Efficacy of paclitaxel-coated versus uncoated balloon angioplasty for revascularization of coronary in-stent restenosis: a meta-analysis and metaregression

Author Department

Medicine; Cardiology

Document Type

Article, Peer-reviewed

Publication Date

5-2025

Abstract

Background: Treatment of in-stent restenosis (ISR) accounts for 10% of percutaneous coronary interventions in the USA. Paclitaxel-coated balloons (PCBs) are an alternative to uncoated balloons (UCBs) for ISR.

Methods: We systematically searched PubMed, Scopus, and Cochrane Central for studies comparing PCB with UCB in treating ISR. Outcomes included late lumen loss, binary restenosis, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE).

Results: Eight trials including 1410 patients [PCB in 865 (61%), follow-up 6 months to 10 years) were identified. Angiographic outcomes of late lumen loss [mean difference: -0.50 mm; 95% confidence interval (CI): -0.66 to -0.33; P < 0.01] and binary restenosis [relative risk (RR): 0.22; 95% CI: 0.13-0.40; P < 0.01] at 6-8 months were lower with PCB. TLR at 6 months (RR: 0.16; 95% CI: 0.06-0.40; P < 0.001) and 1 year (RR: 0.45; 95% CI: 0.31-0.66; P < 0.001), MACE at 6 months (RR: 0.25; 95% CI: 0.16-0.38; P < 0.001), MACE at 3-5 years (RR: 0.54; 95% CI: 0.37-0.80; P = 0.002), and TLR at 3-5 years (RR: 0.51; 95% CI: 0.29-0.90; P = 0.021) were lower with PCB. Meta-regression revealed that ISR lesions in the left anterior descending artery were associated with lower rates of binary restenosis while the opposite was observed for left circumflex lesions.

Conclusion: Revascularization of coronary ISR with PCB is associated with reduced late lumen loss, binary restenosis, TLR, CCE, and MACE. PCB may be a preferred strategy for coronary ISR.

Keywords: balloon angioplasty; coronary artery disease; drug-coated balloon; in-stent restenosis; paclitaxel-coated balloon.

PMID

40365645

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