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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/27691

Title: Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial
Authors: Vranckx, Pascal
Valgimigli, Marco
Juni, Peter
Hamm, Christian
Steg, Philippe Gabriel
Heg, Dik
van Es, Gerrit Anne
McFadden, Eugene P.
Onuma, Yoshinobu
van Meijeren, Cokky
Chichareon, Ply
Benit, Edouard
Mollmann, Helge
Janssens, Luc
Ferrario, Maurizio
Moschovitis, Aris
Zurakowski, Aleksander
Dominici, Marcello
Van Geuns, Robert Jan
Huber, Kurt
Slagboom, Ton
Serruys, Patrick W.
Windecker, Stephan
Issue Date: 2018
Citation: LANCET, 392(10151), p. 940-949
Abstract: Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved.
Notes: [Vranckx, Pascal; Benit, Edouard] Hasselt Univ, Fac Med & Life Sci, Jessa Ziekenhuis, Hasselt, Belgium. [Valgimigli, Marco; Moschovitis, Aris; Windecker, Stephan] Univ Bern, Bern Univ Hosp, Inselspital, Dept Cardiol, Bern, Switzerland. [Juni, Peter] Univ Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada. [Juni, Peter] Univ Toronto, Dept Med, Toronto, ON, Canada. [Juni, Peter] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada. [Hamm, Christian; Mollmann, Helge] Kerckhoff Heart & Thorax Ctr, Bad Nauheim, Germany. [Steg, Philippe Gabriel] Univ Paris Diderot, Hop Bichat, AP HP, INSERM,U 1148,French Alliance Cardiovasc Trials, Paris, France. [Steg, Philippe Gabriel] Imperial Coll London, Royal Brompton Hosp, Natl Heart & Lung Inst, London, England. [Heg, Dik] Univ Bern, Inst Social & Prevent Med, Bern, Switzerland. [van Es, Gerrit Anne] European Cardiovasc Res Inst, Rotterdam, Netherlands. [McFadden, Eugene P.] Cork Univ Hosp, Cork, Ireland. [Onuma, Yoshinobu; Van Geuns, Robert Jan; Serruys, Patrick W.] Erasmus MC, Rotterdam, Netherlands. [Onuma, Yoshinobu; van Meijeren, Cokky] Cardialysis, Rotterdam, Netherlands. [Chichareon, Ply; Serruys, Patrick W.] Acad Med Ctr Amsterdam, Amsterdam, Netherlands. [Janssens, Luc] Imeldaziekenhuis, Bonheiden, Belgium. [Ferrario, Maurizio] Fdn IRCCS Policlin San Matteo, UOC Cardiol, Pavia, Italy. [Zurakowski, Aleksander] Amer Heart Poland, Ctr Cardiovasc Res & Dev, Katowice, Poland. [Dominici, Marcello] Azienda Osped S Maria, Terni, Italy. [Huber, Kurt] Wilhelminenhospital, Dept Med Cardiol & Intens Care Med 3, Vienna, Austria. [Huber, Kurt] Sigmund Freud Univ, Med Fac, Vienna, Austria. [Slagboom, Ton] Onze Lieve Vrouw Hosp, Amsterdam, Netherlands.
URI: http://hdl.handle.net/1942/27691
DOI: 10.1016/S0140-6736(18)31858-0
ISI #: 000444475700026
ISSN: 0140-6736
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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