Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. EINSTEIN–PE Investigators, Büller HR, Prins MH, Lensin AW. Published in , EINSTEIN-PE randomized 4, patients with acute PE to rivaroxaban or standard therapy with enoxaparin and a VKA. Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism ().

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Among patients with acute PE, is rivaroxaban noninferior to warfarin in preventing recurrent VTE or bleeding? Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates.

At rivaeoxaban mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic VTE 2.


Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

Like the others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population. It differed from these studies in several notable ways, however.

To compensate for this, the study used a higher dose during the enistein 3 weeks of therapy 15mg BID followed by a lower maintenance dose 20mg daily. It was also one of the first to employ an open-label design lacking matching placebos between groups. Some of these characteristics contribute to the study’s limitations.

For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative rivqroxaban between treatment arms.

In addition, its open-label design may have biased both patients and investigators. The trial’s generalizability is limited for several reasons, including the fact that 1 patients were younger mean age 58 years than the general acute PE population and 2 the trial excluded patients with cancer.


Despite these limitations, there remains a reasonably strong evidence base for rivaroxaban in acute VTE, which led to the FDA approval of rivaroxaban for these indications in November ESC Guidelines on the diagnosis einsrein management of acute pulmonary embolismadapted: Comparisons are rivaroxaban vs.

P values are for noninferiority unless otherwise specified. The New England Journal of Medicine.

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

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