Bleeding and Ischemic Outcomes With Ticagrelor Monotherapy According to Body Mass Index.
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Kunadian Vijay, Baber Usman, Pivato Carlo A, Cao Davide, Dangas George, Sartori Samantha, Zhang Zhongjie, Angiolillo Dominick J, Briguori Carlo, Cohen David J, Collier Timothy, Dudek Dariusz, Gibson Michael, Gil Robert, Huber Kurt, Kaul Upendra, Kornowski Ran, Krucoff Mitchell W, Dehghani Payam, Mehta Shamir, Moliterno David J, Ohman E Magnus, Escaned Javier, Sardella Gennaro, Sharma Samin K, Shlofmitz Richard, Weisz Giora, Witzenbichler Bernhard, Džavík Vladimír, Gurbel Paul, Hamm Christian W, Henry Timothy, Kastrati Adnan, Marx Steven O, Oldroyd Keith, Steg P Gabriel, Pocock Stuart, Mehran Roxana
Аннотация
OBJECTIVES: The aim of this study was to investigate bleeding and ischemic outcomes according to BMI in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial.
METHODS: The TWILIGHT trial randomized high-risk patients to ticagrelor plus aspirin or ticagrelor plus placebo at 3 months after percutaneous coronary intervention. In this secondary analysis, patients were stratified by standard BMI categories, as recommended by the European Society of Cardiology Working Group on Thrombosis (normal weight [BMI 18.5-24.99 kg/m2], overweight [BMI 25-29.99 kg/m2], and obese [BMI ≥30 kg/m2]) and by median BMI, as prespecified in the protocol.
RESULTS: Among 7,038 patients randomized and with available BMI, 1,807 (25.7%) were normal weight, 2,927 (41.6%) were overweight, and 2,304 (32.7%) were obese. In normal-weight, overweight, and obese patients, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced the primary endpoint of Bleeding Academic Research Consortium type 2, 3, or 5 bleeding (normal weight: HR: 0.48 [95% CI: 0.32-0.73]; overweight: HR: 0.57 [95% CI: 0.41-0.78]; obese: HR: 0.63 [95% CI: 0.44-0.91]; P for interaction = 0.627), without any increase in the composite ischemic endpoint of all-cause death, myocardial infarction, or stroke (normal weight: HR: 1.36 [95% CI: 0.84-2.19]; overweight: HR: 0.92 [95% CI: 0.63-1.35]; obese: HR: 0.84 [95% CI: 0.56-1.25]; P for interaction = 0.290). These findings were consistent with the prespecified analysis by median BMI.
CONCLUSIONS: Among high-risk patients undergoing percutaneous coronary intervention, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced bleeding events without any increase in ischemic risk across different BMI categories.