Apixaban with antiplatelet therapy after acute coronary syndrome

Alexander, John H., Lopes, Renato D., James, Stefan, Kilaru, Rakhi, He, Yaohua, Mohan, Puneet, Bhatt, Deepak L., Goodman, Shaun, Verheugt, Freek W., Flather, Marcus, Huber, Kurt, Liaw, Danny, Husted, Steen E., Lopez-Sendon, Jose, De Caterina, Raffaele, Jansky, Petr, Darius, Harald, Vinereanu, Dragos, Cornel, Jan H., Cools, Frank, Atar, Dan, Luis Leiva-Pons, Jose, Keltai, Matyas, Ogawa, Hisao, Pais, Prem, Parkhomenko, Alexander, Ruzyllo, Witold, Diaz, Rafael, White, Harvey, Ruda, Mikhail, Geraldes, Margarida, Lawrence, Jack, Harrington, Robert A. and Wallentin, Lars (2011) Apixaban with antiplatelet therapy after acute coronary syndrome. New England Journal of Medicine, 365 8: 699-708. doi:10.1056/NEJMoa1105819


Author Alexander, John H.
Lopes, Renato D.
James, Stefan
Kilaru, Rakhi
He, Yaohua
Mohan, Puneet
Bhatt, Deepak L.
Goodman, Shaun
Verheugt, Freek W.
Flather, Marcus
Huber, Kurt
Liaw, Danny
Husted, Steen E.
Lopez-Sendon, Jose
De Caterina, Raffaele
Jansky, Petr
Darius, Harald
Vinereanu, Dragos
Cornel, Jan H.
Cools, Frank
Atar, Dan
Luis Leiva-Pons, Jose
Keltai, Matyas
Ogawa, Hisao
Pais, Prem
Parkhomenko, Alexander
Ruzyllo, Witold
Diaz, Rafael
White, Harvey
Ruda, Mikhail
Geraldes, Margarida
Lawrence, Jack
Harrington, Robert A.
Wallentin, Lars
Title Apixaban with antiplatelet therapy after acute coronary syndrome
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2011-08-25
Sub-type Article (original research)
DOI 10.1056/NEJMoa1105819
Volume 365
Issue 8
Start page 699
End page 708
Total pages 10
Language eng
Subject 2700 Medicine
Abstract 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.) Copyright
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Journal Article
Sub-type: Article (original research)
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