Anticoagulation with edoxaban in patients with long atrial high-rate episodes ≥24 h

• Published in: European heart journal Vol. 45; no. 10; pp. 837 - 849
• Main Authors: Becher, Nina, Toennis, Tobias, Bertaglia, Emanuele, Blomström-Lundqvist, Carina, Brandes, Axel, Cabanelas, Nuno, Calvert, Melanie, Camm, A John, Chlouverakis, Gregory, Dan, Gheorghe-Andrei, Dichtl, Wolfgang, Diener, Hans Christoph, Fierenz, Alexander, Goette, Andreas, de Groot, Joris R, Hermans, Astrid N L, Lip, Gregory Y H, Lubinski, Andrzej, Marijon, Eloi, Merkely, Béla, Mont, Lluís, Ozga, Ann-Kathrin, Rajappan, Kim, Sarkozy, Andrea, Scherr, Daniel, Schnabel, Renate B, Schotten, Ulrich, Sehner, Susanne, Simantirakis, Emmanuel, Vardas, Panos, Velchev, Vasil, Wichterle, Dan, Zapf, Antonia, Kirchhof, Paulus
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 07.03.2024
• Subjects: Aged; Aged, 80 and over; Anticoagulants - therapeutic use; Atrial fibrillation; Atrial Fibrillation - complications; Atrial Fibrillation - diagnosis; Atrial Fibrillation - drug therapy; Atrial high-rate episodes; Fast Track Clinical Research; Female; Heart Atria; Humans; Male; NOAH-AFNET 6; Pyridines; Risk Factors; Stroke; Stroke - diagnosis; Stroke - etiology; Stroke - prevention & control; Thiazoles; NOAH-AFNET 6; Stroke; Atrial fibrillation; Atrial high-rate episodes
• ISSN: 0195-668X; 1522-9645; 1522-9645
• DOI: 10.1093/eurheartj/ehad771

Abstract Background and Aims Patients with long atrial high-rate episodes (AHREs) ≥24 h and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared with no anticoagulation in these patients. Methods This secondary pre-specified analysis of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes (NOAH-AFNET 6) trial examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared with placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and electrocardiogram (ECG)-diagnosed atrial fibrillation. Results Median follow-up of 2389 patients with core lab-verified AHRE was 1.8 years. AHRE ≥24 h were present at baseline in 259/2389 patients (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc 4). Clinical characteristics were not different from patients with shorter AHRE. The primary outcome occurred in 9/132 patients with AHRE ≥24 h (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). Atrial high-rate episode duration did not interact with the efficacy (P-interaction = .65) or safety (P-interaction = .98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 h developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; P < .001). Conclusions This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk. Structured Graphical Abstract Structured Graphical Abstract Anticoagulation with edoxaban in patients with long AHRE ≥24 h. AHRE, atrial high-rate episodes; CI, confidence interval; ECG, electrocardiogram; HR, hazard ratio.