Urology - The Gold Journal

Eikelboom - Evidence from the Randomized Trials - Figure 21
EINSTEIN-DVT and -PE: Pooled Analysis: Bleeding and Mortality

Because DVT and PE are two parts of the same spectrum of disease, Figure 21 shows the pooled data from the results for EINSTEIN DVT and EINSTEIN PE.[12]  Many patients with DVT have subclinical PE and many patients with PE have DVT – and both sets of patients are treated in the same way, and the results are very clear and compelling: 

In this population of patients treated upfront (immediately) with rivaroxaban at a dose of 15 mg twice daily for 3 weeks followed by 20 mg once daily, continued out to 6 months, rivaroxaban was associated with a similar efficacy to control (ie, warfarin, preceded by LMWH).  Rivaroxaban did not reduce major or non-major clinically relevant bleeding (compared to control), but it substantially reduced the risk of major bleeding by almost 50%.  All-cause mortality was similar in the two groups: it was not significantly reduced, although if anything, the pattern was in favor of the new oral anticoagulant.  

Importantly these pooled results for the first 3 to 6 months of treatment were obtained by starting immediately with the NOAC rivaroxaban versus starting with injectable LMWH and then transitioning to oral warfarinEikelboom J. Am J Med 2013; published on-line at http://education.amjmed.com/00000. 

References

[12] Büller HR; on behalf of the EINSTEIN Investigators. Oral rivaroxaban for the treatment of symptomatic venous thromboembolism: A pooled analysis of the EINSTEIN DVT and EINSTEIN PE studies. Blood (ASH Annual Meeting Abstracts). 2012;120:Abstract 20.