American College of Cardiology Foundation

07/15/2019 | Press release | Distributed by Public on 07/15/2019 16:14

Rivaroxaban in PAD

The following are key points to remember about rivaroxaban in the management of peripheral artery disease (PAD):

  1. Management guidelines for PAD currently include surgery, antiplatelet agents, and statins.
  2. An additional pharmacologic option for managing PAD could prove beneficial given the high rate of major adverse limb events (MALEs) in these patients.
  3. A total of 6,391 patients in the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial met criteria for the stable PAD cohort and was included in the secondary analysis. The overall COMPASS trial included 27,395 patients with coronary artery disease (CAD) and/or PAD. Patients who required dual antiplatelet therapy, anticoagulation, or other non-aspirin antiplatelet therapy were excluded from the study.
  4. All patients were randomized to rivaroxaban 2.5 mg twice daily with aspirin 100 mg daily, rivaroxaban 5 mg twice daily, or aspirin 100 mg once daily.
  5. Study outcomes included 1) rates of death, amputation, major adverse cardiovascular event (MACE), and hospitalization after MALE compared with rates in patients without MALE and 2) rates of MALE, peripheral vascular intervention, and all peripheral vascular outcomes in patients treated with rivaroxaban plus aspirin versus aspirin monotherapy.
  6. Results showed the following:
    • By 1 year following index episode of MALE, patients experienced increased incidence of death (8.3%), amputation (20.5%), MACE (3.7%), and/or hospitalization (61.5%).
    • In patients treated with rivaroxaban plus aspirin versus aspirin alone, rate of MALE was 1.5% versus 2.6% (33% reduction in the relative risk; statistically significant), rate of peripheral vascular intervention was 5.5% versus 7.1%, (24% reduction in the relative risk), and incidence of all peripheral vascular outcomes was reduced by 24%.
  7. Rivaroxaban plus aspirin decreased incidence of MALE by 43%, amputations by 58%, peripheral vascular interventions by 24%, and all peripheral vascular outcomes by 24%. All were statistically significant.
  8. Safety outcomes in the overall COMPASS trial showed more major bleeding events in patients treated with rivaroxaban plus aspirin versus aspirin alone (3.1% vs. 1.9%; p < .001). In patients with PAD, the overall incidence of bleeding complications was 2.7%.
  9. The authors state the secondary analysis of the COMPASS trial suggests rivaroxaban 2.5 mg twice daily in conjunction with aspirin 100 mg daily might represent a new and effective treatment for PAD.
  10. Based on results of the COMPASS trial, the US Food and Drug Administration approved a new indication for rivaroxaban, in conjunction with aspirin, for reducing risk of MACE (cardiovascular death, myocardial infarction, and stroke) in patients with coronary artery disease and PAD in October 2018.

Clinical Topics:Anticoagulation Management, Vascular Medicine, Atherosclerotic Disease (CAD/PAD)

Keywords:Peripheral Arterial Disease, Aspirin, Platelet Aggregation Inhibitors, Factor Xa Inhibitors, Hydroxymethylglutaryl CoA Reductases, Coronary Artery Disease


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