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