Paclitaxel-coated balloon catheter versus paclitaxel-eluting stent for the treatment of coronary in-stent restenosis: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials.

BACKGROUND

Paclitaxel is an antimicrotubular agent and is used to coat balloons and stents used in percutaneous coronary intervention. This study aims to provide a pooled comparison of paclitaxel-coated balloons (PCB) and paclitaxel-eluting stents (PES) in terms of their efficacy in treating restenosis and their associated safety outcomes.

METHODS

We systematically searched PubMed, Scopus, Science Direct, and Clinicaltrials.gov from inception until August 2024 to evaluate the outcomes between PCB and PES for treating coronary in-stent restenosis. Studies were deemed eligible if they compared PCB with PES in patients with coronary in-stent restenosis. Pooled data were reported using risk ratio (RR) for dichotomous outcomes and mean difference for continuous outcomes, along with 95% confidence intervals (CI). This systematic review and meta-analysis was registered with International Prospective Register of Systematic Reviews (CRD42024543509).

RESULTS

734 patients across 4 trials were included in this analysis. Descriptive analysis showed high device success in both groups (99.6% for PCB vs 97.9% for PES), while restenosis occurred in 20.6% of PCB patients and 23.7% of PES patients. Myocardial infarction rates were 1.9% for PCB and 3.0% for PES, while mortality was observed in 1.6% and 3.6% of patients, respectively. No significant differences between PCB and PES were revealed in terms of recurrent binary restenosis rates (RR: 0.76; 95% CI: 0.19 to 2.99) or late lumen loss (mean difference: -0.02; 95% CI: -0.25 to 0.22). Device success rates (RR: 1.01; 95% CI: 0.91 to 1.13), the incidence of myocardial infarction (RR: 0.64; 95% CI: 0.24 to 1.69), and the incidence of death (RR: 0.48; 95% CI: 0.16 to 1.41) were also comparable between the 2 groups.

CONCLUSION

PCB provides a viable stent-free alternative to PES with comparable outcomes. Further studies, especially those focused on assessing patient-specific factors and lesion characteristics are required to guide optimal treatment selection.