| Institution: | 1. University of Florida College of Medicine, Jacksonville, Florida, USA;2. The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA;3. The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA;4. Hamilton Health Sciences, Hamilton, Ontario, Canada;5. Mediterranea Cardiocentro, Naples, Italy;6. University of Missouri–Kansas City, Kansas City, Missouri, USA;7. London School of Hygiene and Tropical Medicine, London, United Kingdom;8. Jagiellonian University Medical College, Krakow, Poland;9. Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos and Complutense University, Madrid, Spain;10. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA;11. Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland;12. Wilhelminenspital, Wien, Austria;13. Batra Hospital and Medical Research Centre, New Delhi, India;14. Rabin Medical Center, Petach Tikva, Israel;15. Duke University Medical Center–Duke Clinical Research Institute, Durham, North Carolina, USA;p. 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;q. University of Kentucky, Lexington, Kentucky, USA;r. The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom;s. Policlinico Umberto I University, Rome, Italy;t. St. Francis Hospital, Roslyn, Roslyn, New York, USA;u. NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, USA;v. Helios Amper-Klinikum, Dachau, Germany |
| Abstract: | ObjectivesThe aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI).BackgroundAs the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age.MethodsThe TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke.ResultsA total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (pinteraction = 0.62) and key secondary (pinteraction = 0.77) endpoints and across different age categories.ConclusionsA strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age. |
