VTE death for rivaroxaban vs enoxaparin 27 vs 27 p for noninferiority 00025 at 35 days 44 vs 57 p 002 Clinically relevant bleeding at 10 days 28 vs 12 at ID: 932464
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MAGELLAN
Primary efficacy endpoint at 10 days (DVT, symptomatic PE,
VTE death
) for rivaroxaban vs. enoxaparin: 2.7% vs. 2.7%, p for noninferiority = 0.0025; at 35 days: 4.4% vs. 5.7%, p = 0.02Clinically relevant bleeding at 10 days: 2.8% vs. 1.2%; at 35 days: 4.1% vs.1.7%, p < 0.0001 for bothAny cardiovascular event: 1.8% vs. 1.6%; all-cause mortality: 5.1% vs. 4.8%; p > 0.05 for both
Trial design: Patients admitted with acute medical conditions were randomized to either subcutaneous enoxaparin 40 mg daily for 10 ± 4 days and oral placebo for 35 ± 4 days, or oral rivaroxaban 10 mg daily for 35 ± 4 days and subcutaneous placebo for 10 ± 4 days. Patients were followed for 90 days.
Results
Conclusions
Presented by Dr. Alexander Cohen at ACC.11/i2 Summit
(p
= 0.0025*)
Rivaroxaban
(n = 3,997)
Primary efficacy endpoint at 10 days
Rivaroxaban
noninferior to enoxaparin at 10 days for efficacy, but superior at 35 days in preventing VTE-related events in acutely ill patients. Tempered by a significant increase in clinically relevant bleedingFurther studies needed to identify subsets that may derive the most benefit with rivaroxaban without a significant increase in bleeding
0
5
10
%
2.7
2.7
%
(p
< 0.0001
)
2.8
1.2
5
Clinically relevant bleeding at 10 days
Enoxaparin(n = 4,001)
0
10
* For
noninferiority