Marco Valgimigli1, Roxana Mehran2, Anna Franzone3, Bruno R da Costa4, Usman Baber2, Raffaele Piccolo3, Eùgene P McFadden5, Pascal Vranckx6, Dominick J Angiolillo7, Sergio Leonardi8, Davide Cao2, George D Dangas2, Shamir R Mehta9, Patrick W Serruys10, C Michael Gibson11, Gabriel P Steg12, Samin K Sharma2, Christian Hamm13, Richard Shlofmitz14, Christoph Liebetrau13, Carlo Briguori15, Luc Janssens16, Kurt Huber17, Maurizio Ferrario7, Vijay Kunadian18, David J Cohen19, Aleksander Zurakowski20, Keith G Oldroyd21, Han Yaling22, Dariuz Dudek23, Samantha Sartori2, Brian Kirkham4, Javier Escaned24, Dik Heg25, Stephan Windecker26, Stuart Pocock27, Peter Jüni4. 1. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland. Electronic address: marco.valgimigli@insel.ch. 2. Icahn School of Medicine at Mount Sinai, New York, New York, USA. 3. Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy. 4. Applied Health Research Centre of the Li Ka Shing Knowledge Institute, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 5. Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; Department of Cardiology, Cork University Hospital, Cork, Ireland. 6. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium. 7. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA. 8. University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy. 9. McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. 10. International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College, London, United Kingdom. 11. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. 12. Université de Paris and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France. 13. German Center for Cardiovascular Research, partner site RheinMain, Frankfurt am Main, Germany; Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. 14. Department of Cardiology, St. Francis Hospital, Roslyn, New York, USA. 15. Clinica Mediterranea, Naples, Italy. 16. Imelda Hospital, Bonheiden, Belgium. 17. 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University Medical School, Vienna, Austria. 18. Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom. 19. Cardiovascular Research, Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA. 20. Department of Interventional Cardiology Chrzanów, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland. 21. The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom. 22. General Hospital of Northern Theater Command, Shenyang, Liaoning, China. 23. Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland; Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy. 24. Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos and Complutense University, Madrid, Spain. 25. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom. 26. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. 27. London School of Hygiene and Tropical Medicine, London, United Kingdom.
Abstract
OBJECTIVES: The aim of this study was to compare ticagrelor monotherapy with dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents. BACKGROUND: The role of abbreviated DAPT followed by an oral P2Y12 inhibitor after PCI remains uncertain. METHODS: Two randomized trials, including 14,628 patients undergoing PCI, comparing ticagrelor monotherapy with standard DAPT on centrally adjudicated endpoints were identified, and individual patient data were analyzed using 1-step fixed-effect models. The protocol was registered in PROSPERO (CRD42019143120). The primary outcomes were the composite of Bleeding Academic Research Consortium type 3 or 5 bleeding tested for superiority and, if met, the composite of all-cause death, myocardial infarction, or stroke at 1 year, tested for noninferiority against a margin of 1.25 on a hazard ratio (HR) scale. RESULTS: Bleeding Academic Research Consortium type 3 or 5 bleeding occurred in fewer patients with ticagrelor than DAPT (0.9% vs. 1.7%, respectively; HR: 0.56; 95% confidence interval [CI]: 0.41 to 0.75; p < 0.001). The composite of all-cause death, myocardial infarction, or stroke occurred in 231 patients (3.2%) with ticagrelor and in 254 patients (3.5%) with DAPT (HR: 0.92; 95% CI: 0.76 to 1.10; p < 0.001 for noninferiority). Ticagrelor was associated with lower risk for all-cause (HR: 0.71; 95% CI: 0.52 to 0.96; p = 0.027) and cardiovascular (HR: 0.68; 95% CI: 0.47 to 0.99; p = 0.044) mortality. Rates of myocardial infarction (2.01% vs. 2.05%; p = 0.88), stent thrombosis (0.29% vs. 0.38%; p = 0.32), and stroke (0.47% vs. 0.36%; p = 0.30) were similar. CONCLUSIONS: Ticagrelor monotherapy was associated with a lower risk for major bleeding compared with standard DAPT, without a concomitant increase in ischemic events.
OBJECTIVES: The aim of this study was to compare ticagrelor monotherapy with dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents. BACKGROUND: The role of abbreviated DAPT followed by an oral P2Y12 inhibitor after PCI remains uncertain. METHODS: Two randomized trials, including 14,628 patients undergoing PCI, comparing ticagrelor monotherapy with standard DAPT on centrally adjudicated endpoints were identified, and individual patient data were analyzed using 1-step fixed-effect models. The protocol was registered in PROSPERO (CRD42019143120). The primary outcomes were the composite of Bleeding Academic Research Consortium type 3 or 5 bleeding tested for superiority and, if met, the composite of all-cause death, myocardial infarction, or stroke at 1 year, tested for noninferiority against a margin of 1.25 on a hazard ratio (HR) scale. RESULTS:Bleeding Academic Research Consortium type 3 or 5 bleeding occurred in fewer patients with ticagrelor than DAPT (0.9% vs. 1.7%, respectively; HR: 0.56; 95% confidence interval [CI]: 0.41 to 0.75; p < 0.001). The composite of all-cause death, myocardial infarction, or stroke occurred in 231 patients (3.2%) with ticagrelor and in 254 patients (3.5%) with DAPT (HR: 0.92; 95% CI: 0.76 to 1.10; p < 0.001 for noninferiority). Ticagrelor was associated with lower risk for all-cause (HR: 0.71; 95% CI: 0.52 to 0.96; p = 0.027) and cardiovascular (HR: 0.68; 95% CI: 0.47 to 0.99; p = 0.044) mortality. Rates of myocardial infarction (2.01% vs. 2.05%; p = 0.88), stent thrombosis (0.29% vs. 0.38%; p = 0.32), and stroke (0.47% vs. 0.36%; p = 0.30) were similar. CONCLUSIONS:Ticagrelor monotherapy was associated with a lower risk for major bleeding compared with standard DAPT, without a concomitant increase in ischemic events.
Authors: Davide Capodanno; Deepak L Bhatt; C Michael Gibson; Stefan James; Takeshi Kimura; Roxana Mehran; Sunil V Rao; Philippe Gabriel Steg; Philip Urban; Marco Valgimigli; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2021-08-23 Impact factor: 32.419