Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Coronary In-Stent Restenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

In-stent restenosis (ISR) accounts for 10% of percutaneous coronary intervention (PCI) in the United States. Paclitaxel-coated balloons (PCBs) have been evaluated as a therapy for coronary ISR in multiple randomized controlled trials (RCTs). We searched PubMed/MEDLINE, Cochrane Library, and ClinicalTrials.gov (from inception to April 1, 2024) for RCTs evaluating PCBs versus uncoated balloon angioplasty (BA) in patients with coronary ISR. The outcomes of interest were target lesion revascularization (TLR), major adverse cardiovascular events (MACEs), all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and stent thrombosis. We pooled the estimates using an inverse variance random-effects model. The effect sizes were reported as risk ratio (RR) with 95% confidence interval (CI). A total of 6 RCTs with 1,343 patients were included. At a follow-up ranging from 6 to 12 months from randomization, the use of PCBs was associated with a statistically significant decrease in TLR (RR 0.28, 95% CI 0.11 to 0.68) and MACE (RR 0.35, 95% CI 0.20 to 0.64) compared with BA for coronary ISR. However, there was no significant difference in risk between PCBs and BA in terms of all-cause mortality (RR 0.56, 95% CI 0.14 to 2.31), cardiovascular mortality (RR 0.61, 95% CI 0.02 to 16.85), MI (RR 0.60, 95% CI 0.27 to 1.31), and stent thrombosis (RR 0.13, 95% CI 0.00 to 5.06). In conclusion, this meta-analysis suggests that PCBs compared with uncoated BA for the treatment of coronary ISR at intermediate-term follow-up of 1 year were associated with a significant decrease in TLR and MACE without any difference in mortality, MI, or stent thrombosis.