Rivaroxaban in Patients with a Recent Acute Coronary Syndrome

Rivaroxaban in Patients with a Recent Acute Coronary Syndrome

JANUARY 5, 2012 VOL. 366 NO. 1 | Jessica L. Mega, M.D., M.P.H., Eugene Braunwald, M.D., Stephen D. Wiviott, M.D., Jean-Pierre Bassand, M.D., Deepak L. Bhatt, M.D., M.P.H., Christoph Bode, M.D., Paul Burton, M.D., Ph.D., Marc Cohen, M.D., Nancy Cook-Bruns, M.D., Keith A.A. Fox, M.B., Ch.B., Shinya Goto, M.D., Sabina A. Murphy, M.P.H., Alexei N. Plotnikov, M.D., David Schneider, M.D., Xiang Sun, Ph.D., Freek W.A. Verheugt, M.D., and C. Michael Gibson, M.D., for the ATLAS ACS 2–TIMI 51 Investigators*
This study evaluated the efficacy and safety of rivaroxaban in patients with a recent acute coronary syndrome (ACS). The ATLAS ACS 2–TIMI 51 trial was a double-blind, placebo-controlled, event-driven trial that included 15,526 patients randomized to receive either 2.5 mg or 5 mg of rivaroxaban twice daily or placebo for up to 31 months. The primary efficacy endpoint was a composite of death from cardiovascular causes, myocardial infarction, or stroke. Rivaroxaban significantly reduced the primary efficacy endpoint compared to placebo (hazard ratio, 0.84; 95% CI, 0.74 to 0.96; P=0.008), with a significant benefit seen in both the 2.5 mg and 5 mg doses. The 2.5 mg dose also reduced the risk of death from cardiovascular causes (hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P=0.002) and any cause (hazard ratio, 0.68; 95% CI, 0.53 to 0.87; P=0.002). However, rivaroxaban increased the rate of major bleeding not related to coronary artery bypass grafting (TIMI major bleeding) compared to placebo (hazard ratio, 3.96; 95% CI, 2.46 to 6.38; P<0.001), but this increase was not significant for fatal bleeding. The lower dose of rivaroxaban resulted in less bleeding than the higher dose. The study concluded that rivaroxaban reduced the risk of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, with a beneficial effect observed regardless of the type of ACS presentation.This study evaluated the efficacy and safety of rivaroxaban in patients with a recent acute coronary syndrome (ACS). The ATLAS ACS 2–TIMI 51 trial was a double-blind, placebo-controlled, event-driven trial that included 15,526 patients randomized to receive either 2.5 mg or 5 mg of rivaroxaban twice daily or placebo for up to 31 months. The primary efficacy endpoint was a composite of death from cardiovascular causes, myocardial infarction, or stroke. Rivaroxaban significantly reduced the primary efficacy endpoint compared to placebo (hazard ratio, 0.84; 95% CI, 0.74 to 0.96; P=0.008), with a significant benefit seen in both the 2.5 mg and 5 mg doses. The 2.5 mg dose also reduced the risk of death from cardiovascular causes (hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P=0.002) and any cause (hazard ratio, 0.68; 95% CI, 0.53 to 0.87; P=0.002). However, rivaroxaban increased the rate of major bleeding not related to coronary artery bypass grafting (TIMI major bleeding) compared to placebo (hazard ratio, 3.96; 95% CI, 2.46 to 6.38; P<0.001), but this increase was not significant for fatal bleeding. The lower dose of rivaroxaban resulted in less bleeding than the higher dose. The study concluded that rivaroxaban reduced the risk of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, with a beneficial effect observed regardless of the type of ACS presentation.
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