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American Journal of Medicine
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American Journal of Medicine
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Unlike the trials with the direct thrombin inhibitor dabigatran (in the previous figures), the EINSTEIN program tested the other class of NOACs, the factor Xa inhibitor rivaroxaban for initial and long-term treatment of VTE. This was a very important trial program that differed from the dabigatran program in that treatment was started upfront with the new oral anticoagulant (without a period of heparin or LMWH). There were three trials, EINSTEIN DVT,[10] and EINSTEIN PE,[11] both of which tested rivaroxaban upfront compared with standard treatment (a combination of heparin and warfarin), and EINSTEIN Extension,[10] which tested rivaroxaban for long-term treatment against placebo (Figure 20).
The primary outcome in these trials was recurrent VTE and the primary safety outcome was bleeding; however, there were different definitions of bleeding in these trials. Eikelboom J. Am J Med 2013; published on-line at http://education.amjmed.com/00000.
[10] The EINSTEIN Investigators.. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363:2499-2510.
[11] EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366:1287-1297.