Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/30784
Title: | Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial | Authors: | Tomaniak, Mariusz Chichareon, Ply Onuma, Yoshinobu Deliargyris, Efthymios N. Takahashi, Kuniaki Kogame, Norihiro Modolo, Rodrigo Chang, Chun Ching Rademaker-Havinga, Tessa Storey, Robert F. Dangas, George D. Bhatt, Deepak L. Angiolillo, Dominick J. Hamm, Christian Valgimigli, Marco Windecker, Stephan Steg, Philippe Gabriel VRANCKX, Pascal Serruys, Patrick W. Bertrand, Olivier F. Plante, Sylvain Van Geuns, Robert-Jan Hofma, Sjoerd H. Royaards, Kees-Jan Slagboom, Ton Suryapranata, Harry Umans, Victor A. W. M. Rensing, Benno van der Harst, Pim Magro, Michael Barbato, Emanuel Aminian, Adel BENIT, Edouard Janssens, Luc VROLIX, Mathias Buysschaert, Ian Carrie, Didier Barraud, Pascal Teiger, Emmanuel Koning, Ren Farzin, Beygui Morelle, Jean-francois Isaaz, Karl Maillard, Luc Abdellaoui, Mohamed Brunel, Philippe Angioi, Michael Lantelme, Pierre Sabate, Manel Albarran Gonzalez-Trevilla, Agustin Cequier, Angel Iiguez, Andres Serra Penaranda, Antonio Macaya Miguel, Carlos Francisco Diaz, Jose Hernndez Antolin, Rosa Ana Goicolea, Javier Ribeiro, Vasco Gama da Silva, Pedro Canas Ferreira, Rui Cruz Almeida, Manuel Ungi, Imre Merkely, Bela Fontos, Geza Horvath, Ivan Koszegi, Zsolt Jambrik, Zoltan Edes, Istvan Jozsef, Falukozy Colombo, Antonio Bolognese, Leonardo Ferrario, Maurizio Tumscitz, Carlo Dominici, Marcello Curello, Salvatore Roffi, Marco Eeckhout, Erik Moccetti, Tiziano Moschovitis, Aris Leibundgut, Gregor Huber, Kurt Frey, Bernhard Delle Karth, Georg Friedrich, Guy Steinwender, Clemens Zweiker, Robert Stables, Rod H. Anderson, Richard Chowdhary, Saqib Garg, Scot Hildick-Smith, David Fath-Ordoubadi, Farzin Oldroyd, Keith G. Galasko, Gavin Kukreja, Neville Zaman, Azfar Subkovas, Eduardas Curzen, Nick Hoole, Stephen Talwar, Suneel Walsh, Simon Adlam, David Cotton, James Holmvang, Lene Ottesen, Michael Munndt Buszman, Pawel Zurakowski, Aleksander Galuszka, Grzegorz Prokopczuk, Janusz Zmudka, Krzysztof Jasionowicz, Pawel Mlodziankowski, Adam Liebetrau, Christoph Naber, Christoph Kurt Neumann, Franz-Josef Schchinger, Volker Seidler, Tim Ibrahim, Karim Zrenner, Bernhard Gori, Tommaso Werner, Nikos Akin, Ibrahim Geisler, Tobias vom Dahl, Juergen Haude, Michael Eitel, Ingo Krackhardt, Florian Jung, Werner Lemos Neto, Pedro Alves Sousa, Amanda Quintella, Edgard Freitas Leandro, Sergio Botelho, Roberto Raffel, Christopher Barlis, Peter Hai, Koh Tian Ong, Paul Petrov, Ivo Konteva, Mariana Velchev, Vasil Gelev, Valeri Tonev, Gincho Valkov, Veselin Vassilev, Dobrin Trendafilova-Lazarova, Diana |
Issue Date: | 2019 | Publisher: | AMER MEDICAL ASSOC | Source: | JAMA Cardiology, 4(11),p.1092-1101 | Abstract: | ImportanceThe role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. ObjectiveTo evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and ParticipantsThis is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. InterventionsThe experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and MeasuresThe primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. ResultsOf 15968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P=.07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P=.004). Conclusions and RelevanceBetween 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. Trial RegistrationClinicalTrials.gov identifier: NCT01813435. | Notes: | Serruys, PW (reprint author), POB 2125, NL-3000 CC Rotterdam, Netherlands. patrick.w.j.c.serruys@gmail.com |
Other: | Serruys, PW (reprint author), POB 2125, NL-3000 CC Rotterdam, Netherlands. patrick.w.j.c.serruys@gmail.com | Keywords: | Dual Antiplatelet Therapy;In-Vitro;Clopidogrel;Intervention;Receptor;Plato | Document URI: | http://hdl.handle.net/1942/30784 | ISSN: | 2380-6583 | e-ISSN: | 2380-6591 | DOI: | 10.1001/jamacardio.2019.3355 | ISI #: | WOS:000501300400007 | Rights: | 2020 American Medical Association. All Rights Reserved. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
tomaniak2019.pdf Restricted Access | Published version | 417.63 kB | Adobe PDF | View/Open Request a copy |
SCOPUSTM
Citations
11
checked on Sep 2, 2020
WEB OF SCIENCETM
Citations
92
checked on Oct 13, 2024
Page view(s)
52
checked on Jul 20, 2022
Download(s)
4
checked on Jul 20, 2022
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.