Portal de Periódicos da CAPES

Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

2022; Wiley; Volume: 11; Issue: 10 Linguagem: Inglês

10.1161/jaha.121.024291

2047-9980

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, Iván Horváth, Kurt Huber, Annemarie Hugense, Karim Ibrahim, Andrés Íñiguez, Karl Isaaz, Zoltán Jambrik, Luc Janssens, Pawel Jasionowicz, Judith Jonk, Werner Jung, Peter Jüni, Yuki Katagiri, Norihiro Kogame, Tian Hai Koh, René Köning, Mariana Konteva, Zsolt Kõszegi, Florian Krackhardt, Yvonne Kreuger, Neville Kukreja, Boudijn Ladan, Pierre Lantelme, Sergio Martins Leandro, Gregor Leibundgut, Christoph Liebetrau, Wietze Lindeboom, Carlos Macaya Miguel, François Mach, Michael Magro, Luc Maillard, Negar Manavifar, Laura Mauri, Eugène McFadden, Béla Merkely, Yosuke Miyazaki, Adam Młodziankowski, Tiziano Moccetti, Rodrigo Modolo, Helge Möllman, Jean‐François Morelle, Aris Moschovitis, Michael Munndt Ottesen, Martin Muurling, Christoph Naber, Franz‐Josef Neumann, Keith G. Oldroyd, Paul Jau Lueng Ong, Yoshinobu Onuma, Sanne Palsrok, Ivo Petrov, Sylvain Planté, Janusz Prokopczuk, Tessa Rademaker‐Havinga, C. Raffel, Benno Rensing, Marco Roffi, Kees‐Jan Royaards, Manel Sabaté, Volker Schächinger, Tim Seidler, Antonio Serra Peñaranda, Patrick W. Serruys, Lali Sikarulidze, Ton Slagboom, Osama Soliman, Amanda Sousa, Ernest Spitzer, Rod Stables, Philippe Gabríel Steg, Clemens Steinwender, Eduardas Subkovas, Harry Suryapranata, Kuniaki Takahashi, Suneel Talwar, Emmanuel Teíger, Addy ter Weele, Eva Teurlings, Attila Thury, Jan G.P. Tijssen, Gincho Tonev, Diana Trendafilova‐Lazarova, Carlo Tumscitz, Victor A. Umans, Imre Ungi, Veselin Valkov, Pim van der Harst, Robert‐Jan van Geuns, Cokky van Meijeren, Dobrin Vassilev, Vasil Velchev, Esther Velthuizen, Freek W.A. Verheugt, Natalia Vlcek, Jürgen vom Dahl, Mathias Vrolix, Simon Walsh, Nikos Werner, Stephan Windecker, Maarten Witsenburg, Azfar Zaman, Krzysztof Żmudka, Bernhard Zrenner, Aleksander Żurakowski, Robert Zweiker,

Pharmaceutical Economics and Policy

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. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.