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Title: | Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial | Authors: | Gragnano, Felice Zwahlen, Marcel VRANCKX, Pascal Heg, Dik Schmidlin, Kurt Hamm, Christian Steg, Philippe Gabriel Gargiulo, Giuseppe McFadden, Eugene P. Onuma, Yoshinobu Chichareon, Ply Mollmann, Helge BENIT, Edouard Janssens, Luc Leonardi, Sergio Zurakowski, Aleksander Arrivi, Alessio van Geuns, Robert Jan Huber, Kurt Slagboom, Ton Calabro, Paolo Serruys, Patrick W. Juni, Peter Valgimigli, Marco Windecker, Stephan |
Issue Date: | 2022 | Publisher: | WILEY | Source: | Journal of the American Heart Association, 11 (10) (Art N° e024291) | Abstract: | BACKGROUND: In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. METHODS AND RESULTS: Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03; P=0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26; P=0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. CONCLUSIONS: Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. | Notes: | Windecker, S (corresponding author), Bern Univ Hosp, Dept Cardiol, Inselspital, CH-3010 Bern, Switzerland. stephan.windecker@insel.ch |
Keywords: | DAPT; intention-to-treat; P2Y(12); inhibitor monotherapy; per-protocol;;ticagrelor | Document URI: | http://hdl.handle.net/1942/37533 | e-ISSN: | 2047-9980 | DOI: | 10.1161/JAHA.121.024291 | ISI #: | WOS:000796637400002 | Rights: | This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2023 |
Appears in Collections: | Research publications |
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JAHA.121.024291.pdf | Published version | 1.63 MB | Adobe PDF | View/Open |
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