Benefit and Risk from Paclitaxel-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Abstract

Background: Paclitaxel-coated balloons (DCB) are suitable to reduce the risk of restenosis after angioplasty of atherosclerotic femoropopliteal lesions. However, numerous types of DCBs are distinguished by drug density and coating. Conflicting evidence exists about the risk of all-cause death. Methods: Randomised trials published between Jan 1, 2005 and Feb 3, 2019 were identified by searching MEDLINE, CENTRAL, and Clinical.trials.gov. Studies on DCB versus plain old balloon angioplasty (POBA) for the treatment of femoropopliteal artery disease were included, and those focused on in-stent restenosis or critical limb ischemia were excluded. Random-effects meta-analysis was conducted to assess the main outcomes of freedom from target lesion revascularisation (FfTLR) and all-cause mortality. Findings: Of 552 identified records, 14 studies including 2504 patients were eligible. DCB significantly increased the probability of FfTLR with substantial heterogeneity (12-month: risk ratio [RR] 1·24 [95% CI 1·14- 2·27], I2 = 66%; 24-month RR 1·39 [95% CI 1·39-1·52], I2 = 21%). The risk of all-cause mortality was similar between groups at 12 months (RR 0·87 [95% CI 0·48-1·59]), and non-significantly increased after DCB angioplasty at 24 months (RR 1·53 [95% CI 0·94-2·50]). Interpretation: Efficacy of DCB for femoropopliteal angioplasty differs substantial across studies. Effect size depends on the type of DCB, treatment strategy, and lesion complexity. The risk of all-cause death at two years tended to be increased after DCB without evidence of causation. Trial Registration Number: This study is registered with ClinicalTrials.gov (NCT02927574). Funding Statement: The authors stated: There was no funding source for this study. Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: This systematic review and meta-analysis was conducted according to the Preferred Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.