Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes Insights From the APPRAISE-2 Trial

被引：37

作者：

Hess, Connie N. ^{[1
]}

James, Stefan ^{[2
]}

Lopes, Renato D. ^{[1
]}

Wojdyla, Daniel M. ^{[1
]}

Neely, Megan L. ^{[1
]}

Liaw, Danny ^{[3
]}

Hagstrom, Emil ^{[1
]}

Bhatt, Deepak L. ^{[4
,5
]}

Husted, Steen ^{[6
]}

Goodman, Shaun G. ^{[7
,8
]}

Lewis, Basil S. ^{[9
]}

Verheugt, Freek W. A. ^{[10
]}

De Caterina, Raffaele ^{[11
]}

Ogawa, Hisao ^{[12
]}

Wallentin, Lars ^{[2
]}

Alexander, John H. ^{[1
]}

机构：

[1] Duke Clin Res Inst, Duke Med, Durham, NC 27705 USA

[2] Uppsala Univ, Uppsala Clin Res Inst, Uppsala, Sweden

[3] Bristol Myers Squibb Co, Princeton, NJ USA

[4] Brigham & Womens Hosp Heart & Vasc Ctr, Boston, MA USA

[5] Harvard Univ, Sch Med, Boston, MA USA

[6] Arhus Univ Hosp, Aarhus, Denmark

[7] Univ Toronto, Canadian Heart Res Ctr, Toronto, ON, Canada

[8] Univ Toronto, St Michaels Hosp, Div Cardiol, Terrence Donnelly Heart Ctr, Toronto, ON, Canada

[9] Lady Davis Carmel Med Ctr, Dept Cardiovasc Med, Haifa, Israel

[10] Univ Med Ctr Nijmegen, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

[11] Univ G dAnnunzio, Inst Cardiol, Chieti, Italy

[12] Kumamoto Univ, Sch Med, Div Cardiol, Kumamoto, Japan

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2015年 / 66卷 / 07期

关键词：

acute coronary syndromes; antiplatelet therapy; antithrombotic therapy apixaban; MYOCARDIAL-INFARCTION; DOUBLE-BLIND; CLOPIDOGREL; ASPIRIN; RIVAROXABAN; MANAGEMENT; TICAGRELOR; WARFARIN; PLACEBO;

D O I：

10.1016/j.jacc.2015.06.027

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Bleeding limits anticoagulant treatment in patients with acute coronary syndromes (ACS). OBJECTIVES We investigated whether background concomitant antiplatelet therapy influences the effects of apixaban after ACS. METHODS This study examined high-risk ACS patients who were treated with aspirin or aspirin plus clopidogrel and who were randomized to apixaban 5 mg twice daily or placebo. In a post-hoc analysis, we assessed whether the effect of apixaban on efficacy and safety outcomes varied by the concomitant antiplatelet regimen by using simple Cox modeling and marginal structural models with propensity scores and antiplatelet therapy as a time-dependent covariate. RESULTS At baseline, of 7,364 patients, 16.3% (n = 1,202) were on aspirin alone, and 79.0% (n = 5,814) were on aspirin plus clopidogrel. A total of 19.2% (n = 1,415) switched antiplatelet therapy during follow-up. No differential effect of apixaban versus placebo was observed for the composite endpoint of cardiovascular death, myocardial infarction, and ischemic stroke in patients taking aspirin (12.21 per 100 patient-years vs. 13.21 per 100 patient-years; adjusted hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.62 to 1.32) or aspirin plus clopidogrel (13.22 vs. 14.24; adjusted HR: 0.95; 95% CI: 0.78 to 1.14; p(interaction) = 0.84). Compared with placebo, apixaban increased Thrombolysis In Myocardial Infarction major bleeding in patients taking aspirin (1.48 vs. 0.25; adjusted HR: 6.62; 95% CI: 0.75 to 51.73) and in patients taking aspirin plus clopidogrel (2.58 vs. 1.02; adjusted HR: 2.44; 95% CI: 1.34 to 4.45; p(interaction) = 0.41). Similar results were obtained with marginal structural models and in patients treated with and without percutaneous coronary intervention. CONCLUSIONS Post-ACS treatment with apixaban versus placebo showed no efficacy, but it increased bleeding regardless of concomitant therapy with aspirin alone or aspirin plus clopidogrel. (Apixaban for Prevention of Acute Ischemic Events 2 [APPRAISE-2]; NCT00831441) (J Am Coll Cardiol 2015; 66: 777-87) (C) 2015 by the American College of Cardiology Foundation.

引用

页码：777 / 787

页数：11

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