Posted by Carla Rothaus
In the trial by Bonaca et al., did rivaroxaban plus aspirin, as compared to placebo plus aspirin, reduce the risk of ischemic events?
Patients who undergo peripheral revascularization are at high risk for subsequent vascular complications and particularly for acute limb ischemia. Bonaca et al. conducted a double-blind trial that compared outcomes with rivaroxaban at a dose of 2.5 mg twice daily plus aspirin versus aspirin alone in patients with symptomatic peripheral artery disease who had undergone lower-extremity revascularization. Read the NEJM Original Article here.
Q: Should peripheral artery disease be understood as essentially the same disease process as coronary artery disease and cerebrovascular disease?
A: Although the underlying disease state of atherosclerosis is shared with coronary artery disease and cerebrovascular disease, it is increasingly clear that peripheral artery disease represents a distinct disorder characterized by a high risk of adverse events affecting the limbs, including acute limb ischemia and major amputation, as well as major adverse cardiovascular events.
Q: What therapy is currently recommended for patients with symptomatic peripheral artery disease?
A: Current practice guidelines recommend aspirin or clopidogrel monotherapy for patients with symptomatic peripheral artery disease, regardless of the clinical setting. Although the use of dual antiplatelet therapy is common after revascularization for peripheral artery disease, data to support this practice are either observational or extrapolated from randomized trials involving patients with coronary artery disease, in which efficacy has been shown for cardiovascular risk and coronary stent thrombosis rather than for limb outcomes.
Morning Report Questions
Q: In the trial by Bonaca et al., did rivaroxaban plus aspirin, as compared to placebo plus aspirin, reduce the risk of ischemic events?
A: In this trial, which involved a broad population of patients who had undergone lower-extremity revascularization, nearly 1 in 5 patients in the placebo group had the primary composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes at 3 years. The addition of rivaroxaban at a dose of 2.5 mg twice daily to aspirin reduced this risk by approximately 15%. The primary composite outcome occurred in 508 patients in the rivaroxaban group and in 584 patients in the placebo group; the Kaplan–Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85; 95% confidence interval, 0.76 to 0.96; P=0.009). The benefit was apparent early, with the Kaplan–Meier curves separating at 3 months, was consistent among subgroups, and continued to accrue over time.
Q: How did the incidence of bleeding compare in the two groups in the trial by Bonaca et al.?
A: There was no significant difference in the incidence of TIMI major bleeding (fatal bleeding, intracranial hemorrhage, a decrease in hemoglobin level of ≥5 g per deciliter, or a decrease in hematocrit of ≥15%) between the groups. However, there was a significantly higher incidence of the secondary safety outcome of ISTH major bleeding (fatal bleeding, bleeding into a critical site, a decrease in hemoglobin level of ≥2 g per deciliter, or transfusion of at least 2 units of packed red cells or whole blood) in the rivaroxaban group.
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