Reduction of Stent Thrombosis in Patients With Acute Coronary Syndrome Treated With Rivaroxaban in ATLAS ACS 2–TIMI 51

Study Questions:

What is the impact of inhibition of thrombin generation via factor Xa inhibition with rivaroxaban on the risk of stent thrombosis?

Methods:

ATLAS ACS 2–TIMI 51 was a placebo-controlled trial that randomly assigned 15,526 patients with a recent acute coronary syndrome (ACS) to receive twice-daily doses of either 2.5 mg or 5 mg of rivaroxaban or placebo for a mean of 13 months and up to 31 months. Hazard ratios with two-sided 95% confidence intervals were used to compare the study groups. Rates of the endpoints were expressed as Kaplan-Meier estimates through 24 months.

Results:

Among subjects who had a stent placed prior to or at the time of the index event, rivaroxaban significantly reduced independently adjudicated Academic Research Consortium (ARC) definite and probable stent thrombosis in the pooled (1.9% vs. 1.5%; HR, 0.65; p = 0.017) and the 2.5 mg BID (1.9% vs. 1.5%; HR, 0.61; p = 0.023) treatment groups when compared to placebo, with a trend toward a reduction in the 5 mg BID treatment group (1.9% vs. 1.5%; HR, 0.70; p = 0.089). Among subjects who received both aspirin and a thienopyridine (stratum 2), the benefit of rivaroxaban emerged during the period of active treatment with dual antiplatelet therapy (DAPT) (HR, 0.68; 95% CI, 0.50-0.92; combined rivaroxaban group vs. placebo). Among stented subjects who were treated with DAPT, there was a mortality reduction among those treated with 2.5 mg BID of rivaroxaban (HR, 0.56; 95% CI, 0.35-0.89; p = 0.014).

Conclusions:

The authors concluded that among stented ACS patients treated with DAPT, the administration of rivaroxaban is associated with a reduction in stent thrombosis and mortality.

Perspective:

This study suggests that rivaroxaban administration is associated with a reduction in stent thrombosis when defined using a variety of ARC definitions. Furthermore, the benefit of rivaroxaban when added to DAPT emerged early and was preserved over time. The results of this analysis highlight the potential additive benefit of inhibiting thrombin generation over DAPT alone among stented patients, but needs to be carefully weighed against the risk of bleeding.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and ACS, Lipid Metabolism, Novel Agents, Interventions and ACS

Keywords: Acute Coronary Syndrome, Kaplan-Meier Estimate, Thrombin, Morpholines, Thrombosis, Thiophenes, Pyridines, Factor Xa, Stents


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