Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. SYSTEMATIC REVIEW REGISTRATION: This work was registered in PROSPERO, the international prospective register of systematic reviews (number: CRD42021261574).