Paclitaxel-Coated Balloon for the Management of In-Stent Coronary Restenosis: An Updated Meta-Analysis and Trial Sequential Analysis

Background: Drug-coated balloons present a potentially advantageous therapeutic approach for managing coronary in-stent restenosis (ISR). However, the comparative benefits of paclitaxel-coated balloons (PCBs) over uncoated balloons (UCBs) remain unclear.

Aims: We conducted a systematic review and meta-analysis to evaluate and compare the clinical outcomes of patients treated with PCBs and UCBs.

Methods: We systematically searched PubMed, Embase, and Cochrane for studies comparing PCBs and UCBs in managing coronary ISR. We used a random-effects model to pool risk ratios (RRs) and their 95% confidence intervals (CIs). Statistical analyses were conducted using Review Manager 5.4.1. Heterogeneity was assessed using I² statistics. Quality and risk of bias were evaluated using the Cochrane Collaboration's tool.

Results: We included seven randomized controlled trials with 1349 patients, of whom 840 underwent percutaneous coronary intervention with PCB. In our pooled analysis, patients treated with PCB had lower risks of target lesion revascularization (RR 0.31, 95% CI 0.18-0.52; p < 0.01), target vessel revascularization (0.53, 0.42-0.67; p < 0.01), major adverse cardiac events (MACEs) (0.25, 0.16-0.38; p < 0.01), and myocardial infarction (MI) (0.59, 0.37-0.95; p = 0.03). However, there were no significant differences in all-cause mortality (0.79, 0.37-1.70; p = 0.54), cardiac death (0.46, 0.03-8.12; p = 0.60), while tendencies for a significant difference were found for target lesion failure (0.39, 0.13-1.11; p = 0.08), or stent thrombosis (0.21, 0.03-1.35 p = 0.10).

Conclusion: These findings suggest that PCBs are superior to UCBs regarding the occurrence of target lesion revascularization, target vessel revascularization, MACEs, and MI, but they do not differ in all-cause mortality, and cardiac death, while trends to significant differences favoring PCB were found to stent thrombosis and target lesion failure.