Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting.
Assessment of Loading with the P2Y inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier).
ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.
Copyright © 2020 Elsevier Inc. All rights reserved.
About The Expert
Johanne Silvain
Guillaume Cayla
Farzin Beygui
Grégoire Range
Benoit Lattuca
Jean-Philippe Collet
Jean-Guillaume Dillinger
Ziad Boueri
Philippe Brunel
Christophe Pouillot
Franck Boccara
Luc Christiaens
Jean-Noël Labeque
Thibault Lhermusier
Jean-Louis Georges
Anne Bellemain-Appaix
Hervé Le Breton
Marie Hauguel-Moreau
Christophe Saint-Etienne
Christophe Caussin
François Jourda
Zuzana Motovska
Paul Guedeney
Mohamad El Kasty
Mikael Laredo
Raphaëlle Dumaine
Grégory Ducrocq
Eric Vicaut
Gilles Montalescot
References
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