Coronary disease & ACSRandomised controlled trial

Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation

N Engl J MedPublished

  • Randomised controlled trial
  • multicentre
  • double-blind
  • placebo-controlled
  • stopped early
  • Stopped early at the advice of the independent data and safety monitoring board after a median follow-up of 2.2 years

Authors' conclusion

Among patients with chronic coronary syndrome at high atherothrombotic risk who were receiving an oral anticoagulant, the addition of aspirin led to a higher risk of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia than placebo, as well as higher risks of death from any cause and major bleeding.

Study context

Population
Patients in France with chronic coronary syndrome, previous stent (>6 months before enrollment), high atherothrombotic risk, on long-term OAC
Participants
872 patients
Comparison
Aspirin vs placebo on top of OAC
  • Aspirinn = 433
  • Placebon = 439reference
Primary endpoint
Composite of:
  • CV death
  • MI
  • Stroke
  • Systemic embolism
  • Coronary revascularization
  • Acute limb ischemia
Follow-up
Median 2.2 years

Primary result

As reported in the abstract

Adjusted hazard ratio

1.53

95% CI 1.07–2.18

P = 0.02

Events by treatment group

Aspirin vs Placebo
adjusted HR 1.53 (95% CI 1.07–2.18); P = 0.02

Further findings

OutcomeAspirinPlaceboadjusted HR (95% CI)P value
All-cause death13.4%8.4%1.72 (1.14–2.58)P = 0.01

Safety

OutcomeAspirinPlaceboadjusted HR (95% CI)P value
Major bleeding (key safety outcome)10.2%3.4%3.35 (1.87–6.00)P < 0.001

events

OutcomeAspirinPlaceboEstimateP value
Serious adverse events (number reported)467395

Original publication

Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation. N Engl J Med. Published 31 August 2025. doi:10.1056/nejmoa2507532

Summarised from the published abstract; every number is checked against it