Bleeding and Ischemic Outcomes With Ticagrelor Monotherapy According to Body Mass Index |
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| Institution: | 1. Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom;2. Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA;3. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA;4. IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy;5. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy;6. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA;7. Mediterranea Cardiocentro, Naples, Italy;8. Cardiovascular Research Foundation, New York, New York, USA;9. St. Francis Hospital, Roslyn, Roslyn, New York, USA;10. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom;11. Jagiellonian University Medical College, Krakow, Poland;12. Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA;13. Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland;14. 3rd Department Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria;15. Batra Hospital and Medical Research Centre, New Delhi, India;p. Rabin Medical Center, Petach Tikva, Israel;q. Duke University Medical Center–Duke Clinical Research Institute, Durham, North Carolina, USA;r. Prairie Vascular Research, Regina, Saskatchewan, Canada;s. Hamilton Health Sciences, Hamilton, Ontario, Canada;t. University of Kentucky, Lexington, Kentucky, USA;u. Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain;v. Policlinico Umberto I University, Rome, Italy;w. NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA;x. Helios Amper-Klinikum, Dachau, Germany;y. Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada;z. Sinai Hospital of Baltimore System, Baltimore, Maryland, USA;11. Kerckhoff Clinic, Bad Nauheim, Germany;22. The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital, Cincinnati, Ohio, USA;33. Deutsches Herzzentrum München, Munich, Germany;44. Columbia University Medical Center, New York, New York, USA;55. The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom;66. Université de Paris and Assistance Publique-Hôpitaux de Paris, Paris, France |
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| Abstract: | BackgroundThere is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories.ObjectivesThe 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.MethodsThe 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.ResultsAmong 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.ConclusionsAmong 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. |
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| Keywords: | aspirin body mass index coronary artery disease dual antiplatelet therapy percutaneous coronary intervention ticagrelor BARC"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"Bleeding Academic Research Consortium BMI"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"body mass index DAPT"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"dual antiplatelet therapy ESC"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"European Society of Cardiology ISTH"} {"#name":"keyword" "$":{"id":"kwrd0085"} "$$":[{"#name":"text" "_":"International Society on Thrombosis and Hemostasis MI"} {"#name":"keyword" "$":{"id":"kwrd0095"} "$$":[{"#name":"text" "_":"myocardial infarction NACE"} {"#name":"keyword" "$":{"id":"kwrd0105"} "$$":[{"#name":"text" "_":"net adverse clinical event(s) PCI"} {"#name":"keyword" "$":{"id":"kwrd0115"} "$$":[{"#name":"text" "_":"percutaneous coronary intervention |
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