Nejvíce citovaný článek - PubMed ID 37622677
Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes
BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear. METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients). CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.
- Klíčová slova
- CHA2DS2‐VASc score, NOAH‐AFNET 6, anticoagulation, atrial fibrillation, device‐detected atrial fibrillation, recurrent stroke,
- MeSH
- antikoagulancia * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- aplikace orální MeSH
- časové faktory MeSH
- cévní mozková příhoda * prevence a kontrola etiologie MeSH
- dvojitá slepá metoda MeSH
- fibrilace síní * farmakoterapie komplikace diagnóza MeSH
- kardiostimulátor MeSH
- krvácení chemicky indukované MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- tranzitorní ischemická ataka * prevence a kontrola etiologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antikoagulancia * MeSH
- Klíčová slova
- Anticoagulation, Atrial fibrillation, Atrial high-rate episodes, Bleeding, CHA2DS2-VASc score, Device-detected atrial fibrillation, Kidney function, NOAH-AFNET 6, Stroke,
- MeSH
- antikoagulancia * aplikace a dávkování terapeutické užití MeSH
- aplikace orální MeSH
- cévní mozková příhoda prevence a kontrola epidemiologie MeSH
- fibrilace síní * farmakoterapie komplikace MeSH
- kardiovaskulární nemoci prevence a kontrola epidemiologie MeSH
- komorbidita MeSH
- lidé MeSH
- senioři MeSH
- sexuální faktory MeSH
- věkové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
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.
- Klíčová slova
- Atrial fibrillation, Atrial high-rate episodes, NOAH-AFNET 6, Stroke,
- MeSH
- antikoagulancia terapeutické užití MeSH
- cévní mozková příhoda * etiologie prevence a kontrola diagnóza MeSH
- fibrilace síní * komplikace farmakoterapie diagnóza MeSH
- lidé MeSH
- pyridiny * MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční síně MeSH
- thiazoly * MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- antikoagulancia MeSH
- edoxaban MeSH Prohlížeč
- pyridiny * MeSH
- thiazoly * MeSH