Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation.
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