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
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 <26 mm and reference vessel diameter >2...
March 9, 2024: JAMA