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

TL;DR

This study compares paclitaxel-coated and uncoated balloons for treating leg artery restenosis, finding that the coated balloons offer better short-term results without more risks.

Contribution

A meta-analysis of prospective trials showing PCBA's efficacy in reducing restenosis and improving outcomes for femoropopliteal in-stent restenosis.

Findings

PCBA reduced recurrent restenosis compared to UCBA.

PCBA improved primary patency and freedom from target lesion revascularization.

PCBA showed greater clinical improvement without increasing major adverse events.

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).

Figures