Rivaroxaban vs Dalteparin in Patients With Venous Thromboembolism
In a UK pilot trial (SELECT-D) reported in the Journal of Clinical Oncology, Young et al found that the oral factor Xa inhibitor rivaroxaban was associated with a lower rate of recurrent venous thromboembolism (VTE) but a higher rate of clinically relevant nonmajor bleeding compared with the low–molecular weight heparin dalteparin in cancer patients with VTE.
Study Details
In the open-label trial, screening between September 2013 and December 2016 led to recruitment of 406 patients with active cancer and VTE from 58 UK sites. Patients were randomized to oral rivaroxaban 15 mg twice daily for 3 weeks and then 20 mg once daily for a total of 6 months (n = 203) or subcutaneous dalteparin 200 IU/kg daily for 1 month and then 150 IU/kg daily for months 2 to 6 (n = 203). Patients had to have symptomatic pulmonary embolism, incidental pulmonary embolism, or symptomatic lower extremity proximal deep vein thrombosis. Overall, 58% of patients had metastatic disease.
The primary outcome was VTE recurrence over 6 months.
Recurrent VTE and Bleeding
Recurrent VTE was observed in 8 patients in the rivaroxaban group vs 18 in the dalteparin group, with 6-month cumulative VTE recurrence rates of 4% vs 11% (hazard ratio [HR] = 0.43, 95% confidence interval [CI] = 0.19–0.99). The 6-month cumulative rate of major bleeding was 6% vs 4% (HR = 1.83, 95% CI = 0.68–4.96), and the 6-month cumulative rate of clinically relevant nonmajor bleeding was 13% vs 4% (HR = 3.76, 95% CI = 1.63–8.69).
The investigators concluded, “Rivaroxaban was associated with relatively low VTE recurrence but higher [clinically relevant nonmajor bleeding] compared with dalteparin.”
The study was supported by Bayer AG.
Annie M. Young, PhD, of Warwick Medical School, University of Warwick, is the corresponding author for the Journal of Clinical Oncology article.
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