| Institution: | 1. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida;2. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York;3. Mediterranea Cardiocentro, Naples, Italy;4. University of Missouri-Kansas City, Kansas City, Missouri;5. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada;6. Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts;7. 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria;8. Cardiology Department, Rabin Medical Center, Petach Tikva, Israel;9. Department of Cardiology, Montefiore Medical Center, Bronx, New York;10. 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;11. West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom;12. Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China;13. Batra Hospital and Medical Research Center, New Delhi, India;14. Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany;15. Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland;p. Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy;q. Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy;r. Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain;s. St. Francis Hospital, Roslyn, New York;t. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom |
| Abstract: | BackgroundP2Y12 inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown.ObjectivesThe purpose of this study was to examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI.MethodsThis was a pre-specified analysis of the DM cohort in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke.ResultsPatients with DM comprised 37% (n = 2,620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium 2, 3, or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (hazard ratio: 0.65; 95% confidence interval: 0.47 to 0.91; p = 0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs. 5.9%; hazard ratio: 0.77; 95% confidence interval: 0.55 to 1.09; p = 0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints.ConclusionsCompared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention TWILIGHT]; NCT02270242) |
