Assessing paclitaxel-coated vs sirolimus-coated balloon angioplasty for coronary artery diseases: A systematic review and meta-analysis.

Abstract

Background: Given the clinical challenges posed by drug-eluting stents, drug-coated balloons offer a promising alternative by delivering antiproliferative medications directly to the vessel wall.

Aim: To compare the efficacy of paclitaxel-coated balloon (PCB) angioplasty vs sirolimus-coated balloon (SCB) angioplasty in the treatment of coronary artery disease (CAD), focusing on both in-stent restenosis (ISR) and de-novo lesions (DNL).

Methods: A comprehensive literature search on PubMed, EMBASE, and Cochrane Central from inception to 5^th February 2025. Only randomized controlled trials and observational studies comparing outcomes of PCB vs SCB angioplasty in patients with ISR or DNL were included.

Results: A total of nine studies with 1981 patients (949 in PCB arm and 1032 in SCB arm) were included for further quantitative analysis. The results indicated that both PCB and SCB angioplasty are effective in treating CAD, with PCB showing a greater minimal lumen diameter for DNL [mean difference: -0.11 (95% confidence interval: -0.22 to -0.01, P = 0.03)]. However, the risk of target lesion revascularization and diameter stenosis was identical for both PCB and SCB during the 9-12-month follow-up period.

Conclusion: This meta-analysis highlights that PCB angioplasty may offer superior angiographic outcomes compared to SCB angioplasty, specifically in achieving greater minimal lumen diameter in patients with DNL. These findings suggest that while PCB has certain advantages in terms of tissue retention and immediate efficacy, both PCB and SCB are viable options for treating ISR or DNL in CAD patients. Further large-scale studies are required to conclusively determine the long-term benefits and potential risks associated with each type of drug-coated balloons angioplasty.