BMC Cardiovasc Disord. 2026 Oct 22;26(1):965. doi: 10.1186/s12872-026-06811-8.
ABSTRACT
BACKGROUND AND AIM: Drug-coated balloons (DCBs) are a key alternative to drug-eluting stents for coronary artery interventions, offering the advantage of drug delivery without permanent implants. Both paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs) are valuable treatment options. This systematic review and meta-analysis compare the efficacy and safety of sirolimus-coated versus paclitaxel-coated balloon catheters in patients with coronary artery disease.
METHODS: We conducted a systematic review and meta-analysis following PRISMA guidelines, searching five databases. We exclusively included RCTs. Risk ratios (RR) and mean differences (MD) with 95% confidence intervals were calculated using fixed-effects or random-effects models, with sensitivity analysis performed in cases of heterogeneity.
RESULTS: Eight trials involving 1043 patients were included. The meta-analysis demonstrated no significant difference between SCB and PCB for late lumen loss (MD 0.06, 95% CI [-0.02 to 0.14]). Only two outcomes showed statistically significant differences favoring PCB: reducing late lumen enlargement (RR 0.66, 95% CI [0.49-0.87], P = 0.004) and, after sensitivity analysis, lowering binary restenosis rates in de novo lesions CONCLUSION: This meta-analysis shows SCB and PCB have similar safety and efficacy in coronary artery interventions, with no significant differences in most outcomes. However, PCB outperforms late lumen enlargement and binary restenosis rates in de novo lesions. Similar outcomes across sirolimus formulations indicate other factors influence success. Both balloon types appear safe and effective, though PCB may retain certain advantages in specific scenarios. Larger, longer-term studies are needed to establish the optimal drug-coated balloon strategy for different patient populations.
CLINICAL TRIAL NUMBER: not applicable.
PMID:42919160 | DOI:10.1186/s12872-026-06811-8