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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Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. Comment in N Engl J Med. At a mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic VTE 2.
Rivaroxaban was noninferior to standard therapy noninferiority margin, 2. In addition, its open-label riaroxaban may have biased both patients and investigators.
The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in The primary efficacy outcome was symptomatic recurrent venous thromboembolism. Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates.
This page was last modified on 3 Decemberat It was also one of the first to employ an open-label design lacking matching placebos between groups. It differed from these studies in several notable ways, however. Retrieved from ” http: Among patients with acute PE, is rivaroxaban noninferior to warfarin in preventing recurrent VTE or bleeding? In a randomized, open-label, event-driven, noninferiority trial involving patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban 15 mg twice daily for 3 weeks, followed by 20 mg once daily with standard therapy with enoxaparin followed by an adjusted-dose vitamin K einsten for 3, 6, or 12 months.
Major bleeding occured in 1. For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative efficacy between treatment arms.
This approach may also simplify the treatment of pulmonary embolism. The outcome of a net clinical benefit occurred in 83 patients 3. The principal safety outcome was major or clinically relevant nonmajor bleeding. A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, einsteiin the need for laboratory monitoring. Views Read View source View history.
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 The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group Close this section.
Rates of other adverse events were similar in the two groups. To compare rivaroxaban to standard anticoagulant therapy with enoxaparin and vitamin K antagonist VKA in the treatment of patients with acute symptomatic PE. The principal safety outcome occurred in N Engl J Med ; A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile.
Randomized, open-label phase III non-inferiority study Active treatment: Some of these characteristics contribute to the study’s limitations. rigaroxaban
Recommend page Back to top. P values are for noninferiority unless otherwise specified. The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group.
Usable articles Hematology Pulmonology. ESC Guidelines on the diagnosis and management of acute pulmonary embolismadapted: 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.
Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism Comparisons are rivaroxaban vs. The fixed dose regimen of rivaroxaban is at least as effective for the initial and long-term treatment of PE as the standard therapy with enoxaparin followed by a VKA Safety: To compensate for this, the study used a higher dose during the first 3 weeks of therapy 15mg BID followed by a lower maintenance dose 20mg daily.
N Engl J Med. The New England Journal of Medicine. Like the others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population. Navigation menu Personal tools Create account Log in. Major bleeding was observed in 26 patients 1.