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Apixaban with antiplatelet therapy after acute coronary syndrome.

Publication ,  Journal Article
Alexander, JH; Lopes, RD; James, S; Kilaru, R; He, Y; Mohan, P; Bhatt, DL; Goodman, S; Verheugt, FW; Flather, M; Huber, K; Liaw, D; Jansky, P ...
Published in: N Engl J Med
August 25, 2011

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 25, 2011

Volume

365

Issue

8

Start / End Page

699 / 708

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Pyridones
  • Pyrazoles
  • Proportional Hazards Models
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
 

Citation

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Alexander, J. H., Lopes, R. D., James, S., Kilaru, R., He, Y., Mohan, P., … APPRAISE-2 Investigators, . (2011). Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med, 365(8), 699–708. https://doi.org/10.1056/NEJMoa1105819
Alexander, John H., Renato D. Lopes, Stefan James, Rakhi Kilaru, Yaohua He, Puneet Mohan, Deepak L. Bhatt, et al. “Apixaban with antiplatelet therapy after acute coronary syndrome.N Engl J Med 365, no. 8 (August 25, 2011): 699–708. https://doi.org/10.1056/NEJMoa1105819.
Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, et al. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699–708.
Alexander, John H., et al. “Apixaban with antiplatelet therapy after acute coronary syndrome.N Engl J Med, vol. 365, no. 8, Aug. 2011, pp. 699–708. Pubmed, doi:10.1056/NEJMoa1105819.
Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L, APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699–708.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 25, 2011

Volume

365

Issue

8

Start / End Page

699 / 708

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Pyridones
  • Pyrazoles
  • Proportional Hazards Models
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate