MedicalResearch.com Interview with:
Prof Martin H Prins MD
Maastricht University Medical Centre, Maastricht, Netherlands
Medical Research: What are the main findings of the study?
Dr. Prins: Patients with active cancer, i.e. a cancer that was diagnosed or treated within 6 months before the episode, that was recurrent or metastatic, or that was diagnosed during treatment, who had a symptomatic episode of venous thromboembolism, were included in this pooled subgroup analysis of the Einstein DVT and PE studies. The incidence of recurrent venous thromboembolism was similar between groups. It occurred in 16 (5%) of 354 patients allocated to rivaroxaban and 20 (7%) of 301 patients allocated to enoxaparin and vitamin K antagonist (hazard ratio [HR] 0•67, 95% CI 0•35 to 1•30). Clinically relevant bleeding was also similar and occurred in 48 (14%) of 353 patients receiving rivaroxaban and in 49 (16%) of 298 patients receiving standard therapy (HR 0•80, 95% CI 0•54 to1•20). However, major bleeding was less frequent among rivaroxaban recipients and occurred in eight (2%) of 353 patients receiving rivaroxaban and in 15 (5%) of 298 patients receiving standard therapy (HR 0•42, 95% CI 0•18 to 0•99). Mortality was also similar.
Medical Research: What was most surprising about the results?
Dr. Prins: That the results for major bleeding were most favourable for major bleeding in those patients where you would expect a benefit of dose adjustment based on a coagulation parameter (INR) in the enoxaparin/vitamin K antagonist group, compared to a fixed, non-adjusted dose of rivaroxaban, namely in those who had a decreased renal function or were elderly. These conditions are frequent among cancer patients.
Medical Research: What should clinicians and patients take away from your report?
Dr. Prins: In patients with active cancer and venous thromboembolism, rivaroxaban can be considered as an alternative in those cases in which the attending physician would have given therapy including a vitamin K antagonist rather than long-term lowmolecular-weight heparin.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Prins: Based on these results in patients with cancer, a head-to-head comparison of rivaroxaban with long-term low-molecular-weight heparin is warranted.
Prof Martin H Prins MD,Anthonie W A Lensing MD,Tim A Brighton MBBS,Roger M Lyons MD,Jeffrey Rehm MD,Mila Trajanovic MD,Bruce L Davidson MD,Jan Beyer-Westendorf MD,Ákos F Pap MSc,Scott D Berkowitz MD,Alexander T Cohen MD,Prof Michael J Kovacs MD,Prof Philip S Wells MD,Prof Paolo Prandoni MD
The Lancet Haematology – 1 October 2014 ( Vol. 1, Issue 1, Pages e37-e46 )