Head to head comparison of limus vs paclitaxel-coated balloons (DCBs) in the treatment of in-stent restenosis: a meta-analysis

Background There is a significant trend in the use of drug coated balloons (DCBs) for the treatment of in-stent restenosis (ISR). However, there is a lack of robust comparative data between –limus drug coated balloons (DCBs) vs paclitaxel coated balloons (PCBs) on the efficacy and safety in treating ISR. Aims The objective of this systematic review and meta-analysis was to compare the efficacy and safety of -limus DCBs vs PCBs in terms of clinical and angiographic outcomes during a 12-month follow-up. Methods Following PRISMA guidelines, we systematically explored PubMed, SCOPUS, and Cochrane databases up to August 9, 2024, for studies comparing –limus DCBs vs PCBs in terms of safety, efficacy and angiographic outcomes in treating ISR. The primary outcomes were the incidence of clinically driven target lesion revascularization (TLR) and failure (TLF). Secondary endpoints were major adverse cardiovascular events (MACE) and angiographic findings during follow up. Results Data from six RCTs, including a total of 639 patients treated with limus DCBs and 569 with PCBs for ISR, were analyzed with a mean follow-up of 12 months. In this analysis, all six RCTs reported on TLR incidence, showing no significant difference between the limus DCB and PCB groups (14% vs. 11.4%, RR: 1.16, 95% CI: 0.82-1.64, I2=14%). Similarly, TLF rates were comparable between the two groups (15% vs. 14%, RR: 1.14, 95% CI: 0.86-1.53, I2=0%). Procedural success rates were high and similar (limus DCB: 100% vs. PCB: 99.5%). No significant differences were observed in MACEs (16.4% vs. 13.5%, RR: 1.11, 95% CI: 0.84-1.46, I2=0%), all-cause mortality (1.8% vs. 1.4%, RR: 1.25, 95% CI: 0.50-3.08, I2=0%), cardiac death (1.4% vs. 1%, RR: 1.19, 95% CI: 0.42-3.41, I2=0%), or target vessel myocardial infarction (TVMI) (0.9% vs 1%; RR: 0.58; 95% CI: 0.20-1.67, I2=0%). Angiographic outcomes showed no significant difference in post-intervention minimum luminal diameter (MLD) (SMD: +0.06, 95% CI: -0.07 to 0.18, I2=0%) and binary restenosis (19.5% vs 12.9%; RR: 1.45; 95% CI: 0.77-2.71, I2=63%) at follow-up between the groups. The risk of late lumen loss (LLL) was also comparable between limus DCB and PCB for in-segment analysis (SMD: 0.02, 95% CI: -0.18 to 0.23; I2=32%) and for in-lesion (SMD:-0.03, 95% CI: -0.31 to 0.24; I2=27%). Low heterogeneity was observed across the studies. Conclusion Our findings suggest that limus-DCBs are equally effective and safe as PCBs for treating ISR, demonstrating non-inferiority in both clinical and angiographic outcomes at 12 months post-intervention.