George Dangas1, Usman Baber1, Samin Sharma1, Gennaro Giustino1, Shamir Mehta2, David J Cohen3, Dominick J Angiolillo4, Samantha Sartori1, Rishi Chandiramani1, Carlo Briguori5, Dariusz Dudek6, Javier Escaned7, Kurt Huber8, Timothy Collier9, Ran Kornowski10, Vijay Kunadian11, Upendra Kaul12, Keith Oldroyd13, Gennaro Sardella14, Richard Shlofmitz15, Bernhard Witzenbichler16, Han Ya-Ling17, Stuart Pocock9, C Michael Gibson18, Roxana Mehran19. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. 3. University of Missouri-Kansas City, Kansas City, Missouri. 4. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida. 5. Mediterranea Cardiocentro, Naples, Italy. 6. Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland; Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy. 7. Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain. 8. 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria. 9. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom. 10. Cardiology Department, Rabin Medical Center, Petach Tikva, Israel. 11. 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. 12. Batra Hospital and Medical Research Center, New Delhi, India. 13. West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom. 14. Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy. 15. St. Francis Hospital, Roslyn, New York. 16. Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany. 17. Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China. 18. Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. 19. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.
Abstract
BACKGROUND: Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown. OBJECTIVES: The purpose of this study was to evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. METHODS: In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization. RESULTS: Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38 to 0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21 to 0.80). There were no significant between-group differences in death, myocardial infarction, or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52 to 1.15), nor in stent thrombosis. CONCLUSIONS: Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
RCT Entities:
BACKGROUND: Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown. OBJECTIVES: The purpose of this study was to evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. METHODS: In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization. RESULTS: Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38 to 0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21 to 0.80). There were no significant between-group differences in death, myocardial infarction, or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52 to 1.15), nor in stent thrombosis. CONCLUSIONS: Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
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