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Published on: February 28, 2012
Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease
Min Soo Cho1, Do-Yoon Kang1, Jung-Min Ahn1
1From the Department of Cardiology (M.S.C., D.-Y.K., J.-M.A., S.-J.P., D.-W.P., G.-B.N.) and the Division of Biostatics (S.-C.Y.), Asan Medical Center, University of Ulsan College of Medicine, the Department of Cardiology, Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea (Y.-S.O.), the Department of Cardiology, Veterans Health Service Medical Center (C.H.L.), the Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital (E.-K.C.), the Division of Cardiology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine (C.H.K.), the Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine (K.-M.P.), the Department of Cardiology, Kyung Hee University Hospital at Gangdong, Kyung Hee University Medical College (E.-S.J.), and the Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, Catholic University of Korea (O.K.), Seoul, the Cardiovascular Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam (J.H.L.), the Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan (G.-M.P.), the Department of Cardiology, Soon Chun Hyang University Hospital Bucheon, Bucheon (H.O.C.), the Department of Cardiology, Hallym University Medical Center, Anyang (K.-H.P.), the Department of Cardiology, Keimyung University Dongsan Hospital, Daegu (J.H.), the Department of Cardiology, St. Vincent's Hospital, College of Medicine, Catholic University of Korea, Suwon (K.-D.Y.), the Department of Cardiology, Dong-A University Hospital, Dong-A University College of Medicine (Y.-R.C.), and the Department of Cardiology, Haeundae Paik Hospital, Inje University College of Medicine (K.-H.K.), Busan, the Department of Cardiology, Dongguk University Ilsan Hospital, Goyang (J.H.K.), and the Department of Cardiology, Pusan National University Yangsan Hospital, Pusan National University of Medicine, Yangsan (K.W.H.) - all in South Korea.
Insights
Edoxaban monotherapy significantly reduced the risk of major adverse events in patients with atrial fibrillation and stable coronary artery disease compared to dual antithrombotic therapy. This strategy also lowered the incidence of major bleeding events.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Long-term antithrombotic treatment strategies for patients with atrial fibrillation and stable coronary artery disease lack robust randomized trial data.
- Clinical guidelines consistently recommend antithrombotic therapy, but optimal long-term approaches require further investigation.
Purpose of the Study:
- To compare the efficacy and safety of edoxaban monotherapy versus dual antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease.
- To evaluate the long-term risk of composite adverse events, including death, ischemic events, and bleeding, in this patient population.
Main Methods:
- A multicenter, open-label, adjudicator-masked randomized trial involving 1040 patients.
- Patients with atrial fibrillation and stable coronary artery disease were randomized to receive either edoxaban monotherapy or dual antithrombotic therapy (edoxaban plus a single antiplatelet agent).
- The primary outcome was a composite of death, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major or clinically relevant nonmajor bleeding at 12 months.
Main Results:
- Edoxaban monotherapy resulted in a significantly lower incidence of the primary composite outcome compared to dual antithrombotic therapy (6.8% vs. 16.2%; hazard ratio, 0.44; P<0.001).
- Major bleeding or clinically relevant nonmajor bleeding occurred less frequently with edoxaban monotherapy (4.7% vs. 14.2%; hazard ratio, 0.34).
- The cumulative incidence of major ischemic events was similar between the two groups.
Conclusions:
- Edoxaban monotherapy is associated with a reduced risk of major adverse events and bleeding in patients with atrial fibrillation and stable coronary artery disease compared to dual antithrombotic therapy.
- This study provides crucial evidence supporting edoxaban monotherapy as a potentially safer and effective long-term antithrombotic strategy for this patient cohort.
Background:
Despite consistent recommendations from clinical guidelines, data from randomized trials on a long-term antithrombotic treatment strategy for patients with atrial fibrillation and stable coronary artery disease are still lacking.
Methods:
We conducted a multicenter, open-label, adjudicator-masked, randomized trial comparing edoxaban monotherapy with dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) in patients with atrial fibrillation and stable coronary artery disease (defined as coronary artery disease previously treated with revascularization or managed medically). The risk of stroke was assessed on the basis of the CHA2DS2-VASc score (scores range from 0 to 9, with higher scores indicating a greater risk of stroke). The primary outcome was a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major bleeding or clinically relevant nonmajor bleeding at 12 months. Secondary outcomes included a composite of major ischemic events and the safety outcome of major bleeding or clinically relevant nonmajor bleeding.
Results:
We assigned 524 patients to the edoxaban monotherapy group and 516 patients to the dual antithrombotic therapy group at 18 sites in South Korea. The mean age of the patients was 72.1 years, 22.9% were women, and the mean CHA2DS2-VASc score was 4.3. At 12 months, a primary-outcome event had occurred in 34 patients (Kaplan-Meier estimate, 6.8%) assigned to edoxaban monotherapy and in 79 patients (16.2%) assigned to dual antithrombotic therapy (hazard ratio, 0.44; 95% confidence interval [CI], 0.30 to 0.65; P<0.001). The cumulative incidence of major ischemic events at 12 months appeared to be similar in the trial groups. Major bleeding or clinically relevant nonmajor bleeding occurred in 23 patients (Kaplan-Meier estimate, 4.7%) in the edoxaban monotherapy group and in 70 patients (14.2%) in the dual antithrombotic therapy group (hazard ratio, 0.34; 95% CI, 0.22 to 0.53).
Conclusions:
In patients with atrial fibrillation and stable coronary artery disease, edoxaban monotherapy led to a lower risk of a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months than dual antithrombotic therapy. (Funded by the CardioVascular Research Foundation and others; EPIC-CAD ClinicalTrials.gov number, NCT03718559.).
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