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Original Research: Antithrombotic Therapy |

Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension

Philip S. Wells, MD; Martin H. Prins, MD, PhD; Bennett Levitan, MD, PhD; Jan Beyer-Westendorf, MD; Timothy A. Brighton, MD; Henri Bounameaux, MD; Alexander T. Cohen, MD; Bruce L. Davidson, MD, MPH; Paolo Prandoni, MD, PhD; Gary E. Raskob, PhD; Zhong Yuan, MD, PhD; Eva G. Katz, PhD, MPH; Martin Gebel, PhD; Anthonie W.A. Lensing, MD, PhD
Author and Funding Information

FUNDING/SUPPORT: Drs Gebel and Lensing are paid employees of Bayer AG, and Drs Levitan, Yuan, and Katz are paid employees of Janssen Pharmaceutical Research & Development LLC and devoted salaried time to this work; the other authors were unsupported.

aDepartment of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, ON, Canada

bMaastricht University Medical Center, Maastricht, The Netherlands

cJanssen Pharmaceutical Research & Development LLC, Titusville, NJ

dDepartment of Vascular Medicine, University Hospital Carl-Gustav Carus, Dresden University of Technology, Dresden, Germany

eDepartment of Haematology, Prince of Wales Hospital, Sydney, NSW, Australia

fDivision of Angiology and Hemostasis, University Hospitals of Geneva and Faculty of Medicine, Geneva, Switzerland

gDepartment of Haematological Medicine, Guys and St Thomas’ Hospitals, King’s College Hospital, London, England

hSchool of Medicine, University of Washington, Seattle, WA

iDepartment of Cardiovascular Sciences, University of Padua, Padua, Italy

jCollege of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK

kJanssen Pharmaceutical Research & Development LLC, Raritan, NJ

lBayer AG, Wuppertal, Germany

CORRESPONDENCE TO: Philip S. Wells, MD, Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, 501 Smyth Rd, Ottawa, ON, Canada K1H 8L6


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;150(5):1059-1068. doi:10.1016/j.chest.2016.05.023
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Background  Short-term anticoagulant treatment for acute DVT or pulmonary embolism (PE) effectively reduces the risk of recurrent disease during the first 6 to 12 months of therapy. Continued anticoagulation often is not instituted because of the perception among physicians that the risk of major bleeding will outweigh the risk of new venous thrombotic episodes.

Methods  The authors performed a benefit-risk analysis by using the randomized EINSTEIN-Extension trial, which compared continued rivaroxaban with placebo in 1,197 patients with symptomatic DVT or PE who had completed 6 to 12 months of anticoagulation and in whom physicians had equipoise with respect to the need for continued anticoagulation. One-year Kaplan-Meier rates and rate differences of recurrent VTE and major bleeding were calculated. Benefits and risks were assessed using rate differences scaled to a population size of 10,000 patients treated for 1 year.

Results  Recurrent VTE occurred in eight recipients of rivaroxaban and 42 patients receiving placebo. In a population of 10,000 patients treated for 1 year, rivaroxaban treatment would have resulted in 665 (95% CI, 246-1,084) fewer recurrent VTEs than would placebo (number needed to treat = 15). Major bleeding occurred in four (0.7%) and zero patients, respectively. Rivaroxaban treatment would have resulted in 68 (95% CI, 2-134) more major bleeding events than would placebo (number needed to harm = 147). Kaplan-Meier analysis showed early recurrent VTE reduction with rivaroxaban that continued to improve throughout treatment; major bleeding increased gradually, plateauing at approximately 100 days.

Conclusions  A clinically important benefit and a favorable benefit-risk profile of continued rivaroxaban anticoagulation was observed.

Trial Registry  ClinicalTrials.gov; No.: NCT00439725; URL: www.clinicaltrials.gov

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