DOAC Monotherapy Bests Dual Antithrombotic Therapy for Afib Plus Coronary Illness

LONDON — For sufferers with atrial fibrillation (Afib) and valid coronary artery disease (CAD), edoxaban (Savaysa) monotherapy improved net outcomes weighing collectively bleeding and ischemic events 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 pressing revascularization, or main bleeding or clinically relevant nonmajor bleeding occurred in 6.8% of sufferers on edoxaban monotherapy and 16.2% assigned to dual antithrombotic therapy (HR 0.44, 95% CI 0.30-0.65, P<0.001).

The adaptation used to be pushed by bleeding, as there used to be no dissimilarity in cumulative incidence of main ischemic events, reported Gi-Byoung Nam, MD, of Asan Clinical Center in Seoul, South Korea, on the European Society of Cardiology (ESC) meeting. The findings were simultaneously published within the Contemporary England Journal of Treatment.

Main bleeding or clinically relevant nonmajor bleeding occurred in 4.7% of the edoxaban monotherapy team and 14.2% of dual antithrombotic therapy handled sufferers (HR 0.34, 95% CI 0.22-0.53).

“This scrutinize is the most important accomplished scrutinize assessing dual versus single antithrombotic therapy completely on a background of an internationally authorized DOAC [direct oral anticoagulant] routine comparable to edoxaban,” well-known ESC session scrutinize discussant Marco Valgimigli, MD, PhD, of the Cardiocentro Ticino Institute in Lugano, Switzerland.

The trial reinforces the ESC and American Heart Affiliation/American College of Cardiology concepts, which suggest oral anticoagulation alone 6-12 months after percutaneous coronary intervention (PCI) or acute coronary syndrome, he talked about, noting that five trials occupy now been accomplished in CAD, with or without PCI, occupy favored single over dual antithrombotic therapy (DAT). The timing of when to transition to a single agent after the early post-occasion length remains unclear, though.

“There might be no such thing as a penalty to pay, apparently, with appreciate to that discontinuation of remedy, whereas the bleeding encourage is extremely clear,” Valgimigli talked about. “So the medical implication of this investigation is that no matter who has, and why used to be, a DAT routine applied, as a clinician within the occasion you in discovering one of these patient you might seemingly quiet also do apart a quiz to your self whether or now no longer that routine is or is now no longer clinically justified.”

On the choice hand, evidence suggests that when it comes time to cease DAT, many sufferers don’t, he well-known.

“It be time to follow the concepts,” he talked about. “I create now no longer deem now we occupy to reinvent the wheel. We need appropriate kind to follow them. And I deem this day with EPIC-CAD, the evidence is stronger than the day gone by.”

Nonetheless, he cautioned that the most important endpoint in EPIC-CAD used to be a posh one to interpret, “seemingly even extra so if that entails revascularization within the atmosphere of a patient population in whom prior revascularization took feature or did no longer happen.”

EPIC-CAD incorporated 1,040 sufferers at 18 net sites in South Korea who had a mark for anticoagulation due to Afib and had valid coronary disease (on the least 6 months post-PCI or 12 months after an acute coronary syndrome, mean 60 months). Of them, 54% had a earlier PCI and the remainder had been managed medically. Contributors’ mean age used to be 72.1, 22.9% were females, and the mean CHA2DS2-VASc get used to be 4.3.

They were randomized to initiate-ticket remedy with popular-dose (60 mg once every single day) edoxaban or dual antithrombotic therapy, which comprised popular-dose edoxaban plus both aspirin or a P2Y12 inhibitor on the treating physician’s discretion.

Nam acknowledged that the trial used to be underpowered for thrombotic events as a sole endpoint.

While absolute charges of bleeding and thrombotic events might differ between Asian and non-Asian sufferers, Valgimigli well-known, decades of research haven’t urged a dissimilarity within the comparative effectiveness of any particular antithrombotic between the two teams.