April 19, 2013
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Rivaroxaban reduced stent thrombosis, mortality rates in ACS patients

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New results from the ATLAS ACS 2-TIMI 51 trial show that giving 2.5 mg twice-daily rivaroxaban can reduce the rates of stent thrombosis and mortality among stented patients with ACS who are treated with dual antiplatelet therapy.

C. Michael Gibson, MD, with Beth Israel Deaconess Medical Center, Harvard Medical School, and investigators of the placebo-controlled ATLAS ACS 2-TIMI 51 trial randomly assigned 15,526 patients with a recent ACS to 2.5 mg or 5 mg rivaroxaban (Xarelto, Janssen Pharmaceuticals) twice daily or placebo for a mean of 13 months and up to 31 months.

Rivaroxaban significantly reduced definite and probable stent thrombosis in the pooled (1.5% vs. 1.9%; HR=0.65; P=.017) and 2.5 mg twice-daily (1.5% vs. 1.9%; HR=0.61; P=.023) treatment groups when compared with placebo among those who had a stent placed before or at the time of the index event. There was a trend toward a reduction in the 5 mg twice-daily treatment group (1.5% vs. 1.9%; HR=0.70; P=.089).

The combined rivaroxaban group offered a benefit during the period of active treatment with DAPT compared with placebo (HR=0.68; 95% CI, 0.50-0.92) among those who received aspirin and a thienopyridine.

Among stented patients who were treated with DAPT, there was a mortality reduction among those treated with 2.5 mg twice-daily rivaroxaban (HR=0.56; 95% CI, 0.35-0.89).

 

C. Michael Gibson

“It is not known whether the observed reduction in stent thrombosis in this study is mediated by a reduction in thrombin generation, which in turn directly mediates stent thrombosis, or alternatively, if the reduction in stent thrombosis is mediated by a reduction in the stimulation of platelet aggregation in so far as thrombin is a potent stimulant of platelets,” Gibson and colleagues wrote.

Disclosure: Gibson reports receiving grants from Abbott, Bayer, Genentech, Ikaria, Johnson & Johnson, Merck and Sanofi-Aventis; honoraria for consulting from Biogen IDEC, Bristol-Myers Squibb, CSL Behring, Cytori Therapeutics, Daiichi Sankyo, Eli Lilly, Genentech, GlaxoSmithKline, Ischemix, Medicure, Merck, Portola, Regado, Sanofi-Aventis and The Medicines Company; and compensation for lectures/service on speakers’ bureaus for Daiichi Sankyo and Eli Lilly. The trial was supported by Johnson & Johnson and Bayer Healthcare.