Safe and effective use of rivaroxaban for treatment of cancer-associated venous thromboembolic disease: a prospective cohort study Journal Article


Authors: Mantha, S.; Laube, E.; Miao, Y.; Sarasohn, D. M.; Parameswaran, R.; Stefanik, S.; Brar, G.; Samedy, P.; Wills, J.; Harnicar, S.; Soff, G. A.
Article Title: Safe and effective use of rivaroxaban for treatment of cancer-associated venous thromboembolic disease: a prospective cohort study
Abstract: Low-molecular weight heparin (LMWH) has been the standard of care for treatment of venous thromboembolism (VTE) in patients with cancer. Rivaroxaban was approved in 2012 for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT), but no prior studies have been reported specifically evaluating the efficacy and safety of rivaroxaban for cancer-associated thrombosis (CAT). Under a Quality Assessment Initiative (QAI), we established a Clinical Pathway to guide rivaroxaban use for CAT and now report a validation analysis of our first 200 patients. A 200 patient cohort with CAT (PE or symptomatic, proximal DVT), whose full course of anticoagulation was with rivaroxaban, were accrued. In competing risk analysis, primary endpoints at 6 months included new or recurrent PE or symptomatic proximal lower extremity DVT, major bleeding, clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban, or death. In competing risk analysis, the 6 months cumulative incidence of new or recurrent VTE was 4.4 % (95 % CI = 1.4–7.4 %), major bleeding was 2.2 % (95 % CI = 0−4.2 %) and all-cause mortality 17.6 % (95 % CI = 11.7–23.0 %). In this cohort of 200 patients with active cancer and CAT the rates of new or recurrent VTE and major bleeding were comparable to the cancer subgroup analysis from the EINSTEIN studies. The results of our Clinical Pathway provide guidance on Rivaroxaban use for treatment of CAT, and suggest that safety and efficacy is preserved, compared with past-published experience with LMWH. © 2016, The Author(s).
Keywords: anticoagulation; venous thromboembolism; rivaroxaban; cancer
Journal Title: Journal of Thrombosis and Thrombolysis
Volume: 43
Issue: 2
ISSN: 0929-5305
Publisher: Springer  
Date Published: 2017-02-01
Start Page: 166
End Page: 171
Language: English
DOI: 10.1007/s11239-016-1429-1
PROVIDER: scopus
PMCID: PMC5318467
PUBMED: 27696084
DOI/URL:
Notes: Article -- Export Date: 4 April 2017 -- Source: Scopus
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MSK Authors
  1. Gerald A Soff
    86 Soff
  2. Simon H Mantha
    46 Mantha
  3. Patrick R. Samedy
    11 Samedy
  4. Jonathan   Wills
    23 Wills
  5. Yimei   Miao
    12 Miao
  6. Eva Simona Laube
    4 Laube