• Robert W Yeh, Richard Shlofmitz, Jeffrey Moses, William Bachinsky, Suhail Dohad, Steven Rudick, Robert Stoler, Brian K Jefferson, William Nicholson, John Altman, Cinthia Bateman, Amar Krishnaswamy, J Aaron Grantham, Frank J Zidar, Steven P Marso, Jennifer A Tremmel, Cindy Grines, Mustafa I Ahmed, Azeem Latib, Behnam Tehrani, J Dawn Abbott, Wayne Batchelor, Paul Underwood, Dominic J Allocco, Ajay J Kirtane, and AGENT IDE Investigators.
• Beth Israel Deaconess Medical Center, Boston, Massachusetts.
• JAMA. 2024 Mar 26; 331 (12): 101510241015-1024.

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 <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.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.

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