Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease: A meta-analysis of randomized trials

Wu, Ridong; Tang, Shi; Wang, Mian; Li, Zilun; Yao, Chen; Wang, Shenming

doi:10.1016/j.ijsu.2016.09.014

Cited by 18 publications

(9 citation statements)

References 19 publications

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“…A previous meta-analysis of 3 RCTs comparing DCB with BA exclusively in patients with CLTI and infrapopliteal lesions demonstrated no difference between the groups in terms of major adverse events (ie, death, major amputation, Rutherford category ≥4), TLR, or late restenosis; however, the degree of stenosis was less severe for the DCB group. 59 Similarly, in our study, sensitivity analyses among patients with infrapopliteal lesions demonstrated that the 12-month primary patency, TLR, major amputation, and mortality were not different between the DCB and BA groups, indicating that although reocclusions occurred less frequently among patients treated with DCBs there was still a need for TLR. Additionally, our meta-analysis provided very similar results to the recent preliminary 6-month study with Lutonix DCB (12.1% TLR, 8.8% mortality, and 2.9% major amputation), supporting the conclusion that DCB angioplasty appears safe for infrapopliteal lesions but has uncertain efficacy.…”

Section: Discussionsupporting

confidence: 70%

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

et al. 2020

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Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

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Section: Discussionsupporting

confidence: 70%

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

et al. 2020

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“…The RCTs comparing paclitaxel coated balloons with standard PTA were BIOLUX P-II, 10 IN.PACT DEEP, 11 DEBATE-BTK, 12 Lutonix BTK, 34 as well as a trial by Haddad et al including a total of 1097 patients. 35 Twelve month mortality was reported as 9.4% vs. 6 36 Similarly, a Cochrane analysis from 2016 including femoropopliteal and BK interventions did not find any significant difference for amputation or death in a subgroup analysis of BK and CLTI patients at 12 month follow up. 37 In contrast, this PS matched cohort revealed a PCX related reduction of all cause mortality, lower risk of amputation or death, and lower risk of cardiovascular Table 2.…”

Section: Discussionmentioning

confidence: 97%

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Heidemann

Peters

Kuchenbecker

et al. 2020

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS In this retrospective cohort study of 14 738 patients and 6 568 propensity score matched patients with index revascularisation below the knee between 1 January 2010 and 31 December 2018, a reduction was observed in long term all cause mortality and the combined endpoints of amputation or death and cardiovascular event or death five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia. The study addressed a key question in vascular medicine and using long term real world evidence does not confirm the potential harm reported in randomised controlled trials. Objective: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent metaanalysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. Methods: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the KaplaneMeier method and Cox regression. Results: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78e0.91), amputation or death (HR 0.87, 95% CI 0.81e0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80e0.92) were observed. Conclusion: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.

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“…Current clinical treatments primarily involve medical therapy (thrombolytic drugs and vasodilator drugs [1]) and surgery [2]. However, it remains difficult to achieve the purpose of vascular remodeling using either drugs [3] or surgery [4]. Inspired by the fact that the body undergoes natural angiogenesis in response to an insufficient blood supply, scientists have learned to enhance the efficiency of angiogenesis as a treatment strategy.…”

Section: Introductionmentioning

confidence: 99%

Therapeutic angiogenesis using stem cell-derived extracellular vesicles: an emerging approach for treatment of ischemic diseases

Bian

Zhang

et al. 2019

Stem Cell Res Ther

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Ischemic diseases, which are caused by a reduction of blood supply that results in reduced oxygen transfer and nutrient uptake, are becoming the leading cause of disabilities and deaths. Therapeutic angiogenesis is key for the treatment of these diseases. Stem cells have been used in animal models and clinical trials to treat various ischemic diseases. Recently, the efficacy of stem cell therapy has increasingly been attributed to exocrine functions, particularly extracellular vesicles. Extracellular vesicles are thought to act as intercellular communication vehicles to transport informational molecules including proteins, mRNA, microRNAs, DNA fragments, and lipids. Studies have demonstrated that extracellular vesicles promote angiogenesis in cellular experiments and animal models. Herein, recent reports on the use of extracellular vesicles for therapeutic angiogenesis during ischemic diseases are presented and discussed. We believe that extracellular vesicles-based therapeutics will be an ideal treatment method for patients with ischemic diseases.

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Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease: A meta-analysis of randomized trials

Cited by 18 publications

References 19 publications

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Therapeutic angiogenesis using stem cell-derived extracellular vesicles: an emerging approach for treatment of ischemic diseases

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