Usman Baber1,2, George Dangas2, Dominick Joseph Angiolillo3, David Joel Cohen4, Samin Kumar Sharma2, Johny Nicolas2, Carlo Briguori5, Jin Yu Cha2, Timothy Collier6, Dariusz Dudek7, Vladimir Džavik8, Javier Escaned9, Robert Gil10, Paul Gurbel11, Christian W Hamm12, Timothy Henry13, Kurt Huber14, Adnan Kastrati15, Upendra Kaul16, Ran Kornowski17, Mitchell Krucoff18, Vijay Kunadian19,20, Steven Owen Marx21, Shamir Mehta22, David Moliterno23, Erik Magnus Ohman18, Keith Oldroyd24, Gennaro Sardella25, Samantha Sartori2, Richard Shlofmitz26, Philippe Gabriel Steg27, Giora Weisz28, Bernhard Witzenbichler29, Ya-Ling Han30, Stuart Pocock6, Charles Michael Gibson31, Roxana Mehran2. 1. Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA. 2. Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA. 3. Department of Cardiology, University of Florida-Shands, Jacksonville, FL 32218, USA. 4. Department of Cardiology, University of Missouri-Kansas CIty, Kansas City, MO 64110, USA. 5. Department of Cardiology, Clinica Mediterranea, 80122 Napoli NA, Italy. 6. Department of Cardiology, London School of Hygiene and Tropical Medicine, Keppel St, Bloomsbury, London WC1E 7HT, UK. 7. The 2nd Department of Cardiology Jagiellonian University Medical College, Swietej Anny 12, 31-008 Krakow, Poland. 8. Department of Interventional Cardiology, Research and Innovation in Interventional Cardiology and Cardiac Intensive Care, Peter Munk Cardiac Centre, University Health Network, 200 Elizabeth St, Toronto, ON M5G 2CA, Canada. 9. Department of Cardiology, Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos and Complutense University, Calle del Prof Martin Lagos, s/n, 28040 Madrid, Spain. 10. Department of Invasive Cardiology, Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, 137 Woloska Str, 02-507 Warsaw, Poland. 11. Department of Cardiology, Sinai Hospital of Baltimore System, Baltimore, MD 21215, USA. 12. Department of Cardiology, Kerckhoff Clinic, Benekestrabe 2-8, 61231 Bad Nauheim, Germany. 13. Department of Cardiology, The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital, Cincinnati, OH 45219, USA. 14. Department of Cardiology, Wilhelminenhospital, Montleartstrabe 37, 1160 Wien, Austria. 15. Department of Cardiology, Deutsches Herzzentrum Munchen, Lazarettstrabe 36, 80636 Munchen, Germany. 16. Department of Cardiology, Batra Hospital and Medical Research Centre, New Delhi 110062, India. 17. Department of Cardiology, Rabin Medical Center, Zeev Jabutinsky Rd 39, Petach Tikva 49100, Israel. 18. Department of Cardiology, Duke University Medical Center-Duke Clinical Research Institute, Durham, NC 27710, USA. 19. Department of Cardiology, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Freeman Road, High Heaton, NE7 7DN Newcastle upon Tyne, UK. 20. Department of Cardiology, Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Road, High Heaton, NE7 7DN Newcastle upon Tyne, UK. 21. Department of Cardiology, Columbia University Medical Center, New York, NY 10027, USA. 22. Department of Cardiology, Hamilton Health Sciences, Hamilton, ON L8N 3Z5, Canada. 23. Department of Cardiology, University of Kentucky, Lexington, KY 40506, USA. 24. Department of Cardiology, The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Agamemnon St, Clydebank G81 4DY, UK. 25. Department of Cardiology, Policlinico Umberto I University, 00161 Roma, Italy. 26. Department of Cardiology, St. Francis Hospital, Roslyn, 100 Port Washington Blvd, Roslyn, NY 11576, USA. 27. Department of Cardiology, Groupe Hospitalier Bichat-Claude-Bernard, 46 Rue Henri Huchard, 75018 Paris, France. 28. Department of Cardiology, Montefiore Medical Center, The Bronx, NY 10467, USA. 29. Department of Cardiology, Helios Amper-Klinikum, Krankenhausstrabe 15, 85221 Dachau, Germany. 30. Department of Cardiology, Shenyang North Hospital, Huanggu Qu, Shenyang Shi, Liaoning Sheng, China. 31. Department of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.
Abstract
AIMS: The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS AND RESULTS: We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96). CONCLUSION: Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02270242. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS AND RESULTS: We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96). CONCLUSION: Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02270242. Published on behalf of the European Society of Cardiology. All rights reserved.
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