Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial.

Key Points: Question: Is treatment with a coronary paclitaxel-coated balloon superior to an uncoated balloon for 1-year target lesion failure in patients undergoing percutaneous coronary intervention for in-stent restenosis? Findings: In a multicenter randomized trial of 600 patients designed to support US regulatory approval, target lesion failure was significantly lower in the paclitaxel-coated balloon group (17.9%) compared with the uncoated balloon group (28.6%) (P =.003). Ischemia-driven target lesion revascularization and target vessel myocardial infarction were also lower after treatment with a paclitaxel-coated balloon. Meaning: Treatment with a paclitaxel-coated balloon offers an effective treatment strategy for the management of coronary in-stent restenosis. Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure—defined as the composite of ischemia-driven target lesion revascularization, target vessel–related myocardial infarction, or cardiac death—was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P =.003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P =.001) and target vessel–related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P =.02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P =.38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253 This clinical trial compares a paclitaxel-coated balloon vs an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]