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.