MAGELLAN
Trial question
Is rivaroxaban noninferior to enoxaparin for thromboprophylaxis in acutely ill medical patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 8101
8101 patients (3712 female, 4389 male).
Inclusion criteria: patients ≥ 40 years of age who were hospitalized for an acute medical illness.
Key exclusion criteria: contraindication for LMWH enoxaparin, risk of bleeding, known allergy to rivaroxaban, severe renal insufficiency, known HIV infection at screening, or history of ongoing drug or alcohol abuse.
Interventions
N=4050 rivaroxaban (subcutaneous placebo for 10 +/- 4 days and oral rivaroxaban, 10 mg once daily, for 35 +/- 4 days).
N=4051 enoxaparin (subcutaneous enoxaparin, 40 mg once daily, for 10 +/- 4 days and oral placebo for 35 +/- 4 days).
Primary outcome
Asymptomatic proximal or symptomatic venous thromboembolism at day 10
2.7%
2.7%
2.7 %
2.0 %
1.4 %
0.7 %
0.0 %
Rivaroxaban
Enoxaparin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in asymptomatic proximal or symptomatic VTE at day 10 (2.7% vs. 2.7%; RR 0.97, 95% CI 0.71 to 1.31).
Secondary outcomes
Significant decrease in asymptomatic proximal or symptomatic VTE at 35 days (4.4% vs. 5.7%; RR 0.77, 95% CI 0.62 to 0.96).
Safety outcomes
Significant differences in major or clinically relevant nonmajor bleeding at day 10 (2.8% vs. 1.2%, p < 0.001) and at day 35 (4.1% vs. 1.7%, p < 0.001).
Conclusion
In patients ≥ 40 years of age who were hospitalized for an acute medical illness, rivaroxaban was noninferior to enoxaparin with respect to asymptomatic proximal or symptomatic VTE at day 10.
Reference
Cohen AT, Spiro TE, Buller HR et al. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23.
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