MAGELLAN Trial design Patients admitted with acute medical

MAGELLAN 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 (p = 0. 0025*) (p < 0. 0001) 10 10 • 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. 02 • Clinically relevant bleeding at 10 days: 2. 8% vs. 1. 2%; at 35 days: 4. 1% vs. 1. 7%, p < 0. 0001 for both % % 5 • Any cardiovascular event: 1. 8% vs. 1. 6%; all-cause mortality: 5. 1% vs. 4. 8%; p > 0. 05 for both 5 2. 8 2. 7 1. 2 0 0 Primary efficacy endpoint at 10 days Clinically relevant bleeding at 10 days * For noninferiority Rivaroxaban (n = 3, 997) Enoxaparin (n = 4, 001) Conclusions • Rivaroxaban noninferior to enoxaparin at 10 days for efficacy, but superior at 35 days in preventing VTErelated events in acutely ill patients. Tempered by a significant increase in clinically relevant bleeding • Further studies needed to identify subsets that may derive the most benefit with rivaroxaban without a significant increase in bleeding Presented by Dr. Alexander Cohen at ACC. 11/i 2 Summit