Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism

J. I. Weitz*, A. W. A. Lensing, M. H. Prins, R. Bauersachs, J. Beyer-Westendorf, H. Bounameaux, T. A. Brighton, A. T. Cohen, B. L. Davidson, H. Decousus, M. C. S. Freitas, G. Holberg, A. K. Kakkar, L. Haskell, B. van Bellen, A. F. Pap, S. D. Berkowitz, P. Verhamme, P. S. Wells, P. PrandoniEINSTEIN CHOICE Investigators

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BACKGROUND

Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin.

METHODS

In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding.

RESULTS

A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [ CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P

CONCLUSIONS

Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates.

Original languageEnglish
Pages (from-to)1211-1222
Number of pages12
JournalNew England Journal of Medicine
Volume376
Issue number13
DOIs
Publication statusPublished - 30 Mar 2017

Keywords

  • INTENSITY WARFARIN THERAPY
  • TOTAL KNEE ARTHROPLASTY
  • LONG-TERM
  • NONSURGICAL PATIENTS
  • ATRIAL-FIBRILLATION
  • HIP-ARTHROPLASTY
  • PREVENTION
  • ENOXAPARIN
  • THROMBOPROPHYLAXIS
  • THROMBOSIS

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