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