作者
Robert W. Yeh,Richard Shlofmitz,Jeffrey W. Moses,William Bachinsky,Suhail Dohad,Steven Rudick,Robert C. Stoler,Brian Jefferson,William Nicholson,John D. Altman,Cinthia Bateman,Amar Krishnaswamy,J. Aaron Grantham,Frank J. Zidar,Steven P. Marso,Jennifer A. Tremmel,Cindy L. Grines,Mustafa I. Ahmed,Azeem Latib,Behnam Tehrani,J. Dawn Abbott,Wayne Batchelor,Paul Underwood,Dominic J. Allocco,Ajay J. Kirtane,Richard Shlofmitz,Jeffrey Moses,William Bachinsky,Suhail Dohad,Steven Rudick,Robert C. Stoler,Brian Jefferson,William Nicholson,John D. Altman,Robert W. Yeh,Cinthia Bateman,Amar Krishnaswamy,J. Aaron Grantham,Frank J. Zidar,Rajendran Sabapathy,Jennifer A. Tremmel,Cindy L. Grines,Mustafa I. Ahmed,Azeem Latib,Behnam Tehrani,Khaldoon Alaswad,Carey Kimmelstiel,William Dixon,Arthur Reitman,Lawrence Ang,Justin Levisay,J. Dawn Abbott,Kathleen E. Kearney,Farouc A. Jaffer,Saroj Neupane,Kevin Croce,Kendrick A. Shunk,Angela M. Taylor,Matthew D. Saybolt,Claro Diaz,Alpesh Shah,Kapil Lotun,Johannes Brechtken,Himanshu Agarwal,Rajan Patel
摘要
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.To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention.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.Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon.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.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.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.ClinicalTrials.gov Identifier: NCT04647253.