Edoxaban reduced clinical events with less bleeding vs. dual therapy for AF, stable CAD
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Key takeaways:
- Single antiplatelet therapy with edoxaban reduced bleeding risk in patients with AF and stable CAD vs. dual therapy.
- Incidence of death, MI and stroke and other events were similarly low between the two groups.
Edoxaban monotherapy for patients with atrial fibrillation and stable coronary disease reduced risk for adverse clinical events, mainly driven by lower bleeding risk, compared with dual antiplatelet therapy, a speaker reported.
The results of the EPIC-CAD trial conducted in South Korea were presented at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine.
Duk-Woo Park, MD, PhD, interventional cardiologist at Asan Medical Center, University of Ulsan College of Medicine in Seoul, South Korea, said during a press conference that despite having randomized trial-backed guidance on antiplatelet therapy after ACS or PCI in patients with AF, there is a paucity of data on optimal strategies for patients with AF and stable CAD, so the EPIC-CAD trial was designed to address this unmet need.
For the EPIC-CAD trial, researchers enrolled 1,038 patients with AF, a CHA2DS2-VASc score of 2 or higher and stable CAD and randomly assigned them to edoxaban monotherapy (Savaysa, Daiichi Sankyo) or dual therapy with edoxaban and a single antiplatelet agent (mean age, 72 years; 23% women; mean CHA2DS2-VASc score, 4.3).
The primary outcome was net adverse clinical events including all-cause death, stroke, systemic embolic events, MI, urgent revascularization and major or clinically relevant nonmajor bleeding (as defined by the International Society on Thrombosis and Haemostasis) at 1 year.
Overall, the primary outcome of net adverse clinical events occurred in 6.8% of the edoxaban monotherapy arm compared with 16.2% of the dual therapy arm, translating to an HR of 0.44 at 1 year in patients with high-risk AF and stable CAD (95% CI, 0.3-0.65; P < .001).
Incidence of the secondary efficacy outcomes of death, stroke, MI, urgent revascularization, stent thrombosis and ischemic events were each similarly low between the two treatment arms.
However, the lower observed risk for bleeding outcomes significantly favored edoxaban monotherapy compared with dual antithrombotic therapy in this patient population:
- major or clinically relevant nonmajor bleeding (HR = 0.34; 95% CI, 0.22-0.53);
- major bleeding (HR = 0.32; 95% CI, 0.14-0.73);
- clinically relevant nonmajor bleeding (HR = 0.36; 95% CI, 0.21-0.59); and
- any bleeding (HR = 0.48; 95% CI, 0.35-0.67).
“In the multicenter randomized trial, standard-dose edoxaban monotherapy was associated with a lower risk for primary net adverse clinical events — efficacy and safety outcomes combined — than edoxaban plus single antiplatelet agent in patients with AF and stable CAD,” Park said during the press conference. “This result was mainly driven by lower incidence of bleeding events. The incidence of ischemic events and mortality appeared to be similar in the trial groups.
“We believe our EPIC-CAD trial provided additional new evidence on the use of standard-dose edoxaban therapy to add to contemporary guidelines,” he said.
Reference:
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Park DW, et al. Hot line 6. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
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