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Evidence has shown that patients hospitalized with acute medical conditions such as a recent infection, ischemic stroke, myocardial infarction or active cancer are at an increased risk for venous thromboembolism (VTE) during hospitalization and after discharge.1,2 To date, one trial has evaluated the effectiveness of extended-duration thromboprophylaxis (i.e. prophylaxis continued for up to 35 days) after discharge in medically ill patients.3 The EXCLAIM trial showed that extended-duration prophylaxis with enoxaparin reduced VTE but with an increase in major bleeding.3 The American College of Chest Physicians (ACCP) clinical practice guidelines recommends that acutely ill patients at high risk for VTE receive chemical thromboprophylaxis until they are mobile or are discharged from the hospital, whichever comes first.2 Based on the results from the EXCLAIM trial, the ACCP recommends against the use of extended thromboprophylaxis beyond the acute hospitalization or period of immobilization.2 Rivaroxaban (Xarelto®) is a direct, reversible factor Xa inhibitor approved for VTE prevention in adults undergoing elective hip- or knee-replacement surgery, VTE treatment, and stroke prevention in non-valvular atrial fibrillation. The MAGELLAN trial was conducted to evaluate the safety and efficacy of oral rivaroxaban for VTE prophylaxis in acutely ill patients for a standard duration and an extended-duration.4 

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The MAGELLAN trial was a randomized, double-blind, double-dummy non-inferiority trial comparing oral rivaroxaban 10 mg once daily to subcutaneous enoxaparin 40 mg once daily for 10±4 days.4 In addition, a superiority analysis was performed to compare rivaroxaban 10 mg once daily continued for 35±4 days to oral placebo for 35±4 days after subcutaneous enoxaparin 40 mg once daily for 10±4 days. Inclusion criteria consisted of patients who were 40 years or older and at high risk for a VTE event (with a specified acute medial illness and reduced mobility) during hospitalization. The primary efficacy endpoint in the study was a composite of asymptomatic proximal deep-vein thrombosis, symptomatic proximal or distal deep-vein thrombosis, symptomatic nonfatal pulmonary embolism or VTE-related death. The secondary efficacy endpoint was the same as the primary endpoint with the addition of all-cause mortality. The primary safety endpoint was a composite of clinically relevant major or nonmajor bleeding observed < 2 days following the last study medication dose. Major bleeding was defined as a decline in hemoglobin ≥ 2 g/dL, transfusions requiring ≥ 2 units of blood or death-related bleeds. A net clinical benefit or harm analysis was performed comparing a composite of the primary efficacy endpoints or primary safety endpoints for days 10±4 and 35±4.4

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The study randomized 8,101 patients to the two study groups, with a follow-up time of 90 days and median hospitalization duration of 11 days.4 Baseline characteristics were similar between the groups with a median age of 71 years, with 30% of patients having two or more acute medical conditions (i.e. active cancer, recent infection, heart failure, ischemic stroke) and 60% of patients with a CrCl ≤ 80 ml/min.4,5 For standard duration of therapy (10±4 days), rivaroxaban was shown to be non-inferior to enoxaparin (2.7% vs. 2.7% respectively, P=0.03 for non-inferiority). Extended use of rivaroxaban (35±4 days) was shown to be superior to enoxaparin ...

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