Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis
Authors: Yeh Robert W. , Shlofmitz Richard , Moses Jeffrey , Bachinsky William , Dohad Suhail , Rudick Steven , Stoler Robert , Jefferson Brian K. , Nicholson William , Altman John , Bateman Cinthia , Krishnaswamy Amar , Grantham J. Aaron , Zidar Frank J. , Marso Steven P. , Tremmel Jennifer A. , Grines Cindy , Ahmed Mustafa I. , Latib Azeem , Tehrani Behnam , Abbott J. Dawn , Batchelor Wayne , Underwood Paul , Allocco Dominic J. , Kirtane Ajay J. ,   AGENT IDE Investigators, Shlofmitz Richard , Moses Jeffrey , Bachinsky William , Dohad Suhail , Rudick Steven , Stoler Robert , Jefferson Brian , Nicholson William , Altman John , Yeh Robert , Bateman Cinthia Tjan , Krishnaswamy Amar , Grantham J. Aaron , Zidar Francis , Sabapathy Rajendran , Tremmel Jennifer , Grines Cindy , Ahmed Mustafa , Latib Azeem , Tehrani Behnam , Alaswad Khaldoon , Kimmelstiel Carey , Dixon William , Reitman Arthur , Ang Lawrence , Levisay Justin , Abbott Jinnette , Kearney Kathleen , Jaffer Farouc , Neupane Saroj , Croce Kevin , Shunk Kendrick , Taylor Angela , Saybolt Matthew , Diaz Claro , Shah Alpesh , Lotun Kapil , Brechtken Johannes , Agarwal Himanshu , Patel Rajan 
Published: March 2024

ImportanceDrug-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.ObjectiveTo 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 ParticipantsAGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length &amp;lt;26 mm and reference vessel diameter &amp;gt;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.InterventionsParticipants 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 MeasuresThe 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.ResultsAmong 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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT04647253