Mauro Chiarito1, Usman Baber2, Davide Cao3, Samin K Sharma3, George Dangas3, Dominick J Angiolillo4, Carlo Briguori5, David J Cohen6, Dariusz Dudek7, Vladimír Džavík8, Javier Escaned9, Robert Gil10, Christian W Hamm11, Timothy Henry12, Kurt Huber13, Adnan Kastrati14, Upendra Kaul15, Ran Kornowski16, Mitchell Krucoff17, Vijay Kunadian18, Shamir R Mehta19, David Moliterno20, E Magnus Ohman17, Keith Oldroyd21, Gennaro Sardella22, Zhang Zhongjie3, Samantha Sartori3, Giulio Stefanini23, Richard Shlofmitz24, P Gabriel Steg25, Giora Weisz26, Bernhard Witzenbichler27, Ya-Ling Han28, Stuart Pocock29, C Michael Gibson30, Roxana Mehran31. 1. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy; Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy. 2. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA. 3. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. 4. University of Florida College of Medicine, Jacksonville, Florida, USA. 5. Clinica Mediterranea, Naples, Italy. 6. Cardiovascular Research Foundation, New York, New York, USA; St. Francis Hospital, Roslyn, New York, USA. 7. 2nd Department of Cardiology Jagiellonian University Medical College, Krakow, Poland. 8. Research and Innovation in Interventional Cardiology and Cardiac Intensive Care, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada. 9. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos and Complutense University, Madrid, Spain. 10. Department of Invasive Cardiology, Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland. 11. Kerckhoff Clinic, Bad Nauheim, Germany. 12. Carl and Edyth Lindner Center for Research and Education at the Christ Hospital, Cincinnati, Ohio, USA. 13. Wilhelminenhospital, Vienna, Austria. 14. Deutsches Herzzentrum München, Munich, Germany. 15. Batra Hospital and Medical Research Centre, New Delhi, India. 16. Rabin Medical Center, Petach Tikva, Israel. 17. Duke University Medical Center-Duke Clinical Research Institute, Durham, North Carolina, USA. 18. Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom. 19. Hamilton Health Sciences, Hamilton, Ontario, Canada. 20. University of Kentucky, Lexington, Kentucky, USA. 21. West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom. 22. Policlinico Umberto I University, Rome, Italy. 23. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy; Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy. 24. St. Francis Hospital, Roslyn, New York, USA. 25. Groupe Hospitalier Bichat-Claude-Bernard, Paris, France. 26. Montefiore Medical Center, New York, New York, USA. 27. Helios Amper-Klinikum, Dachau, Germany. 28. Shenyang North Hospital, Shenyang, China. 29. London School of Hygiene and Tropical Medicine, London, United Kingdom. 30. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. 31. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: roxana.mehran@mountsinai.org.
Abstract
OBJECTIVES: The aim of this study was to evaluate if patients with prior myocardial infarction (MI) could benefit from ticagrelor monotherapy in terms of bleeding reduction without any compromise in ischemic event prevention. BACKGROUND: Patients with history of MI who undergo percutaneous coronary intervention (PCI) remain at risk for recurrent ischemic events. The optimal antithrombotic strategy for this cohort remains debated. METHODS: In this prespecified analysis of the randomized TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, the authors evaluated the impact of history of MI on treatment effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing PCI with drug-eluting stent with at least 1 clinical and 1 angiographic high-risk feature and free from adverse events at 3 months after index PCI. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, and the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12 months after randomization. RESULTS: A total of 1,937 patients (29.7%) with and 4,595 patients (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. At 1 year after randomization, patients with prior MI experienced higher rates of death, MI, or stroke (5.7% vs 3.2%; P < 0.001) but similar BARC types 2 to 5 bleeding (5.0% vs 5.5%; P = 0.677) compared with patients without prior MI. Ticagrelor monotherapy consistently reduced the risk for the primary bleeding outcome in patients with (3.4% vs 6.7%; HR: 0.50; 95% CI: 0.33-0.76) and without (4.2% vs 7.0%; HR: 0.58; 95% CI: 0.45-0.76; Pinteraction = 0.54) prior MI. Rates of the key secondary ischemic outcome were not significantly different between treatment groups irrespective of history of MI (prior MI, 6.0% vs 5.5% [HR: 1.09; 95% CI: 0.75-1.58]; no prior MI, 3.1% vs 3.3% [HR: 0.92; 95% CI: 0.67-1.28]; Pinteraction = 0.52). CONCLUSIONS: Ticagrelor monotherapy is associated with significantly lower risk for bleeding events compared with ticagrelor plus aspirin, without any compromise in ischemic prevention, among high-risk patients with history of MI undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
OBJECTIVES: The aim of this study was to evaluate if patients with prior myocardial infarction (MI) could benefit from ticagrelor monotherapy in terms of bleeding reduction without any compromise in ischemic event prevention. BACKGROUND: Patients with history of MI who undergo percutaneous coronary intervention (PCI) remain at risk for recurrent ischemic events. The optimal antithrombotic strategy for this cohort remains debated. METHODS: In this prespecified analysis of the randomized TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, the authors evaluated the impact of history of MI on treatment effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing PCI with drug-eluting stent with at least 1 clinical and 1 angiographic high-risk feature and free from adverse events at 3 months after index PCI. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, and the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12 months after randomization. RESULTS: A total of 1,937 patients (29.7%) with and 4,595 patients (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. At 1 year after randomization, patients with prior MI experienced higher rates of death, MI, or stroke (5.7% vs 3.2%; P < 0.001) but similar BARC types 2 to 5 bleeding (5.0% vs 5.5%; P = 0.677) compared with patients without prior MI. Ticagrelor monotherapy consistently reduced the risk for the primary bleeding outcome in patients with (3.4% vs 6.7%; HR: 0.50; 95% CI: 0.33-0.76) and without (4.2% vs 7.0%; HR: 0.58; 95% CI: 0.45-0.76; Pinteraction = 0.54) prior MI. Rates of the key secondary ischemic outcome were not significantly different between treatment groups irrespective of history of MI (prior MI, 6.0% vs 5.5% [HR: 1.09; 95% CI: 0.75-1.58]; no prior MI, 3.1% vs 3.3% [HR: 0.92; 95% CI: 0.67-1.28]; Pinteraction = 0.52). CONCLUSIONS: Ticagrelor monotherapy is associated with significantly lower risk for bleeding events compared with ticagrelor plus aspirin, without any compromise in ischemic prevention, among high-risk patients with history of MI undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
Authors: Davide Capodanno; Usman Baber; Deepak L Bhatt; Jean-Philippe Collet; George Dangas; Francesco Franchi; C Michael Gibson; Hyeon-Cheol Gwon; Adnan Kastrati; Takeshi Kimura; Pedro A Lemos; Renato D Lopes; Roxana Mehran; Michelle L O'Donoghue; Sunil V Rao; Fabiana Rollini; Patrick W Serruys; Philippe G Steg; Robert F Storey; Marco Valgimigli; Pascal Vranckx; Hirotoshi Watanabe; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2022-06-13 Impact factor: 32.419