Background: There is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories. 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.
|Number of pages||13|
|Journal||JACC: Cardiovascular Interventions|
|State||Published - Oct 10 2022|
Bibliographical noteFunding Information:
This research was supported by an investigator-initiated grant from AstraZeneca. Dr Baber has received honoraria from AstraZeneca and Boston Scientific. Dr Cohen has received grant support, paid to his institution, and consulting fees from AstraZeneca, Medtronic, and Abbott Vascular; and has received grant support, paid to his institution, from Boston Scientific. Dr Angiolillo has received consulting fees or honoraria from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has received payments for participation in review activities from CeloNova and St. Jude Medical, outside the present work; and has received research grants to the institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry, Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr Dangas has received consulting fees and advisory board fees from AstraZeneca; has received consulting fees from Biosensors; and previously held stock in Medtronic. Dr Escaned has received consulting and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic; and has received lecture fees from Abiomed, Terumo, and Biosensors. Dr Gurbel has received grant support and consulting fees from Bayer, Medicure, US WorldMeds, and Merck; has received grant support from Instrumentation Laboratory, Haemonetics, Amgen, Idorsia, Janssen, and Ionis; and holds patent 9188597 on detection of restenosis risk in patients receiving stents by measuring the characteristics of blood clotting, including measurement of maximum thrombin-induced clot strength. Dr Hamm has received lecture and advisory board fees from AstraZeneca. Dr Huber has received lecture fees from AstraZeneca and Bayer. Dr Mehta has received grant support from and has served on an executive committee and as site investigator for AstraZeneca. Dr Ohman has received consulting fees from 3D Communications, ACI Clinical, Biotie, Cara Therapeutics, Cardinal Health, Faculty Connection, Imbria, Impulse Medical, Janssen Pharmaceuticals, Medscape, Milestone Pharmaceuticals, and XyloCor; has received grant support and consulting fees from Abiomed; and has received grant support from Chiesi and Portola. Dr Oldroyd has received grant support and lecture fees from AstraZeneca. Dr Steg has received grant support and fees for serving on a steering committee from Bayer/Janssen; has received grant support and lecture fees from Merck; has received grant support, fees for serving as co-chair of trials, consulting fees, and lecture fees from Sanofi; has received grant support, fees for serving on an executive steering committee, and consulting fees from Amarin; has received consulting and lecture fees from Amgen; has received consulting fees, lecture fees, and fees for serving on a critical event committee from Bristol Myers Squibb; has received fees for serving on an executive steering committee from Boehringer Ingelheim; has received fees for serving on a critical event committee from Pfizer; has received fees for serving on a steering committee and consulting fees from Novartis; has received consulting fees from Regeneron, Eli Lilly, and Novo Nordisk; has received consulting and lecture fees from AstraZeneca; has received grant support, fees for serving as chair of a data monitoring committee, and fees for serving as chair of a registry from Servier; and has received fees for serving on a steering committee from Idorsia. Dr. Gibson has received grant support and consulting fees from Angel Medical, Bayer, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson, and Portola Pharmaceuticals; has received consulting fees from The Medicines Company, Eli Lilly, Gilead Sciences, Novo Nordisk, WebMD, UpToDate Cardiovascular Medicine, Amarin Pharma, Amgen, Boehringer Ingelheim, Chiesi, Merck, PharmaMar, Sanofi, Somahlution, Verreseon, Boston Scientific, Impact Bio, MedImmume, Medtelligence, MicroPort, the PERT Consortium, and GE Healthcare; holds equity in Inference; serves as chief executive officer of the Baim Institute; and has received grant support, paid to the Baim Institute, from Bristol Myers Squibb and Astra Zeneca. Dr Mehran has received institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, Daiichi Sankyo, Insel Gruppe, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, and Zoll; has received personal fees from the American College of Cardiology, Boston Scientific, the California Institute for Regenerative Medicine, Cine-Med Research, Janssen, WebMD, and the Society for Cardiovascular Angiography and Interventions; has received consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, Daiichi Sankyo, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Philips; holds equity (<1%) in Applied Therapeutics, Elixir Medical, STEL, and CONTROLRAD (spouse); and is a scientific advisory board member for the American Medical Association and Biosensors (spouse). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
© 2022 American College of Cardiology Foundation
- body mass index
- coronary artery disease
- dual antiplatelet therapy
- percutaneous coronary intervention
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine