A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study

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• 作者：Luca A. Ferri ; MD^a ; Nuccia Morici ; MD^b ; Daniele Grosseto ; MD^c ; Giovanni Tortorella ; MD^d ; Irene Bossi ; MD^b ; Paolo Sganzerla ; MD^e ; Michele Cacucci ; MD^f ; Girolamo Sibilio ; MD^g ; Stefano Tondi ; MD^h ; Anna Toso ; MDⁱ ; Maurizio Ferrario ; MD^j ; Nicola Gandolfo^k ; Amelia Ravera ; MD^l ; Matteo Mariani ; MD^m ; Elena Corrada ; MDⁿ ; Leonardo Di Ascenzo ; MD^o ; Anna Sonia Petronio ; MD^p ; Claudio Cavallini ; MD^q ; Nadia Moffa ; BSc^r ; Stefano De Servi ; MD^s ; Stefano Savonitto ; MD^a ; ^{s.savonitto@asst-lecco.it" class="auth_mail" title="E-mail the corresponding author}
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：181
• 期：Complete
• 页码：101-106
• 全文大小：193 K

文摘

Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5 mg has been shown to provide more predictable and homogenous antiplatelet effect, as compared with clopidogrel, suggesting the possibility of reducing ischemic events after an acute coronary syndrome (ACS) without increasing bleeding.

Study design

The Elderly-ACS 2 study is a multicenter, randomized, parallel-group, open-label trial designed to demonstrate the superiority of a strategy of dual antiplatelet treatment using a reduced 5-mg daily dose of prasugrel over a standard strategy with a daily clopidogrel dose of 75 mg in patients older than 74 years with ACS (either ST- or non–ST-elevation myocardial infarction) undergoing early percutaneous revascularization. The primary end point is the composite of all-cause mortality, myocardial reinfarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. Taking advantage of the planned size of 2,000 patients, the secondary objective is to assess the prognostic impact of selected prerandomization variables (age, sex, diabetic status, serum creatinine level, electrocardiogram changes, abnormal troponin levels, basal and residual SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery [SYNTAX] score).

Conclusion

The Elderly-ACS 2 study is a multicenter, randomized trial comparing a strategy of dual antiplatelet therapy with a reduced dose of prasugrel with a standard dose of clopidogrel in elderly patients with ACS undergoing percutaneous revascularization (the Elderly ACS 2 trial: f" data-locatorType="ctgov" data-locatorKey="NCT01777503">NCT01777503).