Edoxaban-based long-term antithrombotic therapy in patients with atrial fibrillation and stable coronary disease: Rationale and design of the randomized EPIC-CAD trial.

BACKGROUND: Anticoagulants are the standard therapy for patients with atrial fibrillation (AF) and antiplatelet therapy for those with coronary artery disease (CAD). However, compelling clinical evidence is still lacking regarding the long-term maintenance strategy with the combination of anticoagulant and antiplatelet drugs in patients with AF and stable CAD. DESIGN: The EPIC-CAD trial is an investigator-initiated, multicenter, open-label randomized trial comparing the safety and efficacy of 2 antithrombotic strategies in patients with high-risk AF (CHA2DS2-VASc score ≥ 2 points) and stable CAD (≥6 months after revascularization for stable angina or ≥12 months for acute coronary syndrome; or medical therapy alone). Patients (approximately N = 1,038) will be randomly assigned at a 1:1 ratio to (1) monotherapy with edoxaban (a non-vitamin K antagonist oral anticoagulant) or (2) combination therapy with edoxaban plus a single antiplatelet agent. The primary endpoint is the net composite outcome of death from any cause, stroke, systemic embolism, myocardial infarction, unplanned revascularization, and major or clinically relevant nonmajor bleeding at 1 year after randomization. RESULTS: As of December 2021, approximately 901 patients had been randomly enrolled over 2 years at 18 major cardiac centers across South Korea. The completed enrollment is expected at the mid-term of 2022, and the primary results will be available by 2023. CONCLUSIONS: EPIC-CAD is a large-scale, multicenter, pragmatic design trial, which will provide valuable clinical insight into edoxaban-based long-term antithrombotic therapy in patients with high-risk AF and stable CAD.

Standard-Intensity Versus Low-Intensity Anticoagulation with Warfarin in Asian Patients with Atrial Fibrillation: A Multi-Center, Randomized Controlled Trial.

Anticoagulation with warfarin in Asian patients with atrial fibrillation (AF) often has been decreased as an international normalized ratio (INR) of prothrombin time 1.6-2.6 due to fear of bleeding, although universal criteria recommend an INR of 2.0-3.0. In this randomized, open-label trial, low-intensity anticoagulation (INR 1.6-2.6) was compared with standard-intensity anticoagulation (INR 2.0-3.0) with warfarin. A total 616 patients with AF and at least 1 risk factor for stroke were randomized to low-intensity anticoagulation (n = 308) and standard-intensity anticoagulation (n = 308) groups. The intention-to-treat analysis was performed to determine differences. The baseline characteristics of the two groups were comparable. New-onset stroke occurred in 2 patients (0.44% per year) in the low-intensity group and 5 patients (1.05% per year) in the standard-intensity group (HR 0.42, 95% CI 0.08-2.15). Major bleeding occurred in 4 patients (0.89% per year) in the low-intensity group and 5 patients (1.06% per year) in the standard-intensity group (HR 0.84, 95% CI 0.22-3.11). The rate of the net clinical outcome (composite of stroke, systemic embolism, major bleeding, and death) was 1.33% per year in the low-intensity group compared with 2.12% per year in the standard-intensity group (HR 0.63, 95% CI 0.23-1.72). In Asian patients with AF, clinical outcomes were not different between low-intensity and standard-intensity anticoagulation with warfarin.

Comparison of Mobile Application-Based ECG Consultation by Collective Intelligence and ECG Interpretation by Conventional System in a Tertiary-Level Hospital.

BACKGROUND AND OBJECTIVES: A mobile application (app)-based electrocardiogram (ECG) consultation system (InterMD Co., Ltd., Seoul, Korea) using the collective intelligence (CI) and the availability of large-scale digitized ECG data would extend the utility of ECGs beyond their current limitations, while at the same time preserving interpretability that remains critical to medical decision-making. METHODS: We developed a new mobile app-based ECG consultation system by CI for general practitioners. We compared the responses of ECG reading between the mobile app-based CI system and the conventional system in a tertiary referring hospital. RESULTS: We analyzed 376 consecutive ECGs between December 2017 and May 2019. Of these, 159 ECGs (42.3%) were interpreted by CI through the mobile app-based ECG consultation system and 217 ECGs (57.7%) were analyzed by cardiologists in the conventional systems based on electronic medical record data in a tertiary hospital. All ECG readings were confirmed by an electrophysiologist (EP). The time to an initial response by the CI system was faster than that of the conventional system (6.6 hours vs. 35.8 hours, p<0.0001). The number of responses of each ECG in CI system outnumbered those of the conventional system in the tertiary hospital (3.1 vs. 1.2, p<0.0001). The consensus of the ECG readings with EP was similar in both systems (98.6% vs. 100%, p=0.158). CONCLUSIONS: The mobile app-based ECG consultation system by CI is as reliable method as the conventional referral system. It would expand the app of the 12-lead ECG with the collaboration of physicians in clinics and hospitals without time and space constraints.

The shape of the left lateral ridge as a predictor of long-term outcome of catheter ablation for atrial fibrillation based on clinical and experimental data.

BACKGROUND: The left lateral ridge (LLR) is an important structure for ablation of atrial fibrillation (AF). This study assessed how the LLR shape is associated with the long-term outcomes of AF ablation and investigated the relationship with radiofrequency (RF) lesion formation. METHODS AND RESULTS: Clinical study - we assessed multi-detector computed tomography (MDCT) images in 247 patients who underwent AF ablation. Patients were classified into two groups according to the shape of the LLR: Narrow LLR group (n = 116; 47%) and Wide LLR group (n = 131; 53%). After a follow-up period 475 ± 245 days, the AF-free rate was significantly higher in the wide LLR than Narrow LLR group (83.2% vs. 62.9%, p = 0.0004). A multivariate analysis showed that the shape of the LLR was an independent predictor of AF recurrence after ablation (hazard ratio 2.58; 95% confidential interval = 1.48-4.51, p = 0.001). Experimental study - Two types of the ridge models were made with porcine atrial tissues: "Narrow ridge(4.2 ± 0.9 mm)" and "Wide ridge(9.7 ± 1.8 mm)" RF ablation was performed on each ridge model using a contact force (CF)-sensing catheter. The mean CF and the RF lesion volume of the narrow ridge were significantly less than those of the wide ridge model (5.42 ± 3.13 g vs. 10.37 ± 3.98 g, p = 0.001; 19.8 ± 9.9 mm3 vs. 44.2 ± 13.6 mm3, p < 0.001, respectively). CONCLUSIONS: AF recurrence after ablation was more frequent in patients with a narrow LLR. LLR shape as assessed using MDCT is associated with long-term outcomes after AF ablation. CF and lesion formation data using the porcine atrial tissue model support our clinical results.