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Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial

2020; Elsevier BV; Volume: 396; Issue: 10264 Linguagem: Inglês

10.1016/s0140-6736(20)32236-4

1474-547X

Johanne Silvain, Benoît Lattuca, Farzin Beygui, Grégoire Rangé, Zuzana Moťovská, Jean‐Guillaume Dillinger, Ziad Boueri, Philippe Brunel, Thibault Lhermusier, Christophe Pouillot, Elisa Larrieu-Ardilouze, Franck Boccara, Jean-Noël Labeque, Paul Guedeney, Mohamad El Kasty, Mikaël Laredo, Raphaëlle Dumaine, Grégory Ducrocq, Jean‐Philippe Collet, Guillaume Cayla, Katrien Blanchart, Petr Kala, Eric Vicaut, Gilles Montalescot, Johanne Silvain, J.‐P. Collet, Gilles Montalescot, Mathieu Kerneïs, N. Braïk, Olivier Barthélémy, G Helft, C. Lefeuvre, R. Choussat, Marie Hauguel, Michel Zeitouni, Thomas Cuisset, Jean-Louis Bonnet, Pierre Deharo, Benoît Lattuca, Guillaume Cayla, Luc Cornillet, Bertrand Ledermann, Clément Lonjon, Laurent Schmutz, Grégoire Rangé, Franck Albert, Thibault Demicheli, Laurent Roussel, R. Bensaid, Christophe Thuaire, Jean-Guillaume DILLINGER, Patrick Henry, Stéphane Manzo‐Silberman, Giorgos Sideris, Damien Logeart, Vincent Spagnoli, Leoš Pleva, Christophe Pouillot, Jean Richard VI-FANE, Jens Glasenapp, K. Bougrini, Nicolas Combaret, Pascal Motreff, Géraud Souteyrand, Aimé Amonchot, Thomas Mouyen, Thibault Lhermusier, Didier Carrié, Frédéric Bouisset, Thomas Chollet, Francisco CAMPELO-PARADA, Nicolas Delarche, François Schiele, Matthieu Besutti, Marie Hauguel‐Moreau, Marian Branny, Christophe Caussin, Malak A. Zoheir, Aurélie Veugeois, Alain Dibié, Olivier Varenne, Fabien Picard, A. Lafont, Julien Adjedj, Philippe Degrell, Farzin Beygui, Rémi Sabatier, Vincent Roule, M Bignon, Katrien Blanchart, P Ardouin, Adrien Lemaître, Clément Briet, Ziad Boueri, Pascal Goube, Pierre Coste, Laura Cetran, Jérôme Clerc, Hervé Breton, Dominique Boulmier, Vincent Auffret, J.N. Labèque, Jean-Luc BONAS, Jean‐Louis Georges, B. Livarek, E. Blicq, N. Baron, G. Gibault‐Genty, Yves Cottin, Isabelle L’Huillier, Carole Richard, Luc Lorgis, Philippe Buffet, Christian Spaulding, Nicole Karam, Étienne Puymirat, Marco Mennuni, Emmanouil Poulidakis, L. Bonnevie, Franck Boccara, Marion Chauvet, Laurie Soulat-Dufour, Yann Ancédy, Stephane Ederhy, Arnaud Etienney, Anne Bellemain‐Appaix, Nathaniel Bitton, Laurent Jacq, Christophe Saint‐Etienne, Florence Leclercq, François ROUBILLE, Gilles Rioufol, François Dérimay, M. Goralski, W. El Yafi, Emmanuelle Filippi, A. Kermarrec, Christophe Le Ray, Antoine Merlet, Aurélie Loirat, Philippe Brunel, Damien Brunet, J. Ravisy, L. Mock, G. Molins, Benjamin Faurie, Erwan Bressollette, L Christiaens, Elisa Larrieu-Ardilouze, J E Poulard, Éric Van Belle, Gilles Lemesle, C Delhaye, Flavien Vincent, Sina Porouchani, Hugues Spillemaeker, K. Didier Petit, Olivier Ressencourt, Benjamin Faurie, V. Humeau, François Jourda, Marc‐Antoine Arnould, S. Chassaing, Karl Isaaz, Laurent Payot, Jacques MONTSEGU, Benjamin Faurie, Michel Pansiéri, M Metge, Karim Moussa, Mathieu Pankert, Olivier Morel, Sébastien Hess, L. Maillard, Thibault Manigold, Vincent Letocart, Julien Plessis, P. Berthome, Mickael Bonin, Martin Poloczek, Emmanuel Teíger, Romain Gallet, Gauthier Mouillet, Madjid Boukantar, Marian Branny, Mohammed Nejjari, David Attias, Leoš Pleva, Manuela Steinecker, Martin Poloczek, Zuzana Moťovská, Martin Kozel, Zdenko Stelmach, Ota Hlinomaz, Marwa Rezek, Martin Novák, Jan Sitar, Jiří Seménka, Petr Kala, Otakar Boček, Roman Štípal, Martin Poloczek, Jan Kaňovský, Petr Jeřábek, Jiří Karásek, Sylvie HRUSKOVA, Marian Branny, Jan Mrózek, Tomáš Grézl, Leoš Pleva, Pavel Kukla, Martin Porzer,

Coronary Interventions and Diagnostics

Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.ACTION Study Group and AstraZeneca.