Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/30401
Title: | Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting | Authors: | Franzone, Anna McFadden, Eugene Leonardi, Sergio Piccolo, Raffaele VRANCKX, Pascal Serruys, Patrick W. BENIT, Edouard Liebetrau, Christoph Janssens, Luc Ferrario, Maurizio Zurakowski, Aleksander Diletti, Roberto Dominici, Marcello Huber, Kurt Slagboom, Ton Buszman, Pawel Bolognese, Leonardo Tumscitz, Carlo Bryniarski, Krzysztof Aminian, Adel VROLIX, Mathias Petrov, Ivo Garg, Scot Naber, Christoph Prokopczuk, Janusz Hamm, Christian Steg, Philippe Gabriel Heg, Dik Juni, Peter Windecker, Stephan Valgimigli, Marco |
Issue Date: | 2019 | Publisher: | ELSEVIER SCIENCE INC | Source: | JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 74 (18) , p. 2223 -2234 | Abstract: | BACKGROUND The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported. OBJECTIVES This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. METHODS An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites. RESULTS The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention. CONCLUSIONS Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059). (C) 2019 by the American College of Cardiology Foundation. | Notes: | Valgimigli, M (reprint author), Univ Bern, Bern Univ Hosp, Bern Inselspital, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland. marco.valgimigli@insel.ch |
Keywords: | adjudication;dual antiplatelet therapy;percutaneous coronary intervention;ticagrelor | Document URI: | http://hdl.handle.net/1942/30401 | ISSN: | 0735-1097 | e-ISSN: | 1558-3597 | DOI: | 10.1016/j.jacc.2019.08.1038 | ISI #: | WOS:000493390700001 | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
Show full item record
SCOPUSTM
Citations
14
checked on Sep 7, 2020
WEB OF SCIENCETM
Citations
104
checked on Oct 14, 2024
Page view(s)
80
checked on Jul 2, 2023
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.