Paclitaxel-Coated versus Uncoated Balloon for Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis.

Abstract

Several prospective controlled trials to date have assessed the safety and efficacy of paclitaxel-coated balloon angioplasty (PCBA) versus uncoated balloon angioplasty (UCBA) for femoropopliteal (FP) in-stent restenosis (ISR). Therefore, this meta-analysis of prospective controlled trials aimed to summarize the results of these trials and present reliable conclusions. We systematically searched the PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, and CNKI databases for prospective randomized controlled trials (published between January 1, 2008, and July 31, 2021; no language restrictions) comparing PCBA with UCBA in the management of FP ISR. The main endpoints were recurrent restenosis, primary patency, freedom from target lesion revascularization (TLR), clinical improvement, ankle-brachial index (ABI), and major adverse events (MAEs). We assessed the pooled data using a fixed effects model. Of the 206 identified studies, seven were eligible and included in our analysis (N = 593 participants). Compared with UCBA, PCBA yielded a reduction in recurrent restenosis (odds ratio [OR], 0.22; 95% confidence interval [CI], 0.13-0.38), a better primary patency (OR, 3.59; 95% CI, 1.72-7.47), an improved likelihood of freedom from TLR (OR, 2.70; 95% CI, 1.36-5.35), greater clinical improvement (OR, 2.38; 95% CI, 1.50-3.79), and a similar mean difference in ABI (0.02; 95% CI, -0.11-0.14) and OR in MAEs (0.71; 95% CI, 0.24-2.14). PCBA as a treatment strategy can achieve better short-term outcomes of FP ISR management, including potent recurrent restenosis-lowering and symptom-improving capacity without increased MAEs. Therefore, it is a promising therapeutic strategy for patients with FP ISR. This work was registered in PROSPERO, the international prospective register of systematic reviews (number: CRD42021261574).