Back to Search Start Over

Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.

Authors :
Silvain J
Cayla G
Beygui F
Range G
Lattuca B
Collet JP
Dillinger JG
Boueri Z
Brunel P
Pouillot C
Boccara F
Christiaens L
Labeque JN
Lhermusier T
Georges JL
Bellemain-Appaix A
Le Breton H
Hauguel-Moreau M
Saint-Etienne C
Caussin C
Jourda F
Motovska Z
Guedeney P
El Kasty M
Laredo M
Dumaine R
Ducrocq G
Vicaut E
Montalescot G
Source :
American heart journal [Am Heart J] 2020 Jul; Vol. 225, pp. 27-37. Date of Electronic Publication: 2020 Apr 29.
Publication Year :
2020

Abstract

Background: 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 <subscript>12</subscript> 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.<br />Methods: Assessment of Loading with the P2Y <subscript>12</subscript> 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).<br />Conclusion: 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.<br /> (Copyright © 2020 Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1097-6744
Volume :
225
Database :
MEDLINE
Journal :
American heart journal
Publication Type :
Academic Journal
Accession number :
32473356
Full Text :
https://doi.org/10.1016/j.ahj.2020.04.017