Combining aspirin with oral anticoagulation in patients with chronic coronary syndrome led to early trial termination following excess deaths in the aspirin group, according to a recent study.
In the multicenter, double-blind, randomized, placebo-controlled AQUATIC trial, researchers enrolled 872 patients at 51 sites in France. Eligible participants had undergone coronary stent implantation at least 6 months prior to enrollment, had chronic coronary syndrome, and were considered at high atherothrombotic risk. The researchers randomly assigned the patients in a 1:1 ratio to receive either 100 mg of aspirin once daily or placebo while continuing their established oral anticoagulant therapy, which included direct oral anticoagulants or vitamin K antagonists. The primary efficacy endpoint combined cardiovascular mortality, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia. The primary safety endpoint was major bleeding defined by International Society on Thrombosis and Haemostasis criteria.
Among the patients receiving long-term oral anticoagulation, adding aspirin increased the risks of cardiovascular mortality, all-cause mortality, and major bleeding without reducing ischemic events, according to results from the trial.
The independent data and safety monitoring board recommended early termination of the trial after a median follow-up of 2.2 years because of an excess of deaths in the aspirin group. A primary efficacy event occurred in 16.9% of patients receiving aspirin compared with 12.1% of those receiving placebo. All-cause mortality occurred in 13.4% vs 8.4% of patients, respectively. Major bleeding occurred in 10.2% of the patients in the aspirin group compared with 3.4% of those in the placebo group. A total of 467 serious adverse events were reported in the aspirin group and 395 in the placebo group.
“Even among high-risk patients with chronic coronary syndrome and a previous stent implantation, our results do not support the use of aspirin added to oral anticoagulation therapy,” noted lead study author Gilles Lemesle, MD, PhD, of the Heart and Lung Institute at the University Hospital of Lille at the Centre Hospitalier Universitaire Lille in France, and colleagues.
The AQUATIC trial was funded by the French Ministry of Health and Bayer Healthcare.