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Evevident
Original paper
2017NEJMCardiology

COMPASS

Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

RCTChronic CAD/PAD antithrombotic therapy

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Overview

In stable CAD/PAD, vascular-dose rivaroxaban plus aspirin reduced CV death, stroke, or MI but increased major bleeding.

Clinical takeaway

COMPASS supports dual-pathway inhibition for selected high-risk stable atherosclerotic disease patients with acceptable bleeding risk. The benefit was with rivaroxaban 2.5 mg twice daily plus aspirin, not full-dose rivaroxaban monotherapy.

Key result

Primary outcome: 4.1% with rivaroxaban plus aspirin vs 5.4% with aspirin alone; HR 0.76.

Practice impact

Use vascular-dose rivaroxaban plus aspirin selectively in stable CAD/PAD patients with high ischemic risk and low bleeding risk.

Evidence

Study design

Randomized, double-blind, placebo-controlled trial.

Enrollment

27,395

Follow-up

Mean 23 months; trial stopped early for superiority.

Geography

Multinational

Clinical question

Does adding low-dose rivaroxaban to aspirin improve outcomes in stable atherosclerotic vascular disease?

Population

  • Patients with stable coronary artery disease, peripheral artery disease, or both.

Intervention

Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily.

Comparator

Aspirin 100 mg daily alone.

Primary outcome

Composite of cardiovascular death, stroke, or myocardial infarction.

Rivaroxaban 2.5 mg twice daily plus aspirin reduced cardiovascular death, stroke, or MI compared with aspirin alone.

Hazard ratio / 0.76 / CI 95% CI 0.66-0.86 / p=<0.001

Key results

  • Primary outcome: 4.1% with rivaroxaban plus aspirin vs 5.4% with aspirin alone; HR 0.76; 95% CI 0.66-0.86; p<0.001.
  • Major bleeding: 3.1% vs 1.9%; HR 1.70; 95% CI 1.40-2.05; p<0.001.
  • Rivaroxaban 5 mg twice daily alone did not significantly improve cardiovascular outcomes and increased major bleeding.

Harms

  • Major bleeding was increased with rivaroxaban plus aspirin.
  • No significant excess in intracranial or fatal bleeding was reported versus aspirin alone.

Clinical Use

When to cite

  • When considering rivaroxaban 2.5 mg twice daily plus aspirin in chronic CAD or PAD.

Practice impact

  • Provides outcomes evidence for dual-pathway inhibition in selected stable CAD/PAD patients.

Applicability

  • Most applicable to stable CAD/PAD patients at high ischemic risk who do not need therapeutic anticoagulation or DAPT and have acceptable bleeding risk.

Limitations

  • Higher major bleeding risk requires careful patient selection.
  • Excluded patients who needed oral anticoagulation or dual antiplatelet therapy.
  • Net benefit depends on baseline ischemic and bleeding risk.

Common misinterpretations

  • Do not use COMPASS to justify full-dose rivaroxaban monotherapy for stable CAD/PAD event prevention.

Related evidence

VOYAGER PAD - Same Drug ClassCURE - ContextPLATO - Context

Citation

Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017;377(14):1319-1330. doi:10.1056/NEJMoa1709118

Rivaroxaban plus aspirin had better cardiovascular outcomes and more major bleeding events.