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Permanent URL to this publication: http://dx.doi.org/10.5167/uzh-61262

Alexander, J H; Lopes, R D; James, S; Kilaru, R; He, Y; Mohan, P; Bhatt, D L; Goodman, S; Verheugt, F W; Flather, M; Huber, K; Liaw, D; Husted, S E; Lopez-Sendon, J; De Caterina, R; Jansky, P; Darius, H; Vinereanu, D; Cornel, J H; Cools, F; Atar, D; Leiva-Pons, J L; Keltai, M; Ogawa, H; Pais, P; Parkhomenko, A; Ruzyllo, W; Diaz, R; White, H; Ruda, M; Geraldes, M; Lawrence, J; Harrington, R A; Wallentin, L (2011). Apixaban with antiplatelet therapy after acute coronary syndrome. New England Journal of Medicine, 365(8):699-708.

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Background: Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome. Methods: We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events. Results: The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events. With a median follow-up of 241 days, the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 279 of the 3705 patients (7.5%) assigned to apixaban (13.2 events per 100 patient-years) and in 293 of the 3687 patients (7.9%) assigned to placebo (14.0 events per 100 patient-years) (hazard ratio with apixaban, 0.95; 95% confidence interval [CI], 0.80 to 1.11; P=0.51). The primary safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition occurred in 46 of the 3673 patients (1.3%) who received at least one dose of apixaban (2.4 events per 100 patient-years) and in 18 of the 3642 patients (0.5%) who received at least one dose of placebo (0.9 events per 100 patient-years) (hazard ratio with apixaban, 2.59; 95% CI, 1.50 to 4.46; P=0.001). A greater number of intracranial and fatal bleeding events occurred with apixaban than with placebo. Conclusions: The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events. (Funded by Bristol-Myers Squibb and Pfizer; APPRAISE-2 ClinicalTrials.gov number, NCT00831441.).


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Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiology
Dewey Decimal Classification:610 Medicine & health
Deposited On:15 Mar 2012 14:28
Last Modified:04 Dec 2013 04:31
Publisher:Massachusetts Medical Society
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:10.1056/NEJMoa1105819
PubMed ID:21780946

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