MAGELLAN (VTE Prophylaxis in Medically

Ill Patients)

MAGELLAN (VTE Prophylaxis in Medically Ill Patients)

• A randomized double-blind, double-dummy trial to show noninferiority of rivaroxaban to

enoxaparin at 10 days and superiority at 35 days

• Population and treatment:

8101 patients with ≥1 acute medical condition (infectious disease, HF, respiratory

insufficiency, ischemic stroke, active cancer, or inflammatory/rheumatic diseases)

Randomized to 10 mg rivaroxaban for 35 days or the standard approved dose of enoxaparin

(40 mg by subcutaneous injection for 10 days)

• Primary outcomes:

Primary efficacy outcome: A composite of asymptomatic proximal DVT, symptomatic DVT,

symptomatic nonfatal PE, and VTE-related death

Primary safety outcome: A composite of treatment-related major bleeding and clinically

relevant nonmajor bleeding

A Cohen (King's College, London, UK) American College of Cardiology 2011 Scientific Sessions

DVT=deep vein thrombosis; PE=pulmonary embolism; VTE=venous thromboembolic event

At day 10 At day 35

Rivaroxaban, n=2939

(%)

Enoxaparin, n=2993

(%)

Rivaroxaban, n=2967

(%)

Enoxaparin, n=3057

(%)

Primary composite outcome* 2.7 2.7 4.4 5.7

Asymptomatic proximal DVT 2.4 2.4 3.5 4.4

Symptomatic lower-extremity DVT 0.2 0.2 0.4 0.5

Symptomatic nonfatal PE 0.2 0.1 0.3 0.5

VTE-related death 0.1 0.2 0.6 1.0

Efficacy outcomes at days 10 and 35

• The primary outcome occurred in exactly the same percentage of patients in each

group at day 10 and fewer patients in the rivaroxaban group at day 35

MAGELLAN: Results (efficacy)

*p for noninferiority=0.0025

At day 35: HR=0.77 (95% CI 0.62–0.96); p=0.02

At days 1-10 At days 11-35

Rivaroxaban, n=3997

(%)

Enoxaparin, n=4001

(%)

Rivaroxaban, n=3997

(%)

Enoxaparin, n=4001

(%)

Clinically relevant bleeding* 2.8 1.2 1.4 0.5

Major bleeding 0.6 0.3 0.5 0.1

Fall in hemoglobin >2g/dL 0.4 0.2 0.4 <0.1

Transfusions >2 units blood 0.4 0.1 0.2 <0.1

Critical site bleeding 0.1 0.1 0.1 <0.1

Fatal bleeding 0.1 <0.1 <0.1 0

Bleeding outcomes at days 1–10 and 11–35

• The primary safety outcome was increased with rivaroxaban at days 10 and 35

MAGELLAN: Results (safety)

*A composite of asymptomatic proximal DVT, symptomatic DVT, symptomatic nonfatal PE, VTE-

related death, and treatment-emergent major plus nonmajor clinically relevant bleeding

At days 1-10: HR=2.3; p≤0.0001

At days 11-35: HR=3.0; p≤0.0001

MAGELLAN: Commentary*

*All comments from MAGELLAN: Rivaroxaban prevents VTE in medical patients, but bleeding an

issue (http://www.theheart.org/article/1207331.do)

"This trial included a large range of heterogeneous patients with many different

acute illnesses. We have only just performed this first overall analysis of the data.

We must now go back and look at subgroups to see if there are any groups where

rivaroxaban may be associated with a net clinical benefit."

- Dr Alexander Cohen

"This is an oral drug, and the study shows noninferiority to a subcutaneous drug for

the 10-day period. In some hospitals, the cost and inconvenience of daily injections

might make the oral drug more cost-effective."

- Dr Roy Silverstein

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