130 likes | 610 Views
ATLAS ACS-TIMI 46. No difference between rivaroxaban and placebo in the primary outcome (death, MI, stroke, severe ischemia) ( HR 0.79, 95% CI 0.60-1.05) ↓ in death, MI, stroke with rivaroxaban
E N D
ATLAS ACS-TIMI 46 No difference between rivaroxaban and placebo in the primary outcome (death, MI, stroke, severe ischemia) (HR 0.79, 95% CI 0.60-1.05) ↓ in death, MI, stroke with rivaroxaban Dose-response curve for bleeding with rivaroxaban, especially in the setting of dual antiplatelet therapy (p < 0.001) (p = 0.10) (p = 0.028) Placebo (n = 1,160) Rivaroxaban (n = 1,166) Trial design: Patients with ACS were randomized to either rivaroxaban twice daily, once daily, or placebo. Clinical outcomes were compared at 6 months. Results 20 20 15 15 % % 10 10 7.0 Conclusions 5.6 5.5 • Rivaroxaban has reasonable efficacy compared with placebo in patients with ACS, with a higher bleeding risk • This was a phase II clinical trial conducted to identify safe and effective doses of rivaroxaban to be used in the phase III trial 5 3.9 5 0 0 Primary outcome Death/MI/Stroke Mega JL, et al. Lancet 2009;Jun 17:Epub