Potent antiplatelet remedy elevated bleeding with out indicators of profit concerning cardiovascular occasions in sufferers with atrial fibrillation after a coronary heart assault. This was the primary discovering of the EPIDAURUS trial offered in a Scorching Line session right this moment at ESC Congress 2026 and revealed concurrently in Nature Medication.
Atrial fibrillation (AF) impacts virtually 38 million individuals worldwide, with the prevalence predicted to double over the subsequent 35 years. Principal Investigator, Professor Konstantinos Rizas from the Ludwig Maximilians College, Munich, Germany and the Cantonal Hospital St. Gallen, Switzerland, defined that the EPIDAURAS trial was carried out to fill an necessary hole in scientific information: “Many sufferers who’ve AF obtain direct oral anticoagulants to scale back their danger of stroke. Sufferers who’ve lately had a myocardial infarction (MI) obtain antiplatelet remedy, particularly the mix of aspirin and a potent P2Y12 inhibitor, to scale back their danger of one other ischemic occasion. However the optimum routine for sufferers affected by each AF and MI stays unclear.” He famous that there’s little proof on the usage of the potent P2Y12 inhibitors, prasugrel or ticagrelor, together with direct oral anticoagulants in these sufferers.
The EPIDAURUS trial in contrast a one-month routine of a direct oral anticoagulant plus prasugrel or ticagrelor (experimental group) vs. a direct oral anticoagulant plus clopidogrel with in-hospital aspirin (management group). The direct oral anticoagulants, edoxaban, apixaban and rivaroxaban had been permitted within the trial. Eligible sufferers had a sign for oral anticoagulation due to AF and had had an MI inside 5 days of randomisation. The trial was carried out at 37 websites in Germany and Austria.
The research was prematurely terminated after enrolment of 602 of the deliberate 1,474 sufferers as a result of security considerations raised by the Information and Security Monitoring Board.
Within the six weeks after randomization, the experimental group had larger charges of all secondary bleeding endpoints than the management group. The incidence of great bleeding was greater than threefold larger within the experimental group in contrast with the management group (Bleeding Tutorial Analysis Consortium 3 or extra: hazard ratio 3.54; 95% confidence interval 1.15 to 10.85; p=0.028).
There was no distinction between the teams for all major and secondary efficacy endpoints at six weeks and 6 months when the impact of remedy was examined for numerous ischemic outcomes, akin to cardiovascular dying, MI and stroke.
Within the first trial of its variety, we have now answered an necessary scientific query. These findings don’t help the routine use of potent P2Y12 inhibitors together with direct oral anticoagulants in sufferers with AF and MI.”
Professor Konstantinos Rizas, Ludwig Maximilians College, Munich, Germany
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