TCT-501 Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Coronary In-Stent Restenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Document Type

Conference Proceeding

Publication Date

10-29-2024

Publication Title

J Am Coll Cardiol

Abstract

Background: 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). Methods: We searched PubMed/MEDLINE, Cochrane Library, and ClinicalTrials.gov for RCTs evaluating PCBs vs uncoated/plain old balloon angioplasty (POBA) in patients with coronary ISR. The outcomes of interest were target lesion revascularization (TLR), major adverse cardiovascular events (MACE), all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and stent thrombosis. We pooled the estimates using inverse variance random-effects model. The effect sizes were reported as risk ratio (RR) with 95% CI. Results: A total of 6 RCTs with 1,343 patients were included. At a follow-up ranging from 6-12 months from randomization, 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) when compared with POBA for coronary ISR. However, there was no significant difference in risk between PCBs and POBA 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). [Formula presented] Conclusion: This meta-analysis suggests that PCBs compared with POBA for treatment of coronary ISR was associated with significant decrease in TLR, and MACE without any significant difference in mortality, MI, or stent thrombosis. Categories: CORONARY: Drug-Eluting Balloons and Local Drug Delivery.

Volume

84

Issue

18

First Page

B166

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