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Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome

Open access
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, Leiva-Pons, Jose Luis, 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·2011·New England Journal of 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.).

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Metadata

Authors
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.
Venue
New England Journal of Medicine
Published
2011-08-25
Volume
365
Issue
8
Pages
699-708
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2108064339
Cited by
1,005
References
6
FWCI
85.93
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome. https://app.cochat.ai/papers/10.1056/nejmoa1105819
The paper
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., . . . Wallentin, L. (2011). Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1105819

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.