Ticagrelor vs Prasugrel in Patients With Diabetes and Multivessel Coronary Artery Disease: The TUXEDO-2 Randomized Clinical Trial.
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Bangalore Sripal, Sinha Santosh Kumar, Singh Rakendra, Parida Ashok Kumar, Mody Rohit, Abhaichand Rajpal, Banker Darshan, Khan Aziz, Kalyansundaram Arun, Moorthy Nagaraja, Mahajan Kunal, Mohan Bishav, Meel Bhaveesh, Singh Rajpal, Porwal Sanjay, Bhagwat Ajit, Bahuleyan Charantharayail Gopalan, Davidson Deepak, Koganti Sudheer, Garsa Sunil Kumar, Kerkar Prafulla, Koduru Gopala Krishna, Sreedharan Madhu, Jagtap Prashant, Manohar G, Kumar Santosh, Arambam Priyadarshini, Khan Nagma, Koul Varsha, Sudhir Krishnankutty, Kaul Upendra, TUXEDO-2 India Investigators
Аннотация
OBJECTIVE: To compare the clinical outcomes of ticagrelor vs prasugrel, each in combination with aspirin, in patients with diabetes and multivessel coronary artery disease who underwent percutaneous coronary intervention.
DESIGN, SETTING, AND PARTICIPANTS: The Ultrathin Strut vs Xience in a Diabetic Population With Multivessel Disease 2-India Study (TUXEDO-2) is an investigator-initiated, prospective, open-label, multicenter, 2 × 2 factorial design, 1:1 randomized clinical trial. Participants with diabetes and multivessel disease undergoing percutaneous coronary intervention were enrolled at 66 clinical sites from February 2020 to August 2024.
INTERVENTIONS: Patients undergoing percutaneous coronary intervention were randomized to receive either ticagrelor or prasugrel, each in combination with low-dose aspirin.
MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of death, nonfatal myocardial infarction, stroke, or major bleeding as defined by the Bleeding Academic Research Consortium at 1 year. The trial was designed to test the noninferiority of ticagrelor compared with prasugrel with a noninferiority margin of 5%.
RESULTS: Among the 1800 participants randomized, mean (SD) age was 60 (10) years with 1296 (72.0%) male participants, 436 (24.2%) receiving insulin therapy, and 1530 (85.0%) with triple-vessel disease. At 1 year, the primary end point occurred in 129 participants (16.6%) taking ticagrelor and 107 participants (14.2%) taking prasugrel (P = .12). The risk difference of 2.33 percentage points (95% CI, -2.07 to 6.74 percentage points) failed to meet the prespecified threshold for noninferiority (P = .84). There was numerically higher (but not statistically significant) composite of death, myocardial infarction, stroke (10.43% vs 8.63%; P = .30), and major bleeding (8.41% vs 7.14%; P = .19) with ticagrelor when compared with prasugrel.
CONCLUSIONS AND RELEVANCE: In patients with diabetes and multivessel disease undergoing PCI, ticagrelor was not noninferior to prasugrel for the reduction of primary outcome at 1 year of follow-up.
TRIAL REGISTRATION: CTRI/2019/11/022088.