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Get Free AccessBackground 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. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.
Felice Gragnano, Marcel Zwahlen, Pascal Vranckx, Dik Heg, Kurt Schmidlin, Christian W. Hamm, Philippe Gabríel Steg, Giuseppe Gargiulo, Eugène McFadden, Yoshinobu Onuma, Ply Chichareon, Edouard Benit, Helge Möllmann, Luc Janssens, Sergio Leonardi, Aleksander Żurakowski, Alessio Arrivi, Robert‐Jan van Geuns, Kurt Huber, Ton Slagboom, Paolo Calabrò, Patrick W. Serruys, Peter Jüni, Marco Valgimigli, Stephan Windecker, Mohamed Abdellaoui, David Adlam, İbrahim Akın, Agustín Albarrán González-Trevilla, Manuel Almeida, Pedro A. Lemos, Adel Aminian, Richard Anderson, Rick Andreae, Michaël Angioı̈, Taku Asano, Emanuele Barbato, Peter Barlis, Pascal Barraud, Edouard Benit, Olivier F. Bertrand, Farzin Beygui, Leonardo Bolognese, Roberto Botelho, Coby Bouwman, Marco Bressers, Philippe Brunel, Paweł Buszman, Ian Buysschaert, Pedro Canas da Silva, Didier Carrié, Ángel Cequier, Ply Chichareon, Chun Chin Chang, Saqib Chowdhary, Carlos Collet, Antonio Colombo, James Cotton, Rui Cruz Ferreira, Salvatore Curello, Nick Curzen, Judith de Bot, Tone de Vreede, Georg Delle Karth, Lynn Dijksma, Marcello Dominici, István Édes, Éric Eeckhout, Ingo Eitel, József Faluközy, Farzin Fath‐Ordoubadi, Maurizio Ferrario, Géza Fontos, José Francisco Díaz Fernández, Edgard Freitas Quintella, Bernhard Frey, Guy Friedrich, Gavin Galasko, G. Gałuszka, Vasco Gama Ribeiro, Scot Garg, Giuseppe Gargiulo, Tobias Geisler, Валери Гелев, Art Ghandilyan, Javier Goicolea, Tommaso Gori, Felice Gragnano, Ana Guimarães, Christian W. Hamm, Michael Haude, Dik Heg, Pieter Heijke, Rosa Ana Hernández Antolín, David Hildick‐Smith, Dorien Hillen, Ina Hoekman, Sjoerd H. Hofma, Lene Holmvang, Stephen P. Hoole (2022). Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial. Journal of the American Heart Association, 11(10), DOI: 10.1161/jaha.121.024291.
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Type
Article
Year
2022
Authors
100
Datasets
0
Total Files
0
Language
English
Journal
Journal of the American Heart Association
DOI
10.1161/jaha.121.024291
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