Effectiveness and Safety of Rivaroxaban in Patients with Cancer-Associated Venous Thromboembolism

Background: Venous thromboembolism (VTE), consisting of deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complication of both cancer and its treatment.Unlike low-molecular weight heparins (LMWHs) which represent the current standard-of-care for cancer-associated venous thromboembolism (CAT) management, rivaroxaban can be administered orally, avoiding the need for uncomfortable injections. While not guideline-recommended as first-line therapy for CAT, rivaroxaban has been used in routine clinical practice for this purpose.

Objective: To estimate the cumulative incidence of recurrent VTE, major bleeding and mortality in patients with CAT treated with rivaroxaban as outpatients in routine clinical practice.

Methods: Within US Truven MarketScan administrative claims data from 1/2012 to 6/2015, we identified adult patients with active cancer using National Cancer Institute-Surveillance, Epidemiology and End Results Program (NCI-SEER) coding who had ≥1 primary hospitalization or emergency department visit discharge diagnosis code for DVT and/or PE (the index event) and received a prescription of rivaroxaban as their first outpatient anticoagulant within 30-days of the index VTE. Eligible patients were required to have a minimum of 180-days continuous medical and prescription benefits prior to the index VTE (baseline period). Patients with a prior claim for VTE or receiving anticoagulation during the baseline period were excluded. We estimated the cumulative incidence with 95% confidence intervals (CIs) of recurrent VTE, major bleeding (identified per the Cunningham algorithm) and mortality (defined as in-hospital mortality or need for hospice care without subsequent claims) at 180-days assuming competing risks.

Results: A total of 949 active cancer patients were initiated on rivaroxaban following their index VTE. The mean ± standard deviation (SD) time from index VTE to first outpatient rivaroxaban fill was 4.4±5.8 days. Mean±SD age of identified patients was 62.5±12.8 years, 45.6% were men and PE (with or without DVT) was present in 43.6% of patients. Time from the diagnosis of active cancer to index CAT was ≤90-days in 30.0%, 91-180 days for 18.9% and 181-days of greater for 54.3% of patients. Cancer sites for this rivaroxaban-treated cohort were as follows: 25.5% breast, 21.0% genitourinary (including prostate), 13.2% hematologic, 13.2% colorectal, 11.5% lung, 7.4% gynecologic, 5.8% pancreas, 4.1% stomach/esophagus and 39.5% other. Metastatic disease was present in 42.6% of patients. During follow-up, there were 37 cases of recurrent VTE, 22 cases of major bleeding and 105 deaths. The 180-day cumulative incidence estimate was 4.0% (95%CI 2.8-5.4%) for recurrent VTE; 2.7% (95%CI=1.7−4.0%) for major bleeding and 11.3% (95%CI=9.2-13.6%) for mortality (Figure).

Conclusion: Event rates observed in this rivaroxaban treated cohort were consistent with those observed in prior studies of LMWH- and rivaroxaban-managed CAT patients. Our data may provide some reassurance to clinicians regarding the effectiveness and safety of rivaroxaban in treating CAT patients in routine outpatient practice.

View largeDownload slide

View largeDownload slide

Close modal