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

• Published in: JAMA : the journal of the American Medical Association 2024-03, Vol.331 (12), p.1015-1024
• Main 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
• Format: Article
• Language: English
• Subjects: Angioplasty; Balloon treatment; Blood vessels; Clinical trials; Coatings; Coronary circulation; Diameters; Heart attacks; Heart rate; Implants; Ischemia; Lesions; Medical equipment; Myocardial infarction; Online First; Original Investigation; Paclitaxel; Patients; Restenosis; Stents
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.2024.1361

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 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