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Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation.

The New England journal of medicine2025-09-01PubMed
Total: 88.5Innovation: 8Impact: 0Rigor: 0Citation: 0

Summary

In a multicenter, double-blind RCT of 872 chronic coronary syndrome patients already on long-term oral anticoagulation, adding daily aspirin increased the composite of cardiovascular events, all-cause mortality, and major bleeding versus placebo, prompting early trial termination. Results argue against routine aspirin on top of oral anticoagulation in this high-risk group.

Key Findings

  • Primary composite endpoint occurred in 16.9% with aspirin vs 12.1% with placebo (adjusted HR 1.53).
  • All-cause mortality was higher with aspirin: 13.4% vs 8.4% (adjusted HR 1.72).
  • Major bleeding tripled with aspirin: 10.2% vs 3.4% (adjusted HR 3.35); trial stopped early for excess deaths.

Clinical Implications

Avoid routine aspirin addition to oral anticoagulation in chronic coronary syndrome with prior stenting and high atherothrombotic risk; prioritize OAC monotherapy unless a compelling short-term indication exists, and re-evaluate bleeding risk regularly.

Why It Matters

This double-blind RCT provides definitive evidence that aspirin on top of oral anticoagulation harms high-risk CCS patients, challenging common additive strategies and informing guideline updates.

Limitations

  • Early termination may inflate effect estimates and limits long-term assessment
  • Conducted in France; generalizability to other health systems requires caution

Future Directions

Define subgroups (e.g., recent stenting, complex PCI) where short-term aspirin may still be warranted; evaluate alternative strategies (e.g., OAC plus P2Y12 inhibitor) and personalized bleeding/ischemia risk tools.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
I - Randomized, double-blind, placebo-controlled clinical trial with hard outcomes
Study Design
OTHER