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Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation
Gilles Lemesle1,2,3,4, Romain Didier5,6,7, Philippe Gabriel Steg4,8,9,10
1Heart and Lung Institute, University Hospital of Lille, Centre Hospitalier Universitaire (CHU) Lille, Lille, France.
Insights
Adding aspirin to oral anticoagulation for high-risk chronic coronary syndrome patients increased risks of death and major bleeding. This combination therapy is not recommended due to safety concerns.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Optimal antithrombotic strategy for chronic coronary syndrome (CCS) patients with high atherothrombotic risk on long-term oral anticoagulation (OAC) is undefined.
- Previous stent implantation is common in this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of adding aspirin to OAC in high-risk CCS patients.
- To determine the optimal antithrombotic regimen for this specific patient group.
Main Methods:
- A multicenter, double-blind, randomized, placebo-controlled trial was conducted.
- 872 patients with CCS, prior stent implantation, high atherothrombotic risk, and on long-term OAC were randomized (1:1) to aspirin (100 mg/day) or placebo, continuing OAC.
- Primary efficacy outcome: composite of cardiovascular death, MI, stroke, embolism, revascularization, or acute limb ischemia. Key safety outcome: major bleeding.
Main Results:
- The trial was stopped early due to excess all-cause mortality in the aspirin group.
- A primary efficacy outcome event occurred more frequently in the aspirin group (16.9%) vs. placebo (12.1%).
- All-cause mortality (13.4% vs. 8.4%) and major bleeding (10.2% vs. 3.4%) were significantly higher with aspirin addition.
Conclusions:
- Adding aspirin to OAC in high-risk CCS patients significantly increased risks of major adverse cardiovascular events, all-cause death, and major bleeding.
- The findings suggest that aspirin should not be added to OAC in this patient population due to unfavorable risk-benefit profile.
- Further research may be needed to explore alternative antithrombotic strategies.
Background:
The appropriate antithrombotic regimen for patients with chronic coronary syndrome who are at high atherothrombotic risk and receiving long-term oral anticoagulation remains unknown.
Methods:
We conducted a multicenter, double-blind, randomized, placebo-controlled trial in France involving patients with chronic coronary syndrome who had undergone a previous stent implantation (>6 months before enrollment) and were at high atherothrombotic risk and currently receiving long-term oral anticoagulation. The patients were randomly assigned in a 1:1 ratio to receive aspirin (100 mg once daily) or placebo; all the patients continued to receive their current oral anticoagulation therapy. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia. The key safety outcome was major bleeding.
Results:
A total of 872 patients underwent randomization; 433 were assigned to the aspirin group, and 439 to the placebo group. The trial was stopped early at the advice of the independent data and safety monitoring board after a median follow-up of 2.2 years because of an excess of deaths from any cause in the aspirin group. A primary efficacy outcome event occurred in 73 patients (16.9%) in the aspirin group and in 53 patients (12.1%) in the placebo group (adjusted hazard ratio, 1.53; 95% confidence interval [CI], 1.07 to 2.18; P = 0.02). Death from any cause occurred in 58 patients (13.4%) in the aspirin group and in 37 (8.4%) in the placebo group (adjusted hazard ratio, 1.72; 95% CI, 1.14 to 2.58; P = 0.01). Major bleeding occurred in 44 patients (10.2%) in the aspirin group and in 15 patients (3.4%) in the placebo group (adjusted hazard ratio, 3.35; 95% CI, 1.87 to 6.00; P<0.001). A total of 467 and 395 serious adverse events were reported in the aspirin group and placebo group, respectively.
Conclusions:
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. (Funded by the French Ministry of Health and Bayer Healthcare; ClinicalTrials.gov number, NCT04217447.).
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