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Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis
Authors:Marco Valgimigli  Roxana Mehran  Anna Franzone  Bruno R. da Costa  Usman Baber  Raffaele Piccolo  Eùgene P. McFadden  Pascal Vranckx  Dominick J. Angiolillo  Sergio Leonardi  Davide Cao  George D. Dangas  Shamir R. Mehta  Patrick W. Serruys  C. Michael Gibson  Gabriel P. Steg  Samin K. Sharma  Christian Hamm  Stephan Windecker
Affiliation:1. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland;2. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland;3. Icahn School of Medicine at Mount Sinai, New York, New York, USA;4. Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy;5. Applied Health Research Centre of the Li Ka Shing Knowledge Institute, Department of Medicine, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada;6. Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands;7. Department of Cardiology, Cork University Hospital, Cork, Ireland;8. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium;9. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA;10. University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy;11. McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada;12. International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College, London, United Kingdom;13. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA;14. Université de Paris and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France;15. German Center for Cardiovascular Research, partner site RheinMain, Frankfurt am Main, Germany;p. Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany;q. Department of Cardiology, St. Francis Hospital, Roslyn, New York, USA;r. Clinica Mediterranea, Naples, Italy;s. Imelda Hospital, Bonheiden, Belgium;t. 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University Medical School, Vienna, Austria;u. 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;v. Cardiovascular Research, Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, USA;w. Department of Interventional Cardiology Chrzanów, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland;x. The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom;y. General Hospital of Northern Theater Command, Shenyang, Liaoning, China;z. Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland;11. Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy;22. Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos and Complutense University, Madrid, Spain;33. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom;44. London School of Hygiene and Tropical Medicine, London, United Kingdom
Abstract:ObjectivesThe aim of this study was to compare ticagrelor monotherapy with dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents.BackgroundThe role of abbreviated DAPT followed by an oral P2Y12 inhibitor after PCI remains uncertain.MethodsTwo 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.ResultsBleeding 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.ConclusionsTicagrelor monotherapy was associated with a lower risk for major bleeding compared with standard DAPT, without a concomitant increase in ischemic events.
Keywords:aspirin  DAPT  meta-analysis  ticagrelor  ACS"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0040"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  acute coronary syndrome(s)  BARC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0050"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Bleeding Academic Research Consortium  CCS"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0060"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  chronic coronary syndrome(s)  CEC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0070"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  clinical event committee  CI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0080"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  confidence interval  DAPT"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0090"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  dual-antiplatelet therapy  HR"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0100"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  hazard ratio  IPD"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0110"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  individual patient data  ITT"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0120"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  intention-to-treat  NNTB"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0130"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  number needed to treat for benefit  PCI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0140"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  percutaneous coronary intervention
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