COMPASS Trial
Details
COMPASS established low-dose rivaroxaban plus aspirin as antithrombotic therapy for stable atherosclerotic disease, including symptomatic peripheral artery disease. It compared rivaroxaban 2.5 mg twice daily plus aspirin 81 mg daily with aspirin alone (and with rivaroxaban alone) and was stopped early for benefit. It is the trial behind the COR 1A recommendation for dual-pathway inhibition in PAD. (sources/CCS-AHA-2023, rating: very high) (sources/PVD-AHA-2024, rating: very high)
Key Facts
- Regimen: rivaroxaban 2.5 mg BID + aspirin 81 mg/day versus aspirin alone. (sources/CCS-AHA-2023, rating: very high)
- Efficacy: composite of cardiovascular death, stroke or myocardial infarction 4.1% vs 5.4% with aspirin alone; the trial was terminated early for benefit. (sources/CCS-AHA-2023, rating: very high)
- Bleeding: major bleeding 3.1% vs 1.9% (HR 1.70). (sources/CCS-AHA-2023, rating: very high)
- PAD indication: the regimen is COR 1A for symptomatic PAD to reduce MACE and major adverse limb events (MALE). (sources/PVD-AHA-2024, rating: very high)
- Contraindications: high bleeding risk and prior stroke or intracranial haemorrhage. (sources/PVD-AHA-2024, rating: very high)
- Population: stable PAD — in contrast to VOYAGER PAD, which enrolled patients after revascularisation. (sources/PVD-AHA-2024, rating: very high)
Contradictions / Open Questions
- Efficacy and bleeding move together. The absolute ischaemic benefit is modest and the major-bleeding excess is real (HR 1.70), so net benefit depends on the individual's bleeding risk; the guideline restricts use to patients at low-to-moderate bleeding risk without another indication for anticoagulation. (sources/CCS-AHA-2023, rating: very high)
- The 4.1% vs 5.4% composite is the overall trial result, not a PAD-specific event rate; the PAD subgroup contributed to the benefit, but applying the overall absolute risk reduction to a PAD-only patient overstates the expected gain. (sources/CCS-AHA-2023, rating: very high)
- Whether COMPASS benefits transfer to post-revascularisation patients — and VOYAGER PAD benefits to stable PAD — is not directly tested; the two populations differ in baseline risk. (sources/PVD-AHA-2024, rating: very high)
Connections
- Related to concepts/PAD-Medical-Therapy — dual-pathway inhibition in PAD
- Related to concepts/DAPT-Strategies — low-dose rivaroxaban plus aspirin in chronic coronary disease
- Related to entities/Peripheral-Artery-Disease — the treated population
- Related to entities/VOYAGER-PAD-Trial — the post-revascularisation counterpart