorbable scaffolds (BRS) have been introduced to overcome the limitations of drug-eluting stents and the ABSORB (Everolimus-Eluting BRS, Abbott Vascular, Santa Clara, CA, USA) was the most extensively tested. Nevertheless, major RCTs reported higher rates of target lesion failures and BRS thrombosis at 3 years follow-up, bringing to the withdrawing of the device from the market. It has been suggested that a better lesions selection and an optimized implantation technique could mitigate the displayed adverse results. METHODS Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 4 years. Endpoint of interest was the target lesion failure (TLF), a composite outcome including cardiac death, target vessel myocardial infarction and target lesion revascularization. RESULTS A total of 62 patients with a mean age of 55±8.5 years were analyzed of which 70.9% presented with an acute coronary syndrome and 59.6% with myocardial infarction. A total of 100 lesions were treated and 51.6% were complex (B2/C). Predilatation was performed in all the case, post-dilatation in 74.1%. All the target vessel reference diameter (RVD) were >2.5 mm (average RVD 3.2±0.24 mm). At 4 years, the rate for TLF was 6.9%. Subgroup's analysis did not show significative differences among groups although consistently higher event rates were found for RVD <2.5 mm (12.6% vs. 6.4%, P=0.5), BRS overlapping (11.8% vs. 5%, P=0.2) and ticagrelor instead of clopidogrel on top of cardioaspirin (9.1% vs. 3%, P=0.2). CONCLUSIONS This small-sized real-world registry displays lower rates of clinical events during long-term follow-up in respect to previous studies. The avoidance of implantation in small vessels, inclusion of acute myocardial infarction and extensive performance of BRS post-dilatation could explain the observed better results. Long-term outcomes of the ongoing ABSORB IV Trial are needed to confirm this data.
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Affiliation(s)
- Francesco Contorni
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy -
| | - Matteo Cameli
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Alessandro Iadanza
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Arcangelo Carrera
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Giuseppe Guerrieri
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Riccardo Barbati
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Giuseppe Sinicropi
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Elodi Bacci
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Bernardo Baccani
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
| | - Massimo Fineschi
- Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy
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23
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Cheng JF, Lee CL, Chiang JY, Wu CK, Wang YC, Tsai CT, Liu SC, Tsai CT, Chang CJ, Hwang JJ. Impact of Selection Preference on Longer-Term Outcomes between Bioresorbable Vascular Scaffold versus Everolimus-Eluting Stent for True Lumen Tracking-Recanalized Chronic Total Occlusion. Int Heart J 2023; 64:154-163. [PMID: 37005311 DOI: 10.1536/ihj.22-581] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/04/2023]
Abstract
Creation of sizable subintima during intervention for chronic total occlusions (CTO) could lead to the key selection preference of metallic stents rather than bioresorbable vascular scaffolds (BVS) and then possibly deviate the outcome comparisons in real-world studies. By including recanalized CTO with true lumen tracking, we tested if any selection preference remained and compared the outcomes between everolimus-eluting stent (EES) and BVS implantation.Among 211 consecutive CTO interventions with true lumen tracking from August 2014 to April 2018 when BVS was available, we compared the clinical and interventional features between 28 patients with BVS and 77 patients with EES implantation. With propensity score matching and a median follow-up of 50.5 (37.3-60.3) months, we further assessed 25 patients with BVS and 25 with EES for target vessel failure (TVF: cardiac death, target vessel myocardial infarction, and target lesion revascularization).Multivariate analyses showed that BVS was still favored in the presence of LAD CTO (odds ratio (OR) = 3.4, 95% confidence interval (CI) = 1.0-11.7) and an average scaffold/stent size ≥ 3 mm (OR = 10.5, 95% CI = 3.0-37.3). EES was preferred for lesions with a J-CTO score ≥ 3 (OR = 19.3, 95% CI = 3.4-110.8) and multivessel intervention necessary at index procedure (OR = 11.3, 95% CI = 1.9-67.3). With matched comparisons, the TVF-free survival of EES was better than that of BVS for CTO recanalization (P = 0.049 by log-rank test) at long-term follow-up.Even with true lumen tracking techniques, selection bias remained substantial when determining either device for CTO implantation. The matched comparison of outcomes suggested the unfavorable longer-term impacts of the first generation of BVS on CTO lesions.
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Affiliation(s)
- Jen-Fang Cheng
- Division of Cardiovascular, Department of Internal Medicine, National Taiwan University Hospital
| | - Chien-Lin Lee
- Division of Cardiovascular, Department of Internal Medicine, Far Eastern Memorial Hospital
| | - Jiun-Yang Chiang
- Division of Cardiovascular, Department of Internal Medicine, National Taiwan University Hospital
| | - Cho-Kai Wu
- Division of Cardiovascular, Department of Internal Medicine, National Taiwan University Hospital
| | - Yi-Chih Wang
- Division of Cardiovascular, Department of Internal Medicine, National Taiwan University Hospital
| | - Chia-Ti Tsai
- Division of Cardiovascular, Department of Internal Medicine, National Taiwan University Hospital
| | - Shih-Chi Liu
- Division of Cardiovascular, Department of Internal Medicine, Fu Jen Catholic University Hospital
| | - Cheng-Ting Tsai
- Division of Cardiovascular, Department of Internal Medicine, MacKay Memorial Hospital
| | - Chi-Jen Chang
- Division of Cardiovascular, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou
| | - Juey-Jen Hwang
- Division of Cardiovascular, Department of Internal Medicine, National Taiwan University Hospital
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24
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Doenst T, Thiele H, Haasenritter J, Wahlers T, Massberg S, Haverich A. The Treatment of Coronary Artery Disease. DEUTSCHES ARZTEBLATT INTERNATIONAL 2022; 119:716-723. [PMID: 35912444 PMCID: PMC9835700 DOI: 10.3238/arztebl.m2022.0277] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/06/2022] [Revised: 04/06/2022] [Accepted: 07/06/2022] [Indexed: 11/05/2022]
Abstract
BACKGROUND The first coronary artery bypass operation (CABG) was performed on May 2, 1960. The first percutaneous coro - nary intervention (PCI) was performed almost 20 years later. Since then, the invasive treatment of coronary artery disease (CAD) has moved into the spotlight of cardiac medical care. METHODS We summarize the current status of medical and invasive CAD treatment through a selective review of the literature. RESULTS More than 800 000 patients currently undergo invasive diagnostic and therapeutic procedures for CAD in Germany each year. The number of coronary artery bypass grafting (CABG) procedures rose to 65 000/year by the turn of the millennium and has been declining since then. In contrast, the number of PCIs in Germany rose to approximately 350 000/year by 2017, and a beginning decline is being observed at present. This development occurred even though, for elective patients, a survival advantage from an invasive procedure compared to medical therapy has been shown in direct comparison only for CABG. CONCLUSION Conservative treatment is always the baseline treatment and has undergone major advances in the last few decades. Moreover, non-invasive coronary evaluation with computed tomography, as well as non-invasive cardiac stress imaging studies, are increasingly replacing primary invasive coronary evaluations. In this review, we illustrate a mechanistic concept of the appropriate use of CABG and PCI that can improve patient care, while underscoring the importance of interdisciplinary and intersectoral collaboration.
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Affiliation(s)
- Torsten Doenst
- Department of Cardiothoracic Surgery at Jena University Hospital, Friedrich-Schiller University of Jena
| | - Holger Thiele
- University Department of Cardiology, Leipzig Heart Center
| | - Jörg Haasenritter
- Department of General Practice, Preventive and Rehabilitation Medicine, Philipps University of Marburg
| | - Thorsten Wahlers
- Department of Heart Surgery, Intensive Care Medicine and Thoracic Surgery at University Hospital of Cologne
| | - Steffen Massberg
- Medical Clinic and Polyclinic I, University Hospital of Ludwig Maximilian University of Munich
- German Center for Cardiovascular Research (DZHK)
| | - Axel Haverich
- Department of Cardiothoracic, Transplantation and Vascular Surgery, Hanover Medical School
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25
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Jackson-Smith E, Zioupos S, Banerjee P. Bioresorbable vascular scaffolds versus conventional drug-eluting stents across time: a meta-analysis of randomised controlled trials. Open Heart 2022; 9:e002107. [PMID: 36288820 PMCID: PMC9615997 DOI: 10.1136/openhrt-2022-002107] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/30/2022] [Accepted: 09/12/2022] [Indexed: 11/07/2022] Open
Abstract
BACKGROUND Bioresorbable vascular scaffolds (BVS) were designed to reduce the rate of late adverse events observed in conventional drug-eluting stents (DES) by dissolving once they have restored lasting patency. OBJECTIVES Compare the safety and efficacy of BVS versus DES in patients receiving percutaneous coronary intervention for coronary artery disease across a complete range of randomised controlled trial (RCT) follow-up intervals. METHODS A systematic review and meta-analysis was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. MEDLINE, EMBASE and Web of Science were searched from inception through 5 January 2022 for RCTs comparing the clinical outcomes of BVS versus DES. The primary safety outcome was stent/scaffold thrombosis (ST), and the primary efficacy outcome was target lesion failure (TLF: composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR)). Secondary outcomes were patient-oriented composite endpoint (combining all-death, all-MI and all-revascularisation), its individual components and those of TLF. Studies were appraised using Cochrane's Risk of Bias tool and meta-analysis was performed using RevMan V.5.4. RESULTS 11 919 patients were randomised to receive either BVS (n=6438) or DES (n=5481) across 17 trials (differing follow-up intervals from 3 months to 5 years). BVS demonstrated increased risk of ST across all timepoints (peaking at 2 years with risk ratio (RR): 3.47; 95% CI 1.80 to 6.70; p=0.0002). Similarly, they showed increased risk of TLF (peaking at 3 years, RR: 1.35; 95% CI 1.07 to 1.70; p=0.01) resulting from high rates of TVMI and ID-TLR. Though improvements were observed after device dissolution (5-year follow-up), these were non-significant. All other outcomes were statistically equivalent. Applicability to all BVS is limited by 91% of the BVS group receiving Abbott's Absorb. CONCLUSION This meta-analysis demonstrates that current BVS are inferior to contemporary DES throughout the first 5 years at minimum.
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Affiliation(s)
| | | | - Prithwish Banerjee
- Warwick Medical School, University of Warwick, Coventry, UK
- Centre for Sports, Exercise & Life Sciences (CSELS), Coventry University Faculty of Health and Life Sciences, Coventry, UK
- Department of Cardiology, University Hospitals Coventry and Warwickshire, Coventry, UK
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Landolff Q, Lefèvre T, Fajadet J, Sainsous J, Lhermusier T, Elhadad S, Tarragano F, Ranc S, Ghostine S, Cayla G, Marco F, Garot P, Maillard L, Motreff P, Delarche N, De Labriolle A, Pansieri M, Morelle JF, Cazaux P, Moulichon ME, Chopat P, Angoulvant D, Bataille V, Le Breton H, Koning R. Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry. Arch Cardiovasc Dis 2022; 115:505-513. [PMID: 36123284 DOI: 10.1016/j.acvd.2022.05.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2022] [Revised: 05/19/2022] [Accepted: 05/23/2022] [Indexed: 11/24/2022]
Abstract
BACKGROUND Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. AIM The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. METHODS All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. RESULTS Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. CONCLUSIONS Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.
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Affiliation(s)
| | - Thierry Lefèvre
- Institut cardiovasculaire Paris Sud, Ramsay-Générale de Santé, hôpital privé Jacques-Cartier, 91300 Massy, France
| | | | | | | | - Simon Elhadad
- Centre hospitalier de Marne-la-Vallée, 77600 Jossigny, France
| | | | - Sylvain Ranc
- Centre hospitalier Saint-Joseph Saint-Luc, 69007 Lyon, France
| | - Saïd Ghostine
- Hôpital Marie-Lannelongue (groupe hospitalier Paris Saint-Joseph), 92350 Le Plessis-Robinson, France
| | | | | | - Philippe Garot
- Hôpital privé Claude-Galien, 91480 Quincy-sous-Sénart, France
| | | | | | | | | | | | | | - Pierre Cazaux
- Centre hospitalier de Bretagne Sud Site de Scorff, 56322 Lorient, France
| | | | - Patrick Chopat
- Centre hospitalier territorial, hôpital Gaston-Bourret, 98800 Nouméa, Nouvelle-Calédonie, France
| | | | - Vincent Bataille
- ADIMEP, université Paul-Sabatier, Toulouse III, 31400 Toulouse, France
| | | | - René Koning
- Clinique Saint-Hilaire, 76000 Rouen, France.
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Liu Y, Zheng B, Zhang B, Ndondo-lay R, Nie F, Tang N, Miao Y, Li J, Huo Y. Five-year comparative study of thin-strut rapamycin-eluting bioabsorbable scaffold with metallic drug-eluting stent in porcine coronary artery. Front Cardiovasc Med 2022; 9:938519. [PMID: 35935636 PMCID: PMC9355424 DOI: 10.3389/fcvm.2022.938519] [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: 05/07/2022] [Accepted: 06/30/2022] [Indexed: 11/21/2022] Open
Abstract
Objectives Using quantitative coronary angiography (QCA), optical coherence tomography (OCT), histomorphometry, and pharmacokinetics, this study tried to evaluate the safety and efficacy of Biomagic rapamycin-eluting bioabsorbable scaffold (BVS) in non-atherosclerotic porcine coronary arteries. Background Biomagic BVS is a new generation of thin-strut bioabsorbable scaffold. We conducted comparative study detailing pathological response, safety and efficacy of Biomagic BVS and the Firebird2 rapamycin-eluting cobalt-based alloy stent (DES) in a porcine coronary artery model. The animals were followed up at 14 days, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after stent implantation. Methods A total of 143 devices (95 Biomagic and 48 Firebird2) were implanted in 2 or 3 main coronary arteries of 76 nonatherosclerotic swine and examined by QCA, OCT, light microscopy, and pharmacokinetics analyses at various time points. Results Vascular responses to Biomagic and Firebird2 were largely comparable at all time points, with struts being sequestered within the neointima. The degree of inflammation of both devices was mild to moderate, although the Biomagic score was higher at 14 days to 24 months. However, there was no statistical difference between the two groups except 14 days. At each follow-up time point, the percentage of area stenosis in the Biomagic group was greater than that in the Firebird 2 group, but there was no statistical difference between the two groups at 3 and 12 months. The extent of fibrin deposition was similar between Biomagic and Firebird2, which peaked at 1 month and decreased rapidly thereafter. Pharmacokinetic study showed that coronary tissue sirolimus concentration remained above 2 ng/mg of tissue at 28 day. Histomorphometry showed expansile remodeling of Biomagic-implanted arteries starting after 12 months, and lumen area was significantly greater in Biomagic than Firebird2 at 36 and 42 months. These changes correlated with dismantling of Biomagic seen after 12 months. OCT images confirmed that degradation of Biomagic was complete by 36 months. Conclusions Biomagic demonstrates comparable long-term safety to Firebird2 in porcine coronary arteries with mild to moderate inflammation. Although Biomagic was associated with greater percent stenosis relative to Firebird2 within 36 months, expansile remodeling was observed after 12 months in Biomagic with significantly greater lumen area at ≥36 months. Scaffold resorption is considered complete at 36 months.
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Affiliation(s)
- Yaokun Liu
- Department of Cardiology, Peking University First Hospital, Beijing, China
| | - Bo Zheng
- Department of Cardiology, Peking University First Hospital, Beijing, China
- Institute of Cardiovascular Disease, Peking University First Hospital, Beijing, China
| | - Bin Zhang
- Department of Cardiology, Peking University First Hospital, Beijing, China
- Institute of Cardiovascular Disease, Peking University First Hospital, Beijing, China
| | | | - Fangfang Nie
- Shanghai Biomagic Medical Devices Company Limited, Shanghai, China
| | - Naijie Tang
- Shanghai Biomagic Medical Devices Company Limited, Shanghai, China
| | - Yongsheng Miao
- Shanghai Biomagic Medical Devices Company Limited, Shanghai, China
| | - Jianping Li
- Department of Cardiology, Peking University First Hospital, Beijing, China
- Institute of Cardiovascular Disease, Peking University First Hospital, Beijing, China
- *Correspondence: Jianping Li
| | - Yong Huo
- Department of Cardiology, Peking University First Hospital, Beijing, China
- Institute of Cardiovascular Disease, Peking University First Hospital, Beijing, China
- Yong Huo
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Gupta A, Shrivastava A, Vijayvergiya R, Chhikara S, Datta R, Aziz A, Singh Meena D, Nath RK, Kumar JR. Optical Coherence Tomography: An Eye Into the Coronary Artery. Front Cardiovasc Med 2022; 9:854554. [PMID: 35647059 PMCID: PMC9130606 DOI: 10.3389/fcvm.2022.854554] [Citation(s) in RCA: 18] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2022] [Accepted: 03/24/2022] [Indexed: 01/20/2023] Open
Abstract
Optical coherence tomography (OCT) is slowly but surely gaining a foothold in the hands of interventional cardiologists. Intraluminal and transmural contents of the coronary arteries are no longer elusive to the cardiologist's probing eye. Although the graduation of an interventionalist in imaging techniques right from naked eye angiographies to ultrasound-based coronary sonographies to the modern light-based OCT has been slow, with the increasing regularity of complex coronary cases in practice, such a transition is inevitable. Although intravascular ultrasound (IVUS) due to its robust clinical data has been the preferred imaging modality in recent years, OCT provides a distinct upgrade over it in many imaging and procedural aspects. Better image resolution, accurate estimation of the calcified lesion, and better evaluation of acute and chronic stent failure are the distinct advantages of OCT over IVUS. Despite the obvious imaging advantages of OCT, its clinical impact remains subdued. However, upcoming newer trials and data have been encouraging for expanding the use of OCT to wider indications in clinical utility. During percutaneous coronary intervention (PCI), OCT provides the detailed information (dissection, tissue prolapse, thrombi, and incomplete stent apposition) required for optimal stent deployment, which is the key to successfully reducing the major adverse cardiovascular event (MACE) and stent-related morbidities. The increasing use of OCT in complex bifurcation stenting involving the left main (LM) is being studied. Also, the traditional pitfalls of OCT, such as additional contrast load for image acquisition and stenting involving the ostial and proximal LM, have also been overcome recently. In this review, we discuss the interpretation of OCT images and its clinical impact on the outcome of procedures along with current barriers to its use and newer paradigms in which OCT is starting to become a promising tool for the interventionalist and what can be expected for the immediate future in the imaging world.
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Affiliation(s)
- Ankush Gupta
- Department of Cardiology, Military Hospital Jaipur, Jaipur, India
| | - Abhinav Shrivastava
- Department of Cardiology, Dr Ram Manohar Lohia (RML) Hospital & Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS), New Delhi, India
| | - Rajesh Vijayvergiya
- Advanced Cardiac Centre, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
| | - Sanya Chhikara
- University of Minnesota Medical Center, Minneapolis, MN, United States
| | - Rajat Datta
- Director General Armed Forces Medical Services, O/o DGAFMS, Ministry of Defence, New Delhi, India
| | - Atiya Aziz
- Department of Cardiology, Military Hospital Jaipur, Jaipur, India
| | - Daulat Singh Meena
- Department of Cardiology, Jawahar Lal Nehru (J.L.N.) Medical College, Ajmer, India
| | - Ranjit Kumar Nath
- Department of Cardiology, Dr Ram Manohar Lohia (RML) Hospital & Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS), New Delhi, India
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Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, van der Schaaf RJ, Arkenbout EK, Weevers APJD, Garcia-Garcia HM, Kraak R, Piek JJ, Tijssen JGP, Henriques JPS, de Winter RJ, Wykrzykowska JJ. Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial. EUROINTERVENTION 2022; 17:1340-1347. [PMID: 34483094 PMCID: PMC9743247 DOI: 10.4244/eij-d-21-00419] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2021] [Accepted: 08/16/2021] [Indexed: 11/23/2022]
Abstract
BACKGROUND Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce. AIMS This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group. METHODS AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT. RESULTS Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86). CONCLUSIONS The excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards. Clinical Trial Registration ClinicalTrials.gov: NCT01858077.
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Affiliation(s)
- Laura S M Kerkmeijer
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | - Mick P L Renkens
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | - Ruben Y G Tijssen
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | - Sjoerd H Hofma
- Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, the Netherlands
| | | | - E Karin Arkenbout
- Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands
| | - Auke P J D Weevers
- Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands
| | | | - Robin Kraak
- Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
| | - Jan J Piek
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | - Jan G P Tijssen
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | - Jose P S Henriques
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | - Robbert J de Winter
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
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Fallesen CO, Antonsen L, Maehara A, Noori M, Hougaard M, Hansen KN, Ellert J, Ahlehoff O, Veien KT, Lassen JF, Junker AB, Hansen HS, Jensen LO. Optical coherence tomography versus angiography guided magnesium bioresorbable scaffold implantation in NSTEMI patients. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2021; 40:101-110. [PMID: 34949544 DOI: 10.1016/j.carrev.2021.12.003] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2021] [Revised: 11/30/2021] [Accepted: 12/06/2021] [Indexed: 11/26/2022]
Abstract
BACKGROUND The purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared. METHODS 75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months. RESULTS At 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5-4.7] versus 4.5 [IQR: 4.3-4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5-85.5] versus 76.5% [IQR: 67.9-85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (-27.1 ± 32.5 mm3 versus -5.0 ± 32.9 mm3; p < 0.01) and MLA (-2.3 ± 1.6 mm2 vs. -1.4 ± 1.4 mm2; p = 0.02). CONCLUSIONS In NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone. CLINICAL TRIAL REGISTRATION The Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624.
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Affiliation(s)
| | - Lisbeth Antonsen
- Department of Cardiology, Odense University Hospital, Odense, Denmark
| | - Akiko Maehara
- Cardiovascular Research Foundation, NY Presbyterian Hospital, New York, USA
| | - Manijeh Noori
- Department of Cardiology, Odense University Hospital, Odense, Denmark
| | - Mikkel Hougaard
- Department of Cardiology, Odense University Hospital, Odense, Denmark
| | | | - Julia Ellert
- Department of Cardiology, Odense University Hospital, Odense, Denmark
| | - Ole Ahlehoff
- Department of Cardiology, Odense University Hospital, Odense, Denmark
| | | | | | - Anders Bo Junker
- Department of Cardiology, Odense University Hospital, Odense, Denmark
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Yin T, Du R, Wang Y, Huang J, Ge S, Huang Y, Tan Y, Liu Q, Chen Z, Feng H, Du J, Wang Y, Wang G. Two-stage degradation and novel functional endothelium characteristics of a 3-D printed bioresorbable scaffold. Bioact Mater 2021; 10:378-396. [PMID: 34901554 PMCID: PMC8636822 DOI: 10.1016/j.bioactmat.2021.08.020] [Citation(s) in RCA: 20] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2021] [Revised: 08/17/2021] [Accepted: 08/18/2021] [Indexed: 12/13/2022] Open
Abstract
Bioresorbable scaffolds have emerged as a new generation of vascular implants for the treatment of atherosclerosis, and designed to provide a temporary scaffold that is subsequently absorbed by blood vessels over time. Presently, there is insufficient data on the biological and mechanical responses of blood vessels accompanied by bioresorbable scaffolds (BRS) degradation. Therefore, it is necessary to investigate the inflexion point of degradation, the response of blood vessels, and the pathophysiological process of vascular, as results of such studies will be of great value for the design of next generation of BRS. In this study, abdominal aortas of SD rats were received 3-D printed poly-l-actide vascular scaffolds (PLS) for various durations up to 12 months. The response of PLS implanted aorta went through two distinct processes: (1) the neointima with desirable barrier function was obtained in 1 month, accompanied with slow degradation, inflammation, and intimal hyperplasia; (2) significant degradation occurred from 6 months, accompanied with decreasing inflammation and intimal hyperplasia, while the extracellular matrix recovered to normal vessels which indicate the positive remodeling. These in vivo results indicate that 6 months is a key turning point. This “two-stage degradation and vascular characteristics” is proposed to elucidate the long-term effects of PLS on vascular repair and demonstrated the potential of PLS in promoting endothelium function and positive remodeling, which highlights the benefits of PLS and shed some light in the future researches, such as drug combination coatings design.
Proposed two-stage degradation of a PLLA BRS to reveal distinct neointimal recovery and vascular responsive processes. Revealed novel benefits of BRS, including fine endothelium function, anti-thrombosis, and anti-inflammatory. Drug combination coatings should be designed concerning special degradation of BRS and the key turning point, 6 months.
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Affiliation(s)
- Tieying Yin
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China
| | - Ruolin Du
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China
| | - Yang Wang
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China
| | - Junyang Huang
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China
| | - Shuang Ge
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China
| | - Yuhua Huang
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China
| | - Youhua Tan
- Department of Biomedical Engineering, The Hong Kong Polytechnic University, Hong Kong SAR, China
| | - Qing Liu
- Beijing Advanced Medical Technologies Inc., Beijing, 102609, China
| | - Zhong Chen
- Beijing Anzhen Hospital of Capital Medical University, Beijing, 100029, China
| | - Hanqing Feng
- Beijing Advanced Medical Technologies Inc., Beijing, 102609, China
| | - Jie Du
- Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing Anzhen Hospital, Capital Medical University, 2 Anzhen Ave, Beijing, 10029, China
| | - Yazhou Wang
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China.,School of Medicine, Chongqing University, Chongqing, 400044, China
| | - Guixue Wang
- Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030, China
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Toong DWY, Ng JCK, Cui F, Leo HL, Zhong L, Lian SS, Venkatraman S, Tan LP, Huang YY, Ang HY. Nanoparticles-reinforced poly-l-lactic acid composite materials as bioresorbable scaffold candidates for coronary stents: Insights from mechanical and finite element analysis. J Mech Behav Biomed Mater 2021; 125:104977. [PMID: 34814078 DOI: 10.1016/j.jmbbm.2021.104977] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2021] [Revised: 10/29/2021] [Accepted: 11/12/2021] [Indexed: 12/22/2022]
Abstract
Current generation of bioresorbable coronary scaffolds (BRS) posed thrombogenicity and deployment issues owing to its thick struts and overall profile. To this end, we hypothesize that the use of nanocomposite materials is able to provide improved material properties and sufficient radial strength for the intended application even at reduced strut thickness. The nanocomposite formulations of tantalum dioxide (Ta2O5), L-lactide functionalized (LA)-Ta2O5, hydroxyapatite (HA) and LA-HA with poly-l-lactic acid (PLLA) were evaluated in this study. Results showed that tensile modulus and strength were enhanced with non-functionalized nanofillers up until 15 wt% loading, whereas ductility was compromised. On the other hand, functionalized nanofillers/PLLA exhibited improved nanofiller dispersion which resulted higher tensile modulus, strength, and ductility. Selected nanocomposite formulations were evaluated using finite element analysis (FEA) of a stent with varying strut thickness (80, 100 and 150 μm). FEA data has shown that nanocomposite BRS with thinner struts (80-100 μm) made with 15 wt% LA-Ta2O5/PLLA and 10 wt% LA-HA/PLLA have increased radial strength, stiffness and reduced recoil compared to PLLA BRS at 150 μm. The reduced strut thickness can potentially mitigate issues such as scaffold thrombosis and promote re-endothelialisation of the vessel.
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Affiliation(s)
- Daniel Wee Yee Toong
- School of Materials Science and Engineering, Nanyang Technological University, Nanyang Avenue, 639798, Singapore
| | - Jaryl Chen Koon Ng
- National Heart Research Institute Singapore, National Heart Centre Singapore, 5 Hospital Drive, 169609, Singapore; Department of Biomedical Engineering, National University of Singapore, 4 Engineering Drive 3, 117583, Singapore
| | - Fangsen Cui
- Institute of High Performance Computing, A*STAR, 1 Fusionopolis way, 138632, Singapore
| | - Hwa Liang Leo
- Department of Biomedical Engineering, National University of Singapore, 4 Engineering Drive 3, 117583, Singapore
| | - Liang Zhong
- National Heart Research Institute Singapore, National Heart Centre Singapore, 5 Hospital Drive, 169609, Singapore; Duke-NUS Medical School, 8 College Road, 169857, Singapore
| | - Shaoliang Shawn Lian
- Department of Biomedical Engineering, National University of Singapore, 4 Engineering Drive 3, 117583, Singapore
| | - Subbu Venkatraman
- Department of Material Science Engineering, National University of Singapore, 9 Engineering Drive 1, 117575, Singapore
| | - Lay Poh Tan
- School of Materials Science and Engineering, Nanyang Technological University, Nanyang Avenue, 639798, Singapore
| | - Ying Ying Huang
- School of Materials Science and Engineering, Nanyang Technological University, Nanyang Avenue, 639798, Singapore.
| | - Hui Ying Ang
- National Heart Research Institute Singapore, National Heart Centre Singapore, 5 Hospital Drive, 169609, Singapore; Department of Biomedical Engineering, National University of Singapore, 4 Engineering Drive 3, 117583, Singapore; Duke-NUS Medical School, 8 College Road, 169857, Singapore.
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Arroyo D, Cook S. Absorb BRS for in-stent restenosis: the final bow before (scaffold) collapse? Open Heart 2021; 8:openhrt-2021-001838. [PMID: 34649998 PMCID: PMC8522659 DOI: 10.1136/openhrt-2021-001838] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/23/2021] [Indexed: 12/03/2022] Open
Affiliation(s)
- Diego Arroyo
- Cardiology, University and Hospital Fribourg, Fribourg, Switzerland
| | - Stéphane Cook
- Cardiology, University and Hospital Fribourg, Fribourg, Switzerland
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Madanchi M, Cioffi GM, Attinger-Toller A, Wolfrum M, Moccetti F, Seiler T, Vercelli L, Burkart P, Toggweiler S, Kobza R, Bossard M, Cuculi F. Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold. Open Heart 2021; 8:openhrt-2021-001776. [PMID: 34518287 PMCID: PMC8438862 DOI: 10.1136/openhrt-2021-001776] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/09/2021] [Accepted: 08/27/2021] [Indexed: 01/28/2023] Open
Abstract
Background Early studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes. Aims To evaluate long-term outcomes (up to 5 years) of patients with ISR treated with the Absorb BRS. Methods We did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT). Results Overall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3–77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years. Conclusions Treatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR.
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Affiliation(s)
- Mehdi Madanchi
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | | | | | - Mathias Wolfrum
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Federico Moccetti
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Thomas Seiler
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Luca Vercelli
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Philipp Burkart
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Stefan Toggweiler
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Richard Kobza
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Matthias Bossard
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Florim Cuculi
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
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Wiebe J, Hofmann FJ, West N, Baumbach A, Carrie D, Bermudez EP, Cayla G, Hernandez FH, de la Torre Hernandez JM, Koning R, Loi B, Moscarella E, Tarantini G, Zaman A, Lober C, Riemer T, Achenbach S, Hamm CW, Nef HM. Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium. Catheter Cardiovasc Interv 2021; 99:533-540. [PMID: 34463427 DOI: 10.1002/ccd.29932] [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] [Received: 06/13/2021] [Accepted: 08/21/2021] [Indexed: 01/22/2023]
Abstract
OBJECTIVES To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. BACKGROUND Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. METHODS The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. RESULTS A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. CONCLUSIONS The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.
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Affiliation(s)
- Jens Wiebe
- Department of Cardiology, Deutsches Herzzentrum Muenchen, Munich, Germany
| | - Felix J Hofmann
- Medizinische Klinik I, University of Giessen, Giessen, Germany
| | - Nick West
- Department of Cardiology, Royal Papworth Hospital, Cambridge, UK
| | | | - Didier Carrie
- Sevice de cardiologie, CHU Toulouse, Université Paul Sabatier, Toulouse, France
| | | | - Guillaume Cayla
- Service de cardiologie, CHU Nîmes, Université de Montpellier, Montpellier, France
| | | | | | - René Koning
- Département de Cardiologie, Clinique Saint-Hilaire, Rouen, France
| | - Bruno Loi
- Interventional Cardiology, Azienda Ospedaliera Brotzu, Cagliari, Italy
| | | | | | - Azfar Zaman
- Freeman Hospital and Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
| | - Christiane Lober
- IHF GmbH Institut für Herzinfarktforschung, Ludwigshafen, Germany
| | - Thomas Riemer
- IHF GmbH Institut für Herzinfarktforschung, Ludwigshafen, Germany
| | - Stephan Achenbach
- Department of Cardiology, Friedrich-Alexander-University of Erlangen, Erlangen, Germany
| | - Christian W Hamm
- Medizinische Klinik I, University of Giessen, Giessen, Germany.,Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim, Germany
| | - Holger M Nef
- Medizinische Klinik I, University of Giessen, Giessen, Germany
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Grimfjärd P, Bergman E, Buccheri S, Erlinge D, Lagerqvist B, Svennblad B, Völz S, Angerås O, James S. Outcome of PCI with Xience versus other commonly used modern drug eluting stents: A SCAAR report. Catheter Cardiovasc Interv 2021; 98:E197-E204. [PMID: 33719169 DOI: 10.1002/ccd.29641] [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: 11/28/2020] [Accepted: 02/25/2021] [Indexed: 11/07/2022]
Abstract
OBJECTIVES To analyze the clinical outcome of percutaneous coronary intervention (PCI) using the Xience drug eluting stent (DES) versus other modern DES. METHODS This retrospective study based on the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) analyzed the outcome of PCI using Xience versus other commonly used modern DES, 2007 to 2017. The primary outcome measure was a combination of all-cause death, myocardial infarction (MI) and revascularisation with PCI. Angiographical outcome measures were in-stent restenosis (ISR) and stent thrombosis (ST). RESULTS Rates of the primary outcome measure for Xience and other DES were 31.9% and 28.2% respectively, adjusted hazard ratio (HR) 0.99 (95% CI 0.95-1.03). Crude rates of ISR were 2.9% versus 2.1% over 4.3 and 2.9 years respectively, adjusted HR 0.93 (95% CI 0.81-1.06). Crude rates of ST were 0.9% versus 0.7%, adjusted HR 1.07 (95% CI 0.82-1.39). Results were consistent in all sensitivity analyses. CONCLUSIONS This nationally complete, real-world study confirms that Xience is a safe and effective DES with low-event rates of ISR and ST. Compared with a control group containing a large proportion of thinner strut stents and absorbable polymers, Xience exhibits similar results in all important clinical endpoints.
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Affiliation(s)
- Per Grimfjärd
- Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
- Department of Cardiology, Västerås Hospital, Västerås, Sweden
| | - Elin Bergman
- Department of Cardiology, Västerås Hospital, Västerås, Sweden
| | - Sergio Buccheri
- Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
- Uppsala Clinical Research Center, Uppsala, Sweden
| | - David Erlinge
- Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden
| | - Bo Lagerqvist
- Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
- Uppsala Clinical Research Center, Uppsala, Sweden
| | | | - Sebastian Völz
- Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden
| | - Oskar Angerås
- Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden
| | - Stefan James
- Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
- Uppsala Clinical Research Center, Uppsala, Sweden
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Mazaev VP. Poor past and look forward. КАРДИОВАСКУЛЯРНАЯ ТЕРАПИЯ И ПРОФИЛАКТИКА 2021. [DOI: 10.15829/1728-8800-2021-2930] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/01/2022] Open
Affiliation(s)
- V. P. Mazaev
- National Medical Research Center for Therapy and Preventive Medicine
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Alfonso F, Cuesta J, Rivero F. Dispositivos coronarios bioabsorbibles: ¿requiescant in pace? Rev Esp Cardiol 2021. [DOI: 10.1016/j.recesp.2020.11.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
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Wiebe J, Hoppmann P, Cassese S, Rheude T, Colleran R, Kuna C, Rai H, Valeskini M, Ibrahim T, Joner M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA. Evolución de pacientes tratados con armazones coronarios bioabsorbibles liberadores de everolimus tras su disolución completa. Rev Esp Cardiol 2021. [DOI: 10.1016/j.recesp.2020.06.041] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/22/2023]
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Li Y, Liang X, Zhang W, Qiao X, Wang Z. The Clinical and Angiographic Outcomes of Postdilation after Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: A Systematic Review and Meta-Analysis. J Interv Cardiol 2021; 2021:6699812. [PMID: 33935601 PMCID: PMC8055432 DOI: 10.1155/2021/6699812] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2020] [Revised: 03/01/2021] [Accepted: 03/23/2021] [Indexed: 12/18/2022] Open
Abstract
OBJECTIVE The effect of postdilation in patients with acute coronary syndrome is still controversial. This meta-analysis aims to analyze the clinical and angiographic outcomes of postdilation after percutaneous coronary intervention in patients with acute coronary syndrome. METHODS PubMed, Embase, the Cochrane Library, Web of Science, CNKI, and Wangfang databases were searched from inception to August 30, 2020. Eligible studies from acute coronary syndrome patients treated with postdilation were included. The primary clinical outcome was major adverse cardiovascular events (MACE), the secondary clinical outcomes comprised all-cause death, stent thrombosis, myocardial infarction, and target vessel revascularization, and the angiographic outcomes were no reflow and slow reflow. RESULTS 11 studies met inclusion criteria. In clinical outcomes, our pooled analysis demonstrated that the postdilation had a tendency of decreasing MACE (OR = 0.67, 95% CI 0.45-1.00; P = 0.05) but significantly increased all-cause death (OR = 1.49, 95% CI 1.05-2.12; P = 0.03). No significant difference existed in stent thrombosis (OR = 0.71, 95% CI 0.40-1.26; P = 0.24), myocardial infarction (OR = 1.40, 95% CI 0.51-3.83; P = 0.51), and target vessel revascularization (OR = 0.61, 95% CI 0.21-1.80; P = 0.37) between postdilation and non-postdilation groups. In angiographic outcomes, there were no significant differences in no reflow (OR = 1.19, 95% CI 0.54-2.65; P = 0.66) and slow reflow (OR = 1.12, 95% CI 0.93-1.35; P = 0.24) between two groups. CONCLUSIONS The postdilation tends to reduce the risk of MACE but significantly increases all-cause death, without significantly affecting stent thrombosis, myocardial infarction, target vessel revascularization, and coronary TIMI flow grade. However, more randomized controlled trials are required for investigating the effect of postdilation for patients with acute coronary syndrome (registered by PROSPERO, CRD42020160748).
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Affiliation(s)
- Yan Li
- The First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China
| | - Xiying Liang
- The First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China
| | - Wenjiao Zhang
- The First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China
| | - Xuan Qiao
- The First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China
| | - Zhilu Wang
- Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, Gansu, China
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Alfonso F, Cuesta J, Rivero F. Coronary bioresorbable vascular scaffolds: requiescant in pace? ACTA ACUST UNITED AC 2021; 74:569-572. [PMID: 33622635 DOI: 10.1016/j.rec.2020.11.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/10/2020] [Accepted: 11/20/2020] [Indexed: 10/22/2022]
Affiliation(s)
- Fernando Alfonso
- Servicio de Cardiología, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
| | - Javier Cuesta
- Servicio de Cardiología, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
| | - Fernando Rivero
- Servicio de Cardiología, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
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Nappi F, Nenna A, Larobina D, Martuscelli G, Singh SSA, Chello M, Ambrosio L. The Use of Bioactive Polymers for Intervention and Tissue Engineering: The New Frontier for Cardiovascular Therapy. Polymers (Basel) 2021; 13:446. [PMID: 33573282 PMCID: PMC7866823 DOI: 10.3390/polym13030446] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2020] [Revised: 01/19/2021] [Accepted: 01/25/2021] [Indexed: 12/28/2022] Open
Abstract
Coronary heart disease remains one of the leading causes of death in most countries. Healthcare improvements have seen a shift in the presentation of disease with a reducing number of ST-segment elevation myocardial infarctions (STEMIs), largely due to earlier reperfusion strategies such as percutaneous coronary intervention (PCI). Stents have revolutionized the care of these patients, but the long-term effects of these devices have been brought to the fore. The conceptual and technologic evolution of these devices from bare-metal stents led to the creation and wide application of drug-eluting stents; further research introduced the idea of polymer-based resorbable stents. We look at the evolution of stents and the multiple advantages and disadvantages offered by each of the different polymers used to make stents in order to identify what the stent of the future may consist of whilst highlighting properties that are beneficial to the patient alongside the role of the surgeon, the cardiologist, engineers, chemists, and biophysicists in creating the ideal stent.
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Affiliation(s)
- Francesco Nappi
- Department of Cardiac Surgery, Centre Cardiologique du Nord de Saint-Denis, 93200 Paris, France
| | - Antonio Nenna
- Department of Cardiovascular Surgery, Università Campus Bio-Medico di Roma, 00128 Rome, Italy; (A.N.); (M.C.)
| | - Domenico Larobina
- Institute for Polymers, Composites and Biomaterials, National Research Council of Italy, 06128 Rome, Italy; (D.L.); (L.A.)
| | - Giorgia Martuscelli
- Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania Luigi Vanvitelli, 81100 Naples, Italy;
| | | | - Massimo Chello
- Department of Cardiovascular Surgery, Università Campus Bio-Medico di Roma, 00128 Rome, Italy; (A.N.); (M.C.)
| | - Luigi Ambrosio
- Institute for Polymers, Composites and Biomaterials, National Research Council of Italy, 06128 Rome, Italy; (D.L.); (L.A.)
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Jang HG, Kim K, Park HW, Koh JS, Jeong YH, Park JR, Kang MG. Restenosis of a drug eluting stent on the previous bioresorbable vascular scaffold successfully treated with a drug-coated balloon: A case report. World J Clin Cases 2021; 9:758-763. [PMID: 33553417 PMCID: PMC7829740 DOI: 10.12998/wjcc.v9.i3.758] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/27/2020] [Revised: 12/22/2020] [Accepted: 12/30/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The in-stent restenosis (ISR) rates are reportedly inconsistent despite the increased use of second-generation drug eluting stent (DES). Although bioresorbable vascular scaffold (BVS) have substantial advantages with respect to vascular restoration, the rate of scaffold thrombosis is higher with BVS than with DES. Optimal treatment strategies have not been established for DES-ISR to date. CASE SUMMARY We report on a case of a 60-year-old man patient with acute coronary syndrome. He had a history of ST-segment elevation myocardial infarction associated with very late scaffold thrombosis and treated with a DES. Coronary angiography revealed significant stenosis, suggesting DES-ISR on the previous BVS. Optical coherence tomography (OCT) identified a plaque rupture and a disrupted scaffold strut in the neointimal proliferation of DES. To treat the DES-ISR on the previous BVS, we opted for a drug-coated balloon (DCB) after a balloon angioplasty using a semi-compliant and non-compliant balloon. The patient did not experience adverse cardiovascular events on using a DCB following the use of intensive dual antiplatelet therapy and statin for 24 mo. CONCLUSION This case highlights the importance of OCT as an imaging modality for characterizing the mechanism of target lesion failure. The use of a DCB following the administration of optimal pharmacologic therapy may be an optimal strategy for the treatment and prevention of recurrent BVS thrombosis and DES-ISR.
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Affiliation(s)
- Hyun Gyung Jang
- Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea
| | - Kyehwan Kim
- Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea
| | - Hyun Woong Park
- Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea
| | - Jin-Sin Koh
- Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea
| | - Young-Hoon Jeong
- Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, South Korea
| | - Jeong Rang Park
- Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea
| | - Min Gyu Kang
- Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea
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Inflammation as a determinant of healing response after coronary stent implantation. Int J Cardiovasc Imaging 2021; 37:791-801. [PMID: 33479786 PMCID: PMC7969567 DOI: 10.1007/s10554-020-02073-3] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/02/2020] [Accepted: 10/13/2020] [Indexed: 12/25/2022]
Abstract
Cardiovascular disease remains the leading cause of death and morbidity worldwide. Inflammation plays an important role in the development of atherosclerosis and is associated with adverse clinical outcomes in patients after percutaneous coronary interventions. Data on stent elements that lead to excessive inflammatory response, proper identification of high-risk patients, prevention and treatment targeting residual inflammatory risk are limited. This review aims to present the role of inflammation in the context of evolving stent technologies and appraise the potential imaging modalities in detection of inflammatory response and anti-inflammatory therapies.
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Wiebe J, Hofmann FJ, Dörr O, Bauer T, Boeder N, Liebetrau C, Blachutzik F, Möllmann H, Elsässer A, Achenbach S, Hamm CW, Nef HM. Five-year follow-up of patients who underwent everolimus-eluting bioresorbable scaffold implantation. Catheter Cardiovasc Interv 2021; 97:56-62. [PMID: 32187817 DOI: 10.1002/ccd.28843] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/25/2019] [Revised: 02/10/2020] [Accepted: 02/25/2020] [Indexed: 11/12/2022]
Abstract
OBJECTIVES The aim of this study was to evaluate very long-term results after unrestricted everolimus-eluting bioresorbable scaffolds (BRS) implantation. BACKGROUND Previous randomized studies mainly included selected patients differing from those seen during daily routine and long-term data from all-comers registries are sparse. METHODS Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including target-vessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC-defined scaffold thrombosis (ScT) were assessed. RESULTS A total of 176 patients with a median age of 64 (55 - 72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5 years, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2 years. CONCLUSIONS Although this real-world registry displays high rates of clinical events during long-term follow-up, no ScT was seen after 2 years.
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Affiliation(s)
- Jens Wiebe
- Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
| | - Felix J Hofmann
- Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany
| | - Oliver Dörr
- Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany
| | - Timm Bauer
- Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany
| | - Niklas Boeder
- Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany
| | - Christoph Liebetrau
- Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany
| | - Florian Blachutzik
- Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany
| | - Helge Möllmann
- Department of Internal Medicine I, St. Johannes-Hospital, Dortmund, Germany
| | | | - Stephan Achenbach
- Medizinische Klinik 2, Friedrich-Alexander Universität Erlangen-Nürnberg, Erlangen, Germany
| | - Christian W Hamm
- Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany.,Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany
| | - Holger M Nef
- Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany
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Verheye S, Vrolix M, Montorfano M, Zivelonghi C, Giannini F, Bedogni F, Dubois C, De Bruyne B, Costa RA, Chamié D, de Ribamar Costa J, Kereiakes DJ, Abizaid AA, Colombo A. Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system. EUROINTERVENTION 2020; 16:e974-e981. [PMID: 32894231 DOI: 10.4244/eij-d-20-00763] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
AIMS We aimed to assess the safety and efficacy of the DynamX Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements. METHODS AND RESULTS This multicentre study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Up to 12 months, two target lesion failures occurred: both were cardiac deaths (day 255 and day 267 post procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm in-device and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility, with an approximate lumen area variance of 11% between systole and diastole. CONCLUSIONS The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy up to one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomised trials are required to assess the benefit of this device on events beyond one year.
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Affiliation(s)
- Stefan Verheye
- Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium
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Onuma Y, Chevalier B, Ono M, Cequier À, Dudek D, Haude M, Carrié D, Sabaté M, Windecker S, Rapoza RR, West NEJ, Reith S, de Sousa Almeida M, Campo G, Íñiguez-Romo A, Serruys PW. Bioresorbable scaffolds versus everolimus-eluting metallic stents: five-year clinical outcomes of the randomised ABSORB II trial. EUROINTERVENTION 2020; 16:e938-e941. [PMID: 32515738 DOI: 10.4244/eij-d-20-00024] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Affiliation(s)
- Yoshinobu Onuma
- Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland
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Peng X, Qu W, Jia Y, Wang Y, Yu B, Tian J. Bioresorbable Scaffolds: Contemporary Status and Future Directions. Front Cardiovasc Med 2020; 7:589571. [PMID: 33330651 PMCID: PMC7733966 DOI: 10.3389/fcvm.2020.589571] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2020] [Accepted: 10/20/2020] [Indexed: 12/13/2022] Open
Abstract
Percutaneous coronary intervention, which is safe, effective, and timely, has become an important treatment for coronary artery diseases and has been widely used in clinical practice. However, there are still some problems that urgently need to be solved. Permanent vessel caging through metallic implants not only prevents the process of positive vessel remodeling and the restoration of vascular physiology but also makes the future revascularization of target vessels more difficult. Bioresorbable scaffolds (BRSs) have been developed as a potential solution to avoid the above adverse reactions caused by permanent metallic devices. BRSs provide temporary support to the vessel wall in the short term and then gradually degrade over time to restore the natural state of coronary arteries. Nonetheless, long-term follow-up of large-scale trials has drawn considerable attention to the safety of BRSs, and the significantly increased risk of late scaffold thrombosis (ScT) limits its clinical application. In this review, we summarize the current status and clinical experiences of BRSs to understand the application prospects and limitations of these devices. In addition, we focus on ScT after implantation, as it is currently the primary drawback of BRS. We also analyze the causes of ScT and discuss improvements required to overcome this serious drawback and to move the field forward.
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Affiliation(s)
- Xiang Peng
- Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.,The Key Laboratory of Myocardial Ischemia, Harbin Medical University, Ministry of Education, Harbin, China
| | - Wenbo Qu
- Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.,The Key Laboratory of Myocardial Ischemia, Harbin Medical University, Ministry of Education, Harbin, China
| | - Ying Jia
- Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.,The Key Laboratory of Myocardial Ischemia, Harbin Medical University, Ministry of Education, Harbin, China
| | - Yani Wang
- Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.,The Key Laboratory of Myocardial Ischemia, Harbin Medical University, Ministry of Education, Harbin, China
| | - Bo Yu
- Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.,The Key Laboratory of Myocardial Ischemia, Harbin Medical University, Ministry of Education, Harbin, China
| | - Jinwei Tian
- Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.,The Key Laboratory of Myocardial Ischemia, Harbin Medical University, Ministry of Education, Harbin, China.,Guangxi Key Laboratory of Diabetic Systems Medicine, Guilin Medical University, Guilin, China
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Buono A, Ielasi A, Colombo A. Latest generation stents: is it time to revive the bioresorbable scaffold? Minerva Cardioangiol 2020; 68:415-435. [DOI: 10.23736/s0026-4725.20.05188-9] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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