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Wu R, Yang Q, Wang M, Li Z, Yao C, Chang G. Safety and efficacy of chocolate balloon in the treatment of infrapopliteal artery disease. CVIR Endovasc 2025; 8:3. [PMID: 39776384 PMCID: PMC11707162 DOI: 10.1186/s42155-024-00501-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2024] [Accepted: 12/02/2024] [Indexed: 01/11/2025] Open
Abstract
OBJECTIVE To evaluate the safety and efficacy of chocolate balloons in patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, and compare them with conventional balloons. METHODS This single-center retrospective study included 167 patients with CLTI and infrapopliteal who underwent endovascular intervention with or without chocolate balloons from September 1, 2019 to June 30, 2023. The primary endpoint was amputation-free survival (AFS). Secondary endpoints included major amputation, the absence of clinically driven target lesion revascularization (CD-TLR), the incidence of flow-limiting dissection, below-the-knee (BTK) stent implantation, change in Rutherford clinical grade, procedural success, and major adverse cardiovascular events (MACEs). Patients were followed at 30 days, 6 months, and 12 months to assess symptom improvement, vascular patency as determined by dual-function ultrasound or angiography, and survival. RESULTS At 12 months, AFS was noted in 78.1% of patients in chocolate balloon group and 70.7% of those in conventional balloon group (p = 0.37). The chocolate balloon group demonstrated a significantly higher rate of CD-TLR absence, with 84.0% compared to 69.4% in the conventional balloon group (p = 0.04). The chocolate balloon group had a major amputation-free rate of 92.8%, slightly better than the 89.5% in the conventional balloon group (p = 0.58). Notably, the chocolate balloon group significantly reduced flow-limiting dissection (p = 0.02) and BTK stent implantation (p = 0.03) compared to the conventional balloon group. CONCLUSION Chocolate balloon reduces the incidence of flow-limiting dissection and BTK stent implantation in patients with CLTI and infrapopliteal. Compared with conventional balloons, there was less lesion revascularization at 12 months, but no significant benefit was found in improving ASF and reducing major amputation of the affected limb.
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Affiliation(s)
- Ridong Wu
- Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Qingqi Yang
- Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Mian Wang
- Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Zilun Li
- Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Chen Yao
- Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Guangqi Chang
- Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
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Fong KY, Xin L, Ng J, Loh SEK, Ng JJ, Choong AMTL. A systematic review and meta-analysis of sirolimus-eluting stents for treatment of below-the-knee arterial disease. J Vasc Surg 2023; 77:1264-1273.e3. [PMID: 36183989 DOI: 10.1016/j.jvs.2022.09.022] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2022] [Revised: 08/29/2022] [Accepted: 09/19/2022] [Indexed: 10/14/2022]
Abstract
OBJECTIVE We performed a systematic review and meta-analysis to analyze the efficacy and safety of sirolimus-eluting stents (SESs) in the treatment of below-the-knee (BTK) arterial disease. METHODS An electronic literature search was conducted from inception to July 24, 2021. Retrospective, prospective, and randomized studies that had used SESs to treat BTK arterial disease and had reported the primary patency, technical success, target lesion revascularization, and/or mortality were included. Meta-analyses of the proportions were conducted to derive pooled summary statistics of the outcomes. Where Kaplan-Meier curves were provided for primary patency, a meta-analysis of the individual patient data was conducted via a graphic reconstruction tool to estimate primary patency at various follow-up points. For studies comparing SESs and bare metal stents (BMSs), a two-stage meta-analysis was performed to compare the 6-month primary patency of SESs vs BMSs. RESULTS Ten studies across 13 publications, including 995 patients, were retrieved for analysis. In the meta-analysis of proportions, across six studies (n = 339 patients), the pooled 6-month primary patency was 87.3% (95% confidence interval [CI], 81.6%-92.1%). Across seven studies (n = 283 patients), the pooled 6-month mortality was 5.4% (95% CI, 1.4%-11.2%). An individual patient data analysis of three studies (n = 282 patients) yielded a primary patency rate of 95.2% (95% CI, 92.7%-97.8%), 82.8% (95% CI, 78.3%-87.6%), 79.8% (95% CI, 75.0%-85.0%), and 79.8% (95% CI, 75.0%-85.0%) at 6, 12, 18, and 24 months, respectively. The 12-month target lesion revascularization rate across four studies (n = 324 patients) was 9.6% (95% CI, 6.4%-13.4%). In the two-stage meta-analysis of 6-month primary patency across three studies (n = 168 patients), the use of SESs was significantly favored over BMSs (risk ratio, 1.28; 95% CI, 1.12-1.46; P < .001). CONCLUSIONS The overall evidence suggests that the use of SESs appears to be safe and offers favorable outcomes for BTK arterial disease compared with BMSs.
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Affiliation(s)
- Khi Yung Fong
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Liu Xin
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Magdalen College, University of Oxford, Oxford, UK
| | - Josiah Ng
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Stanley E K Loh
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Diagnostic Imaging, National University Health System, Singapore
| | - Jun Jie Ng
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore
| | - Andrew M T L Choong
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore; Cardiovascular Research Institute, National University of Singapore, Singapore.
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Cai H, Dong J, Ye Y, Song Q, Lu S. Safety and Efficacy of Drug-Coated Balloon in the Treatment of Below-The-Knee Artery: A Meta-analysis. J Surg Res 2022; 278:303-316. [PMID: 35660302 DOI: 10.1016/j.jss.2022.04.055] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2021] [Revised: 02/19/2022] [Accepted: 04/19/2022] [Indexed: 12/21/2022]
Abstract
INTRODUCTION Chronic limb threat ischemia is associated with cardiovascular events, resulting in high amputation, morbidity and mortality rates. This study aims to accomplish a comprehensive summary of randomized controlled trials and single-center trials related to drug-coated balloons (DCBs) in the treatment of below-the-knee (BTK) artery disease, and to provide a recommendation for the application of DCBs in BTK artery disease. METHODS Five electronic databases were used to retrieve relevant articles on the safety and effectiveness of DCBs in the treatment of BTK artery disease. A random-effects model was applied to calculate the standard mean deviation, odds ratio (OR) and their 95% of confidence interval (CI). RESULTS As of April 8, 2021, a total of 241 articles were retrieved, but only 13 articles were finally included for meta-analysis. The 12 mo follow-up study found that major adverse events , all-cause mortality, major amputation ,and target lesion revascularization had no statistically significant difference between the DCBs group and the control group (target lesion revascularization: OR = 0.68, 95% CI: 0.36, 1.31; all-cause mortality: OR = 1.30, 95% CI: 0.69, 2.46; major amputation: OR = 1.34, 95% CI: 0.64, 2.79; target lesion revascularization: OR = 0.72, 95% CI: 0.35, 1.45). CONCLUSIONS The meta-analysis results of randomized controlled trials focusing on comparing DCBs and other treatments suggest that DCBs do not have significant advantages in the treatment of BTK artery disease when compare with percutaneous transluminal angioplasty (PTA), but better than control intervention except PTA in both safety and efficacy end points. However, the results of meta-analysis of single-arm trial reported DCBs in treating BTK artery lesions are significantly improved compared with the meta-analysis concentrating on PTA.
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Affiliation(s)
- Hui Cai
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Jian Dong
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Yuanpeng Ye
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Qiang Song
- Department of Structural Heart Disease, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Shaoying Lu
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
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Gujja K, Nasiadko K, Tarricone A, Sanina C, Krishnan P. Below the Knee Interventions in Critical Limb Ischemia. Interv Cardiol 2022. [DOI: 10.1002/9781119697367.ch84] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022] Open
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Lysenko ER, Burov AI, Griaznov OG, Bushueva EV. [Use of endovascular drug-coated devices in lesions of femoropopliteoltibial arteries]. ANGIOLOGII︠A︡ I SOSUDISTAI︠A︡ KHIRURGII︠A︡ = ANGIOLOGY AND VASCULAR SURGERY 2021; 27:165-172. [PMID: 34528602 DOI: 10.33529/angiq2021305] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
Endovascular intervention is one of the main methods of treatment in atherosclerotic lesions of the infrainguinal segment in patients with chronic lower limb ischaemia. Recent years have witnessed active use of drug-eluting techniques, significantly improving the long-term outcomes of peripheral reconstructions. This article is a review of publications on the results of using modern drug-eluting balloon catheters and stents in the femoropopliteoltibial position. The accumulated data will help solve the main problems of the classic balloon angioplasty, reducing the incidence of restenosis, improving primary patency, and decreasing the need for repeat interventions in the remote period of follow-up.
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Affiliation(s)
- E R Lysenko
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
| | - A Iu Burov
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
| | - O G Griaznov
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
| | - E V Bushueva
- Department of Vascular Surgery, Centre of Cardiovascular and Endovascular Surgery, Federal Clinical Centre of High Medical Technologies of the Federal Medical and Biological Agency of the RF Ministry of Public Health, Khimki, Russia
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Supera Stent for Management of Occlusive Popliteal Artery Disease: an Indian Experience. Indian J Surg 2021. [DOI: 10.1007/s12262-020-02370-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022] Open
Abstract
Abstract
Introduction
Popliteal artery occlusion is common in elderly, smokers, and patients with diabetes, with globally rising incidence. Angioplasty and stenting are common treatment options available to manage lower limb occlusive diseases. As popliteal artery experiences high biomechanical stress, Supera stent is designed to reduce the risk of stent fractures and for better patency across the knee joint.
Aim & Objectives
The aim of this study is to evaluate the Supera stent in the management of popliteal artery occlusive disease. The objectives of this study are (1) to evaluate the efficacy of Supera stent in the management of popliteal artery occlusive disease and (2) to prove it as a relatively safe to use option.
Material & Methods
Patients who underwent stent implantation in popliteal artery were analyzed with regular/serial follow-up. Critical limb ischemia and intermittent claudication patients were included. Medical records, radiographs, and procedural data were examined. The patients were classified according to Trans-Atlantic Inter Society Consensus II criteria. The femoropopliteal lesions which were classified into TASC B and C categories were included in the study. Stents of 5 mm and 5.5 mm diameter and with various lengths were used to treat all the patients.
Results
A total number of patients with tissue loss and rest pain analyzed were eighty-six and all of them were treated by implanting stents in popliteal artery. In 71.4% of cases, the lesions were found in the proximal segment of the artery. In nearly 95% of cases, technical success was achieved with the use of single stent. The primary and assisted primary patency rates at 24 months were found to be 86.04% and 95.34%, respectively. Notwithstanding the stent placement at a region of high biomechanical stress, there was no case of stent fracture. The limb salvage rate was 100%. The patients who died due to unrelated causes within 90 days of procedure were two.
Conclusion
The present study demonstrated that Supera stent is a safe and effective procedure for treating claudication and limb ischemia due to popliteal artery disease.
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Zeller T, Micari A, Scheinert D, Baumgartner I, Bosiers M, Vermassen FEG, Banyai M, Shishehbor MH, Wang H, Brodmann M. The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes. JACC Cardiovasc Interv 2020; 13:431-443. [PMID: 32081236 DOI: 10.1016/j.jcin.2019.10.059] [Citation(s) in RCA: 61] [Impact Index Per Article: 12.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/29/2019] [Revised: 10/23/2019] [Accepted: 10/29/2019] [Indexed: 12/22/2022]
Abstract
OBJECTIVES The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial. BACKGROUND Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population. METHODS IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile. RESULTS Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile. CONCLUSIONS Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).
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Affiliation(s)
- Thomas Zeller
- Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
| | - Antonio Micari
- Department of Cardiology, Humanitas Gavazzeni Hospital, Bergamo, Italy
| | | | - Iris Baumgartner
- Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital, Bern, Switzerland
| | - Marc Bosiers
- Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium
| | | | - Martin Banyai
- Department of Angiology, University Hospital Zurich, Zurich, Switzerland
| | - Mehdi H Shishehbor
- Heart & Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, Ohio
| | | | - Marianne Brodmann
- Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria
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Spiliopoulos S, Vasiniotis Kamarinos N, Brountzos E. Current evidence of drug-elution therapy for infrapopliteal arterial disease. World J Cardiol 2019; 11:13-23. [PMID: 30705739 PMCID: PMC6354073 DOI: 10.4330/wjc.v11.i1.13] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2018] [Revised: 10/23/2018] [Accepted: 01/01/2019] [Indexed: 02/06/2023] Open
Abstract
New and sophisticated endovascular devices, such as drug-eluting stents (DES) and drug-coated balloons (DCB), provide targeted drug delivery to affected vessels. The invention of these devices has made it possible to address the reparative cascade of arterial wall injury following balloon angioplasty that results in restenosis. DESs were first used for the treatment of infrapopliteal lesions almost 20 years ago. More recently, however, DCB technology is being investigated to improve outcomes of endovascular below-the-knee arterial procedures, avoiding the need for a metallic scaffold. Today, level IA evidence supports the use of infrapopliteal DES for short to medium length lesions, although robust evidence that justifies the use of DCBs in this anatomical area is missing. This review summarizes and discusses all available data on infrapopliteal drug-elution devices and highlights the most promising future perspectives.
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Affiliation(s)
- Stavros Spiliopoulos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
| | - Nikiforos Vasiniotis Kamarinos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
| | - Elias Brountzos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
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Ozpak B, Bozok S, Cayir MC. Thirty-six-month outcomes of drug-eluting balloon angioplasty in the infrapopliteal arteries. Vascular 2018; 26:457-463. [PMID: 29466934 DOI: 10.1177/1708538118759416] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/07/2025]
Abstract
Objectives To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle-brachial index 0.4-0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014. Methods Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle-brachial index and Rutherford class. Results Both ankle-brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle-brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%. Conclusions Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.
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Affiliation(s)
- Berkan Ozpak
- 1 Department of Cardiovascular Surgery, Corlu State Hospital, Tekirdag, Turkey
| | - Sahin Bozok
- 2 Department of Cardiovascular Surgery, Faculty of Medicine, Bahcesehir University, Istanbul, Turkey
| | - Mustafa Cagdas Cayir
- 3 Department of Cardiovascular Surgery, Faculty of Medicine, Pamukkale University, Denizli, Turkey
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Bukka M, Rednam PJ, Sinha M. Drug-eluting balloon: design, technology and clinical aspects. ACTA ACUST UNITED AC 2018; 13:032001. [PMID: 29227279 DOI: 10.1088/1748-605x/aaa0aa] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
A drug-eluting balloon is a non-stent technology in which the effective homogenous delivery of anti-proliferative drugs is processed by the vessel wall through an inflated balloon. This is done to restore luminal vascularity in order to treat atherosclerosis, in-stent restenosis and reduce the risk of late thrombosis without implanting a permanent foreign object. The balloon technology relies on the concept of targeted drug delivery, which helps in the rapid healing of the vessel wall and prevents the proliferation of smooth muscle cells. Several drug eluting devices in the form of coated balloons are currently in clinical use, namely DIOR®, PACCOCATH®, SeQuent®Please and IN.PACT™. The device varies in terms of the material used for making the balloon, the coating techniques, the choice of coated drug and the release pattern of the drug at the site. This review gives an insight into the evolution, rationale and comparison of the marketed drug-eluting balloons. Here, different coating techniques have been analysed for the application and critical analysis of available DEB technologies, and a technical comparison has been done.
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Affiliation(s)
- Meenasree Bukka
- Department of Medical Devices, National Institute of Pharmaceutical Education and Research, Ahmedabad (NIPER-A) Palaj, Opp. Air Force Station, Gandhinagar-382355, Gujarat, India
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Singh P, Harper Y, Oliphant CS, Morsy M, Skelton M, Askari R, Khouzam RN. Peripheral interventions and antiplatelet therapy: Role in current practice. World J Cardiol 2017; 9:583-593. [PMID: 28824788 PMCID: PMC5545142 DOI: 10.4330/wjc.v9.i7.583] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/31/2017] [Revised: 04/13/2017] [Accepted: 04/24/2017] [Indexed: 02/06/2023] Open
Abstract
Peripheral arterial disease (PAD) is a common disorder associated with a high risk of cardiovascular mortality and continues to be under-recognized. The major risk factors for PAD are similar to those for coronary and cerebrovascular disease. Management includes exercise program, pharmacologic therapy and revascularization including endovascular and surgical approach. The optimal revascularization strategy, endovascular or surgical intervention, is often debated due to the paucity of head to head randomized controlled studies. Despite significant advances in endovascular interventions resulting in increased utilization over surgical bypass, significant challenges still remain. Platelet activation and aggregation after percutaneous transluminal angioplasty of atherosclerotic arteries are important risk factors for re-occlusion/restenosis and life-threatening thrombosis following endovascular procedures. Antiplatelet agents are commonly prescribed to reduce the risk of myocardial infarction, stroke and death from cardiovascular causes in patients with PAD. Despite an abundance of data demonstrating efficacy of antiplatelet therapy in coronary artery disease and cerebrovascular disease, there is a paucity of clinical information, clinical guidelines and randomized controlled studies in the PAD population. Hence, data on antiplatelet therapy in coronary interventions is frequently extrapolated to peripheral interventions. The aim of this review article is to elucidate the current data on revascularization and the role and duration of antiplatelet and anticoagulant therapy in re-vascularized lower limb PAD patients.
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Zhang J, Xu X, Kong J, Xu R, Fan X, Chen J, Zheng X, Ma B, Sun M, Ye Z, Liu P. Systematic Review and Meta-Analysis of Drug-Eluting Balloon and Stent for Infrapopliteal Artery Revascularization. Vasc Endovascular Surg 2017; 51:72-83. [PMID: 28103754 DOI: 10.1177/1538574416689426] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Background: Drug-eluting balloon (DEB) and drug-eluting stent (DES) have been proposed for the treatment of infrapopliteal artery disease. We performed a systematic review and meta-analysis of the current available studies investigating outcomes of DEB and DES in the treatment of infrapopliteal artery disease. Methods: Multiple databases were systematically searched to identify studies investigating the outcomes of DEB and DES in the treatment of patients with infrapopliteal artery disease. The quality of studies was assessed by Cochrane Collaboration method. The demographic data, risk factors, outcomes, and antiplatelet strategy were extracted. Results: Nine studies were identified with 707 and 606 patients in DEB/DES and standard percutaneous balloon angioplasty (PTA)/bare metal stenting (BMS) group, respectively. The risk of target lesion revascularization (TLR; odds ratio [OR] = 0.38, 95% confidence interval [CI]: 0.23-0.63, P < .01), restenosis rate (OR = 0.30, 95% CI: 0.18-0.50, P < .01), and amputation rate (OR = 0.49, 95% CI: 0.29-0.83, P < .01) significantly decreased in the DES group. The overall survival (OR = 0.86, 95% CI: 0.56-1.32, P = .50) was similar in DES and standard PTA/BMS group; TLR (OR = 0.59, 95% CI: 0.32-1.09, P = .09), restenosis rate (OR = 0.49, 95% CI: 0.11-2.14, P = .35), amputation rate (OR = 1.32, 95% CI: 0.51-3.40, P = .57), and overall survival (OR = 1.40, 95% CI: 0.72-2.71, P = .32) were similar in DEB and standard PTA group. Conclusion: The present meta-analysis suggests that compared with standard PTA/BMS, DES may decrease the risk of clinically driven TLR, restenosis rate, and amputation rate without any impact on mortality. However, DEB has no obvious advantage in the treatment of infrapopliteal disease. Due to the limitations of our study, more randomized controlled trials, especially those for DEB, are necessary.
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Affiliation(s)
- Jianbin Zhang
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Xiaojie Xu
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Jie Kong
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Rongwei Xu
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Xueqiang Fan
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
| | - Jie Chen
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
| | - Xia Zheng
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
| | - Bo Ma
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
| | - Mingsheng Sun
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
| | - Zhidong Ye
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
| | - Peng Liu
- Department of Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
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Gujja K, Nasiadko K, Tarricone A, Krishnan P. Below the Knee Interventions in Critical Limb Ischemia. Interv Cardiol 2016. [DOI: 10.1002/9781118983652.ch80] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022] Open
Affiliation(s)
- Karthik Gujja
- Icahn School of Medicine at Mount Sinai; New York NY USA
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Katsanos K, Spiliopoulos S, Paraskevopoulos I, Diamantopoulos A, Karnabatidis D. Systematic Review and Meta-analysis of Randomized Controlled Trials of Paclitaxel-Coated Balloon Angioplasty in the Femoropopliteal Arteries: Role of Paclitaxel Dose and Bioavailability. J Endovasc Ther 2016; 23:356-70. [PMID: 26823485 DOI: 10.1177/1526602815626557] [Citation(s) in RCA: 80] [Impact Index Per Article: 8.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
PURPOSE To provide a qualitative analysis and quantitative synthesis of randomized controlled trials (RCTs) investigating paclitaxel-coated balloons (PCBs) in the femoropopliteal artery. METHODS PubMed, EMBASE, AMED, Scopus, CENTRAL, online content, and abstracts from international meetings were last screened in April 2015 for eligible RCTs using the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool, and quality of evidence was evaluated with the GRADE system. Outcome measures included late lumen loss (LLL) at 6 months and event rates of major limb amputations, binary lesion restenosis, and target lesion revascularization (TLR). Pooled treatment effects were analyzed in a random effects model to account for clinical heterogeneity; the outcomes are presented as the rate ratios (RRs) and their 95% confidence intervals (CIs). Extensive meta-regression was performed to analyze potential confounders. The review was registered in the PROSPERO database (CRD42015023938; www.crd.york.ac.uk/PROSPERO). RESULTS Eleven RCTs with 1609 subjects (1403 claudicants and 206 patients with critical limb ischemia) with medium-length femoropopliteal lesions (mean range 5.1-11.9 cm) were included. There was consistently high-quality evidence supporting the clear superiority of PCBs in terms of reduced LLL (mean difference -0.89 mm, 95% CI -1.14 to -0.64, p<0.001), less binary restenosis (RR 0.47, 95% CI 0.37 to 0.61, p<0.001), and fewer TLR events (RR 0.33, 95% CI 0.22 to 0.49, p<0.001). Major amputations were rare in both active and control arms (pooled event rate: 0.7%, 95% CI 0.3% to 1.2%). Results were stable across all potential risk modifiers and in the presence of stents as well. There was high-quality evidence that the dose of paclitaxel was related to the magnitude of the treatment effect; standard dose (3.0-μg and 3.5-μg) PCBs were significantly more effective compared with low-dose 2-μg PCB in reducing both restenosis (RR 2.1, 95% CI 1.2 to 3.4, p<0.001) and TLR (RR 2.5, 95% CI 1.9 to 3.8, p<0.001). CONCLUSION PCBs reduce by more than half the rates of restenosis and TLR in the femoropopliteal artery regardless of stent placement. Biologic effect size may vary according to paclitaxel bioavailability.
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Affiliation(s)
- Konstantinos Katsanos
- Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London, UK Department of Interventional Radiology, Patras University Hospital, School of Medicine, Patras, Rion, Greece
| | - Stavros Spiliopoulos
- Department of Interventional Radiology, Patras University Hospital, School of Medicine, Patras, Rion, Greece
| | - Ioannis Paraskevopoulos
- Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London, UK
| | - Athanasios Diamantopoulos
- Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London, UK
| | - Dimitris Karnabatidis
- Department of Interventional Radiology, Patras University Hospital, School of Medicine, Patras, Rion, Greece
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Spiliopoulos S, Kitrou P, Katsanos K, Karnabatidis D. Current Phase II drugs under investigation for the treatment of limb ischemia. Expert Opin Investig Drugs 2015; 24:1447-58. [PMID: 26296189 DOI: 10.1517/13543784.2015.1081894] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
INTRODUCTION More than 20 million people in Europe suffer from peripheral arterial disease and nearly 3% develop critical limb ischemia (CLI). Without any medical treatment, CLI has poor prognosis, resulting in limb loss and high mortality rate. Until today, no systemic drug is available for the treatment of CLI and the gold standard method of treatment includes risk factor modification and open surgical or endovascular revascularization. Endovascular local drug delivery devices and novel antithrombotic agents, currently under investigation, aim to improve outcomes of revascularization procedures. The pioneering concept of therapeutic angiogenesis induced by gene and stem cell therapy has been proposed, in an attempt to increase ischemic tissue perfusion. AREAS COVERED This review summarizes local and systemic pharmacological treatment of CLI using endovascular or pharmaco-biological therapy and focuses on Phase II trials available for these drugs. EXPERT OPINION Novel endovascular technologies combining angioplasty and local drug-delivery continuously improve and will come to be standard of practice for the management of limb ischemia, while new antithrombotic agents will further improve outcomes. Therapeutic angiogenesis represents a safe and promising treatment option. The combination of revascularization with microcirculation improvement induced by gene or stem cell therapy could enhance limb salvage.
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Affiliation(s)
- Stavros Spiliopoulos
- a 1 Patras University Hospital, Department of Interventional Radiology , Patras 26504, Greece +30 2613 603 219;
| | - Panagiotis Kitrou
- a 1 Patras University Hospital, Department of Interventional Radiology , Patras 26504, Greece +30 2613 603 219;
| | - Konstantinos Katsanos
- b 2 Guy's and St Thomas' Hospitals, NHS Foundation Trust, Department of Interventional Radiology , London, UK
| | - Dimitris Karnabatidis
- a 1 Patras University Hospital, Department of Interventional Radiology , Patras 26504, Greece +30 2613 603 219;
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Spiliopoulos S, Pastromas G, Diamantopoulos A, Katsanos K. Efficacy of clopidogrel treatment and platelet responsiveness in peripheral arterial procedures. Expert Opin Pharmacother 2014; 15:2205-17. [PMID: 25162471 DOI: 10.1517/14656566.2014.953054] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
INTRODUCTION Long-term antiplatelet therapy with clopidogrel has been recommended in patients undergoing peripheral arterial procedures. Poor antiplatelet effect of clopidogrel or high on-clopidogrel platelet reactivity (HCPR) has been recently identified in patients with peripheral arterial disease (PAD). AREAS COVERED This review focuses on the use of clopidogrel and the phenomenon of HCPR in PAD patients treated for intermittent claudication or critical limb ischaemia (CLI). The authors summarize current guidelines and recommendations for use of clopidogrel following peripheral arterial procedures and explore the prevalence and clinical impact of HCPR in the PAD population. Underlying mechanisms of HCPR and relevant clinical and genetic factors are analyzed with particular attention to the potential utility of point-of-care platelet function testing (PFT). EXPERT OPINION Clopidogrel is a safe, effective and well-tolerated antiplatelet agent in PAD patients following peripheral arterial revascularization. Dual-antiplatelet therapy could also be considered after complex endovascular procedures. HCPR has been identified in more than 50% of PAD patients on clopidogrel and has been related with significantly increased re-intervention rates. Incidence of HCPR is significantly higher in patients with CLI, diabetes mellitus and chronic renal disease. Personalized antiplatelet therapy on the basis of PFT is an elegant emerging concept for optimization of platelet inhibition and potential identification of patients at increased risk of bleeding and warrants investigation in future large-scale trials.
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Mustapha JA, Diaz-Sandoval LJ. Management of Infrapopliteal Arterial Disease: Critical Limb Ischemia. Interv Cardiol Clin 2014; 3:573-592. [PMID: 28582081 DOI: 10.1016/j.iccl.2014.07.002] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/07/2023]
Abstract
According to the TransAtlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease, "there is increasing evidence to support a recommendation for angioplasty in patients with critical limb ischemia and infrapopliteal artery occlusion." Management of infrapopliteal artery disease starts with diagnosis using modern preprocedural noninvasive and invasive imaging. Interventionalists need to learn the role of chronic total occlusion cap analysis and collateral zone recognition in angiosome-directed interventions for management of critical limb ischemia and be familiar with equipment and device selection and a stepwise approach for endovascular interventions. Interventionalists need to know which crossing tools to use to successfully cross-complex chronic total occlusion caps.
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Affiliation(s)
- Jihad A Mustapha
- Department of Clinical Research, College of Osteopathic Medicine, Michigan State University, 5900 Byron Center Ave SW, Wyoming, MI 49519, USA; Department of Medicine, Metro Health Hospital, 5900 Byron Center Avenue, Southwest, Wyoming, MI 49519, USA.
| | - Larry J Diaz-Sandoval
- Department of Clinical Research, College of Osteopathic Medicine, Michigan State University, 5900 Byron Center Ave SW, Wyoming, MI 49519, USA; Department of Medicine, Metro Health Hospital, 5900 Byron Center Avenue, Southwest, Wyoming, MI 49519, USA
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Mustapha J, Diaz-Sandoval LJ. Balloon Angioplasty in Tibioperoneal Interventions for Patients With Critical Limb Ischemia. Tech Vasc Interv Radiol 2014; 17:183-96. [DOI: 10.1053/j.tvir.2014.08.007] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
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Percutaneous transluminal angioplasty versus primary stenting in infrapopliteal arterial disease: a meta-analysis of randomized trials. J Vasc Surg 2014; 59:1711-20. [PMID: 24836770 DOI: 10.1016/j.jvs.2014.03.012] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2013] [Accepted: 03/09/2014] [Indexed: 11/22/2022]
Abstract
BACKGROUND Percutaneous transluminal angioplasty (PTA) and primary stenting are commonly used endovascular therapeutic procedures for the treatment of infrapopliteal arterial occlusive disease. However, which procedure is more beneficial for patients with infrapopliteal arterial occlusive disease is unknown. METHODS AND RESULTS We performed a meta-analysis, searching PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, ISI Web of Knowledge, and relevant websites without language or publication date restrictions for randomized trials that compared primary stenting with PTA in patients with infrapopliteal arterial occlusive disease. The keywords were "stents," "angioplasty," "infrapopliteal," "tibial arteries," and "below knee." We selected immediate technical success, primary and secondary patency, limb salvage, and patient survival as the outcomes of this meta-analysis. On the basis of the inclusion criteria, we identified six prospective randomized trials. One-year outcomes did not show any significant differences between the PTA and primary stenting groups, respectively: technical success (93.3% vs 96.2%; odds ratio [OR], 0.59; 95% confidence interval [CI], 0.24-1.47; P = .25), primary patency (57.1% vs 65.7%; OR, 0.95; 95% CI, 0.35-2.58; P = .92), secondary patency (73.5% vs 57.6%; OR, 2.08; 95% CI, 0.81-5.34; P = .13), limb salvage (82.2% vs 87.5%; OR, 0.64; 95% CI, 0.29-1.41; P = .27), and patient survival (84.0% vs 87.5%; OR, 0.79; 95% CI, 0.40-1.55; P = .49). CONCLUSIONS For infrapopliteal arterial occlusive disease, primary stenting has the same 1-year benefits as PTA. There is insufficient evidence to support the superiority of either method. Primary stenting is associated with a trend toward higher primary patency and lower secondary patency. Further large-scale prospective randomized trials should produce more reliable results.
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Antoniou GA, Chalmers N, Kanesalingham K, Antoniou SA, Schiro A, Serracino-Inglott F, Smyth JV, Murray D. Meta-analysis of outcomes of endovascular treatment of infrapopliteal occlusive disease with drug-eluting stents. J Endovasc Ther 2013; 20:131-44. [PMID: 23581752 DOI: 10.1583/1545-1550-20.2.131] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022]
Abstract
PURPOSE To review emerging evidence regarding the use of bare metal (BMS) vs. drug-eluting stents (DES) in the treatment of infrapopliteal occlusive disease. METHODS A systematic review of the literature was undertaken to identify all studies comparing stent treatments of infragenicular vessels in patients with chronic lower limb ischemia. Validated methods to assess the methodological quality of the included studies were applied. Outcome data were pooled, and combined overall effect sizes were calculated using fixed or random effects models. The search identified 4 randomized clinical trials and 2 observational studies reporting on 544 patients (287 treated with DES and 257 treated with BMS). Data are presented as the odds ratio (OR) with 95% confidence interval (CI) and the number-needed-to-treat (NNT). RESULTS Primary patency, freedom from target lesion revascularization, and clinical improvement at 1 year were significantly higher in the DES recipients compared to patients treated with BMS (OR 4.511, 95% CI 2.897 to 7.024, p<0.001, NNT 3.5; OR 3.238, 95% CI 2.019 to 5.192, p<0.001, NNT 6.0; and OR 1.792, 95% CI 1.039 to 3.090, p=0.036, NNT 7.3, respectively). No significant differences in limb salvage and overall survival at 1 year were identified between the groups (OR 2.008, 95% CI 0.722 to 5.585, p=0.181; OR 1.262, 95% CI 0.605 to 2.634, p=0.535, respectively). Sensitivity analyses investigating the potential effects of study design and type of DES on the combined outcome estimates validated the results. CONCLUSION Our analysis has demonstrated superior short-term results with DES compared with BMS, expressed by increased patency and freedom from target lesion revascularization. The influence of this finding on clinical surrogate endpoints, such as limb salvage, remains unknown.
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Affiliation(s)
- George A Antoniou
- Department of Vascular and Endovascular Surgery, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, UK.
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Katsanos K, Spiliopoulos S, Diamantopoulos A, Karnabatidis D, Sabharwal T, Siablis D. Systematic review of infrapopliteal drug-eluting stents: a meta-analysis of randomized controlled trials. Cardiovasc Intervent Radiol 2013; 36:645-58. [PMID: 23435741 DOI: 10.1007/s00270-013-0578-2] [Citation(s) in RCA: 47] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2012] [Accepted: 01/13/2013] [Indexed: 02/08/2023]
Abstract
INTRODUCTION Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES. MATERIALS AND METHODS PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported. RESULTS Three RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall event-free survival (72.2 vs. 57.3 %; pooled RR = 1.26, 95 % CI = 1.10-1.44, p = 0.0006; NNT = 6.7). CONCLUSION DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency, decrease repeat procedures, improve wound healing, and prolong overall event-free survival.
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Affiliation(s)
- Konstantinos Katsanos
- Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London, SE1 7EH, UK.
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van Overhagen H, Spiliopoulos S, Tsetis D. Below-the-knee interventions. Cardiovasc Intervent Radiol 2013; 36:302-11. [PMID: 23354963 DOI: 10.1007/s00270-013-0550-1] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/09/2012] [Accepted: 12/13/2012] [Indexed: 02/05/2023]
Affiliation(s)
- H van Overhagen
- Department of Radiology, Hagaziekenhuis, Leyweg 275, 2545 CH, The Hague, The Netherlands.
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Krokidis M, Spiliopoulos S, Katsanos K, Sabharwal T. Peripheral applications of drug-coated balloons: past, present and future. Cardiovasc Intervent Radiol 2013; 36:281-91. [PMID: 22915325 DOI: 10.1007/s00270-012-0467-0] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/20/2012] [Accepted: 07/31/2012] [Indexed: 02/08/2023]
Abstract
Drug-coated balloon (DCB) technologies represent the latest and hottest development in the field of endovascular treatment of peripheral arterial disease. Initial experience with paclitaxel-coated balloon use in the femoral artery has demonstrated lower mid-term restenosis and superior mid-term clinical outcomes in terms of improved wound healing and reduced repeat angioplasty rates compared with standard balloon angioplasty. Many companies are presently developing and/or improving DCB catheters and therefore ongoing, technical improvements of the already existing platforms, new drugs, and innovative carriers are expected. The ongoing basic research studies and various multicenter randomized, controlled trials that are currently in progress will offer valuable scientific insights regarding the long-term effectiveness and other crucial issues, such as efficacy in various vascular beds, optimal balloon dosage, and post angioplasty antiplatelet therapy. Future applications of these devices also could include in-stent restenosis, anastomotic stenosis of surgical bypass, and benign stenoses of the central venous system. The authors envision that DCB angioplasty will evolve to a major paradigm shift in the endovascular treatment of occlusive vascular diseases.
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Affiliation(s)
- Miltiadis Krokidis
- Department of Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, 1st Floor Lambeth Wing, Lambeth Palace Road, London, SE1 7EH, UK.
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Paraskevopoulos I, Spiliopoulos S, Davlouros P, Karnabatidis D, Katsanos K, Alexopoulos D, Siablis D. Evaluation of below-the-knee drug-eluting stents with frequency-domain optical coherence tomography: neointimal hyperplasia and neoatherosclerosis. J Endovasc Ther 2013; 20:80-93. [PMID: 23391087 DOI: 10.1583/12-4091.1] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE To report the use of intravascular frequency-domain optical coherence tomography (FD-OCT) to detect and characterize in-stent neointimal tissue following infrapopliteal drug-eluting stent (DES) placement in patients suffering from critical limb ischemia. METHODS This prospective study included 12 patients (7 men; mean age 72.8±7.2 years) who had previously received 21 infrapopliteal sirolimus- or everolimus-eluting stents. The patients returned for regular angiographic follow-up or presented with clinical relapse of symptoms over a mean follow-up of 13.5±7.3 months (range 6-33), at which time FD-OCT imaging was performed. Study endpoints were technical imaging success, defined as successful FD-OCT acquisition and visualization of the arterial lumen and complete vessel wall, and the detection and characterization of in-stent neointimal hyperplasia according to widely accepted OCT criteria. RESULTS OCT imaging was successfully completed in 19 of the 21 stents. Binary in-stent restenosis (ISR>50%) was detected in 10/19 stents. Percent restenosis was higher after longer follow-up (60.6%±19.8% ≥1 year vs. 35.3%±20.6% <1 year, p=0.03) and in symptomatic vs. asymptomatic patients (61.5%±20.4% vs. 37.2%±19.3%, p=0.04). Neoatherosclerosis findings included lipid-laden neointima (16/19), neointimal neovascularization (13/19), neointimal calcifications (6/19), and thrombus (5/19); no cases of thin-cap fibroatheroma were identified. Neointimal calcifications were more frequent after ≥12 months of follow-up compared to <12 months (46.6% vs. 0%, p=0.02). CONCLUSION FD-OCT of the infrapopliteal arteries following DES placement is safe and feasible and may demonstrate features of developing neointimal neoatherosclerosis. The latter might play a key role as a mechanism of below-the-knee ISR and warrants further investigation.
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Affiliation(s)
- Ioannis Paraskevopoulos
- Department of Diagnostic and Interventional Radiology, Patras University Hospital, Patras, Greece.
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Spiliopoulos S, Fragkos G, Katsanos K, Diamantopoulos A, Karnabatidis D, Siablis D. Long-term outcomes following primary drug-eluting stenting of infrapopliteal bifurcations. J Endovasc Ther 2012; 19:788-96. [PMID: 23210878 DOI: 10.1583/jevt-12-3993r.1] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE To investigate the outcomes following primary deployment of drug-eluting stents (DES) for the treatment of infrapopliteal bifurcation lesions in patients suffering from critical limb ischemia (CLI). METHODS This was a retrospective study of a registry enrolling all patients suffering from chronic infrapopliteal artery disease and undergoing treatment of tibial bifurcation lesions with DES using 3 techniques: balloon and stent (single stent), T-shape double-stent, and culotte double-stent. The analysis included 39 CLI patients (32 men; mean age 69 ± 10 years) who underwent primary stenting of 41 infrapopliteal bifurcations. Most patients (29, 70.7%) were classified as Rutherford category 4. The mean lesion length was 31.3 ± 13.1 mm. The primary endpoints were amputation-free survival, target lesion revascularization (TLR)-free survival, angiographic 2-vessel primary patency (2VPP), and 1-vessel primary patency (1VPP). Secondary endpoints included survival and angiographic binary restenosis. A Cox regression analysis was performed to identify independent predictors influencing outcomes RESULTS Technical success was achieved in all cases. The mean clinical and angiographic follow-up intervals were 47.5 ± 14.8 and 17.5 ± 12.5 months, respectively. According to the Kaplan-Meier analysis, overall survival, amputation-free survival, and TLR-free survival estimates were 79.5%, 84.3%, and 58.0%, respectively, at 5 years. At 12, 24, and 36 months, the 2VPP rates were 77.2%, 47.5%, and 33.9%, and the 1VPP rates were 84.0%, 65.5%, and 54.5%, respectively. Binary restenosis rates were 26.4%, 57.3%, and 82.2% at 12, 24, and 36 months; restenotic lesions were mainly detected at the origin of the bifurcations. The regression model did not identify any independent predictors influencing outcome. CONCLUSION DES application for below-the-knee bifurcation lesions was safe and resulted in satisfactory long-term angiographic and clinical outcomes comparable to those reported following infrapopliteal endovascular treatment.
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Affiliation(s)
- Stavros Spiliopoulos
- Department of Diagnostic and Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
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