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J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.

Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial.

Journal of the American Heart Association

Pascal Vranckx, Marco Valgimigli, Ayodele Odutayo, Patrick W Serruys, Christian Hamm, Philippe Gabriel Steg, Dik Heg, Eugene P Mc Fadden, Yoshinobu Onuma, Edouard Benit, Luc Janssens, Roberto Diletti, Maurizio Ferrario, Kurt Huber, Lorenz Räber, Stephan Windecker, Peter Jüni,

Affiliations

  1. Jessa Ziekenhuis Faculty of Medicine and Life Sciences at the Hasselt University Hasselt Belgium.
  2. Department of Cardiology University of BernInselspital Bern Switzerland.
  3. Department of Medicine and Institute of Health Policy, Management and Evaluation Applied Health Research CentreLi Ka Shing Knowledge Institute of St. Michael's HospitalUniversity of Toronto Canada.
  4. Imperial College London London United Kingdom.
  5. Kerckhoff Heart and Thorax Center Bad Nauheim Germany.
  6. INSERM U-1148 FACT (French Alliance for Cardiovascular Trials) Hôpital BichatAssistance Publique-Hôpitaux de ParisUniversité de Paris France.
  7. National Heart and Lung InstituteRoyal Brompton HospitalImperial College London United Kingdom.
  8. Clinical Trials Unit University of Bern Switzerland.
  9. Cork University Hospital Cork Ireland.
  10. Cork University Hospital Wilton, Cork Ireland.
  11. Cardialysis Rotterdam The Netherlands.
  12. Erasmus Medical Center Rotterdam The Netherlands.
  13. Imeldaziekenhuis Bonheiden Belgium.
  14. UOC Cardiologia Fondazione IRCCS Policlinico San Matteo Pavia Italy.
  15. 3rd Department of Medicine, Cardiology and Intensive Care Medicine Medical Faculty Wilhelminen Hospital and Sigmund Freud University Vienna Austria.

PMID: 34533034 DOI: 10.1161/JAHA.119.015560

Abstract

Background The optimal duration of dual antiplatelet therapy after coronary drug-eluting stent placement in adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS) remains uncertain. Methods and Results This was a prespecified subgroup analysis of the GLOBAL LEADERS trial. Participants were randomly assigned 1:1 to the experimental or reference strategy, stratified by ACS (experimental, n=3750; reference, n=3737) versus SCAD (experimental, n=4230; reference, n=4251). The experimental strategy was 75 to 100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy. The reference strategy was 75 to 100 mg aspirin daily plus either 75 mg clopidogrel daily (for SCAD) or 90 mg ticagrelor twice daily (for ACS) for 12 months, followed by aspirin monotherapy for 12 months. The primary end point at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction. The key secondary safety end point was site-reported Bleeding Academic Research Consortium grade 3 or 5 bleeding. The primary end point occurred in 147 (3.92%) versus 169 (4.52%) patients with ACS (rate ratio [RR], 0.86; 95% CI, 0.69-1.08;

Keywords: acute coronary syndrome; all‐comers; antiplatelet therapy; coronary; intervention; stable coronary artery disease; ticagrelor

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