Drug-Coated Balloons for Revascularization of Infrapopliteal Arteries: A Meta-Analysis of Randomized Trials
Salvatore Cassese1, Gjin Ndrepepa1, Francesco Liistro2
1Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Insights
Drug-coated balloons (DCBs) show similar clinical outcomes for infrapopliteal artery disease compared to other treatments. However, DCBs demonstrated improved angiographic results, specifically reduced late lumen loss, in this meta-analysis.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- The efficacy of drug-coated balloons (DCBs) for treating atherosclerotic disease in infrapopliteal arteries is debated.
- Percutaneous revascularization aims to restore blood flow in narrowed or blocked arteries.
Purpose of the Study:
- To conduct a meta-analysis of randomized trials evaluating DCBs for infrapopliteal artery atherosclerotic disease.
- To compare the clinical and angiographic outcomes of DCB treatment versus control therapies.
Main Methods:
- A systematic search of scientific databases identified relevant randomized trials.
- Primary outcomes included target lesion revascularization and amputation; secondary outcomes included death, major adverse events, Rutherford class, and late lumen loss.
- Data from 5 trials involving 641 patients (378 DCB, 263 control) were analyzed with a median 12-month follow-up.
Main Results:
- DCB treatment showed comparable risks for target lesion revascularization, amputation, death, major adverse events, and Rutherford class 5 or 6 compared to control therapies.
- Patients treated with DCBs exhibited significantly lower late lumen loss compared to those receiving control therapy (WMD -0.41; 95% CI: -0.79 to -0.03; p=0.04).
Conclusions:
- DCBs offer similar clinical outcomes to uncoated balloons or drug-eluting stents for infrapopliteal artery revascularization at 1-year follow-up.
- DCBs demonstrated favorable angiographic efficacy, evidenced by reduced late lumen loss.
- Larger studies are required to fully establish the role of DCB technology in treating infrapopliteal arterial disease.
Objectives:
The aim of this study was to perform a meta-analysis of randomized trials investigating the outcomes of patients undergoing percutaneous revascularization with drug-coated balloons (DCBs) for atherosclerotic disease of the infrapopliteal arteries.
Background:
The role of DCBs as revascularization therapy for infrapopliteal arteries represents a matter of ongoing controversy.
Methods:
Scientific databases were searched for randomized trials of DCB therapy for atherosclerotic disease of the infrapopliteal arteries. The primary efficacy and safety outcomes were target lesion revascularization and amputation, respectively. Secondary outcomes were death, major adverse events, Rutherford class 5 or 6, and late lumen loss.
Results:
A total of 641 patients enrolled in 5 trials received DCBs (n = 378) or control therapy (uncoated balloons or drug-eluting stents; n = 263). Median follow-up duration was 12 months. Patients treated with DCBs had risk for target lesion revascularization (risk ratio: 0.71; 95% confidence interval [CI]: 0.47 to 1.09; p = 0.12), amputation (risk ratio: 1.01; 95% CI: 0.65 to 1.58; p = 0.95), death (risk ratio: 1.14; 95% CI: 0.71 to 1.82; p = 0.59), major adverse events (risk ratio: 0.92; 95% CI: 0.59 to 1.43; p = 0.70), and Rutherford class 5 or 6 (risk ratio: 0.87; 95% CI: 0.46 to 1.62; p = 0.65) comparable with that of patients treated with control therapy. Lesions treated with DCBs showed lower late lumen loss (weighted mean difference -0.41; 95% CI: -0.79 to -0.03; p = 0.04) compared with those treated with control therapy.
Conclusions:
In comparison with uncoated balloons or drug-eluting stents, the treatment of infrapopliteal arteries with DCBs is associated with similar clinical outcomes and favorable angiographic efficacy at 1-year follow-up. Further studies in larger numbers of patients are still needed to definitively address the role of DCB technology in this setting. (Drug-coated balloon for revascularization of tibialpedal arteries: a meta-analysis of randomized trials; CRD42015029283).
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