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Article Dans Une Revue American Heart Journal Année : 2020

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

Benoît Lattuca
Ziad Boueri
  • Fonction : Auteur
Franck Boccara
Zuzana Motovska
  • Fonction : Auteur
Raphaëlle L. Dumaine
  • Fonction : Auteur
Éric Vicaut

Résumé

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 P2Y12 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. Methods: Assessment of Loading with the P2Y12 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). 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.
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Dates et versions

hal-02844082 , version 1 (15-06-2020)

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Johanne Silvain, Guillaume Cayla, Farzin Beygui, Grégoire Range, Benoît Lattuca, et al.. Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study. American Heart Journal, 2020, 225, pp.27-37. ⟨10.1016/j.ahj.2020.04.017⟩. ⟨hal-02844082⟩
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