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MAGELLAN: Extended-duration rivaroxaban reduced VTE risk
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New data from the MAGELLAN trial demonstrate that rivaroxaban was noninferior to enoxaparin for standard-duration thromboprophylaxis in acutely ill patients. However, extended-duration rivaroxaban was associated with a reduction in risk for venous thromboembolism.
Researchers studied 8,101 patients aged 40 years or older who were hospitalized for an acute medical illness. Patients were randomly assigned to subcutaneous enoxaparin (Lovenox, Sanofi-Aventis) 40 mg once daily for 10 ± 4 days and oral placebo for 35 ± 4 days or to subcutaneous placebo for 10 ± 4 days and oral rivaroxaban (Xarelto, Janssen Pharmaceuticals)10 mg once daily for 35 ± 4 days.
Alexander T. Cohen
The primary efficacy endpoint was a composite of asymptomatic proximal or symptomatic VTE up to 10 days (noninferiority test) and up to 35 days (superiority test), according to the study abstract.
“We found that for the standard duration of therapy (10 ± 4 days), rivaroxaban was noninferior to enoxaparin. Rivaroxaban administered for an extended duration (35 ± 4 days) was superior to enoxaparin administered for the standard duration followed by placebo,” Alexander T. Cohen, MD, from King’s College Hospital, London, and colleagues wrote in the study.
At day 10, a primary efficacy endpoint event occurred in 2.7% of patients assigned rivaroxaban and 2.7% assigned enoxaparin (RR with rivaroxaban=0.97; 95% CI, 0.71-1.31). At day 35, a primary efficacy endpoint event occurred in 4.4% of patients assigned rivaroxaban and 5.7% assigned enoxaparin followed by placebo (RR=0.77; 95% CI, 0.62-0.96).
The principal safety outcome was clinically relevant bleeding, defined as a composite of major bleeding/clinically relevant non-major bleeding no later than 2 days after the last dose of treatment. A clinically relevant bleeding event occurred in 2.8% of patients assigned rivaroxaban and 1.2% assigned enoxaparin at day 10 (P<.001) and in 4.1% and 1.7%, respectively, at day 35 (P<.001).
“A reduction in the rate of death related to VTE and an increase in the rate of death related to bleeding were seen with extended-duration rivaroxaban prophylaxis,” the researchers wrote. “However, there was no reduction with rivoraxaban in the rate of death from any cause and the incidence was similar in the two groups — findings that were consistent with those in other studies.”
Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.
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