ESC Congress 2025 | AQUATIC: As part of the Hot Line Session 6 on August 31, Prof Louise Bowman presented the AQUATIC trial about the assessment of therapy patients with stabilized coronary artery disease after stenting who require long-term oral anticoagulation. In the interview, she explains the design and findings of the double-blind randomized trial.
(Duration: 6.50 minutes)
By:
Romy Martínez
HERZMEDIZIN editorial team
2025-09-08
Image source (image above): Songquan Deng / Shutterstock.com
The randomised trial was conducted at 51 centres in France. Eligible patients had CCS and stent implantation (>6 months before), were at high atherothrombotic risk and required long-term OAC for any reason (mainly AF). Patients were randomised 1:1 to aspirin or placebo on top of OAC (either a direct OAC or vitamin K antagonists).
The trial was stopped early on the advice of the independent Data Safety Monitoring Board after a median follow-up of 2.2 years due to an excess of all-cause mortality in the aspirin group. The 872 patients randomised had a mean age of 72 years and 14.5% were male. The primary efficacy outcome occurred in significantly more patients in the aspirin group than the placebo group (16.9% vs. 12.1%; adjusted HR 1.53; 95%CI 1.07 to 2.18; p=0.019). All-cause death also occurred in significantly more patients with aspirin vs. placebo (13.4% vs. 8.4%; adjusted HR 1.72; 95% CI 1.14 to 2.58; p=0.010). The risk of major bleeding was more than three-fold higher in the aspirin group than the placebo group (10.2% vs. 3.4%; HR 3.35; 95% CI 1.87 to 6.00; p<0.0001). A total of 467 and 395 serious adverse events were reported in the aspirin and placebo groups, respectively.
Conclusion: Among patients with CCS at high atherothrombotic risk who require OAC therapy, aspirin significantly increased the risk of major cardiovascular events, allcause mortality and major bleeding, and its use should be discouraged.
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