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LONDON -- For patients with atrial fibrillation (Afib) and stable coronary artery disease (CAD), edoxaban (Savaysa) monotherapy improved net outcomes weighing together bleeding and ischemic events as compared with dual antithrombotic therapy, the EPIC-CAD trial showed.

The 12-month composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding occurred in 6.8% of patients on edoxaban monotherapy and 16.2% assigned to dual antithrombotic therapy (HR 0.44, 95% CI 0.30-0.65, P<0.001).

The difference was driven by bleeding, as there was no difference in cumulative incidence of major ischemic events, reported Gi-Byoung Nam, MD, of Asan Medical Center in Seoul, South Korea, at the European Society of Cardiology (ESC) meeting. The findings were simultaneously published in the .

Major bleeding or clinically relevant nonmajor bleeding occurred in 4.7% of the edoxaban monotherapy group and 14.2% of dual antithrombotic therapy treated patients (HR 0.34, 95% CI 0.22-0.53).

"This study is the first completed study assessing dual versus single antithrombotic therapy exclusively on a background of an internationally approved DOAC [direct oral anticoagulant] regimen such as edoxaban," noted ESC session study discussant Marco Valgimigli, MD, PhD, of the Cardiocentro Ticino Institute in Lugano, Switzerland.

The trial reinforces the ESC and American Heart Association/American College of Cardiology guidelines, which recommend oral anticoagulation alone 6-12 months after percutaneous coronary intervention (PCI) or acute coronary syndrome, he said, noting that five trials have now been done in CAD, with or without PCI, have favored single over dual antithrombotic therapy (DAT). The timing of when to transition to a single agent after the early post-event period remains unclear, though.

"There is no penalty to pay, apparently, with respect to that discontinuation of treatment, whereas the bleeding benefit is very clear," Valgimigli said. "So the clinical implication of this investigation is that irrespective of who has, and why was, a DAT regimen implemented, as a clinician when you encounter such a patient you should also ask yourself whether that regimen is or is not clinically justified."

However, evidence suggests that when it comes time to discontinue DAT, many patients don't, he noted.

"It's time to follow the guidelines," he said. "I don't think we have to reinvent the wheel. We need just to follow them. And I think today with EPIC-CAD, the evidence is stronger than yesterday."

Nevertheless, he cautioned that the primary endpoint in EPIC-CAD was a difficult one to interpret, "perhaps even more so if that includes revascularization in the setting of a patient population in whom prior revascularization took place or did not occur."

EPIC-CAD included 1,040 patients at 18 sites in South Korea who had an indication for anticoagulation due to Afib and had stable coronary disease (at least 6 months post-PCI or 12 months after an acute coronary syndrome, mean 60 months). Of them, 54% had a prior PCI and the rest had been managed medically. Participants' mean age was 72.1, 22.9% were women, and the mean CHA2DS2-VASc score was 4.3.

They were randomized to open-label treatment with standard-dose (60 mg once daily) edoxaban or dual antithrombotic therapy, which comprised standard-dose edoxaban plus either aspirin or a P2Y12 inhibitor at the treating physician's discretion.

Nam acknowledged that the trial was underpowered for thrombotic events as a sole endpoint.

While absolute rates of bleeding and thrombotic events may differ between Asian and non-Asian patients, Valgimigli noted, decades of research haven't suggested a difference in the comparative effectiveness of any specific antithrombotic between the two groups.

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