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

Autor:	Silvain J; Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France., Lattuca B; ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France., Beygui F; ACTION Study Group, Département de Cardiologie, CHU de Caen, Caen, France., Rangé G; Département de Cardiologie, CH de Chartres, Chartres, France., Motovska Z; Third Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic., Dillinger JG; Université de Paris, Department of Cardiology, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, INSERM U942, Paris, France., Boueri Z; ACTION Study Group, Département de Cardiologie, CH de Bastia, Bastia, France., Brunel P; Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France., Lhermusier T; Département de Cardiologie, CHU de Toulouse, Toulouse, France., Pouillot C; Département de Cardiologie, Clinique Sainte Clotilde, La Réunion, France., Larrieu-Ardilouze E; Service de Cardiologie, CHU de Poitiers, Poitiers, France., Boccara F; AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France., Labeque JN; GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France., Guedeney P; Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France., El Kasty M; Département de Cardiologie, Grand Hôpital de l'Est Francilien site Marne-La-Vallée, Marne-la-Vallée, France., Laredo M; Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France., Dumaine R; Les Grands Prés Cardiac Rehabilitation Centre, Villeneuve St Denis, France., Ducrocq G; Université de Paris, Hôpital Bichat, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France., Collet JP; Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France., Cayla G; ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France., Blanchart K; ACTION Study Group, Département de Cardiologie, CHU de Caen, Caen, France., Kala P; University Hospital Brno, Medical Faculty of Masaryk University Brno, Brno, Czech Republic., Vicaut E; ACTION Study Group, Unité de Recherche Clinique, Hôpital Fernand Widal (AP-HP), Paris, France; Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France., Montalescot G; Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2020 Nov 28; Vol. 396 (10264), pp. 1737-1744. Date of Electronic Publication: 2020 Nov 14.
DOI:	10.1016/S0140-6736(20)32236-4
Abstrakt:	Background: 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. Methods: 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. Findings: 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). Interpretation: 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. Funding: ACTION Study Group and AstraZeneca. (Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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