Rivaroxaban Plus Aspirin and Mortality in Chronic CAD or PAD

Jun 29, 2021
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Authors:
Eikelboom JW, Bhatt DL, Fox KA, et al.
Citation:
Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol 2021;78:14-23.
Summary By:
Geoffrey D. Barnes, MD, MSc, FACC

Quick Takes

  • Combination rivaroxaban plus aspirin reduced all-cause and cardiovascular mortality as compared to aspirin alone for patients with stable CAD and/or PAD.
  • Patients with stable CAD and/or PAD plus baseline high-risk features experienced greater mortality benefit with rivaroxaban plus aspirin therapy.

Study Questions:

What is the effect of combination rivaroxaban plus aspirin on overall and cause-specific mortality for patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)?

Methods:

In the COMPASS trial, 18,278 patients were randomized to combination therapy (n = 9,152) or aspirin alone (n = 9,126). Deaths were adjudicated by a blinded committee. Enrolled patients had high-risk baseline features including polyvascular disease, chronic kidney disease, mild or moderate heart failure, and/or diabetes.

Results:

Over a median follow-up of 23 months, 313 patients (3.4%) who received combination therapy and 378 patients (4.1%) who received aspirin alone died (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.71-0.96). Compared to aspirin alone, combination therapy reduced cardiovascular death (1.7% vs. 2.2%; HR, 0.78; 95% CI, 0.64-0.96) but not noncardiovascular death. Patients with 0, 1, 2, and 3/4 high-risk features at baseline had 4.2, 4.8, 25.0, and 53.9 fewer deaths, respectively, per 1,000 patients treated for 30 months.

Conclusions:

The authors concluded that combination of rivaroxaban plus aspirin compared to aspirin alone reduced overall and cardiovascular mortality for patients with chronic CAD or PAD. They also concluded that mortality benefits are greater for patients with increasing baseline risk.

Perspective:

This prespecified analysis of the COMPASS trial explored key mortality outcomes for patients with chronic CAD and/or PAD randomized to rivaroxaban 2.5 mg twice daily plus aspirin 81 mg daily or aspirin 81 mg daily alone. The combination therapy reduced both all-cause mortality as well as cardiovascular-specific mortality. Most importantly, the overall mortality benefit increased as the number of baseline high-risk features (polyvascular disease, chronic kidney disease, heart failure, diabetes) increased. In fact, for patients with three or four high-risk features, the number needed to treat was only 19 to prevent one death. These findings complement other analyses of the COMPASS trial and real-world registries that suggest benefit of combination rivaroxaban plus aspirin therapy for patients with chronic CAD/PAD plus one or more high-risk features.

Clinical Topics: Anticoagulation Management, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Acute Heart Failure

Keywords: Anticoagulants, Aspirin, Coronary Artery Disease, Diabetes Mellitus, Heart Failure, Peripheral Arterial Disease, Geriatrics, Myocardial Ischemia, Primary Prevention, Renal Insufficiency, Chronic, Vascular Diseases


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