Department of Neuroepidemiology Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Duisburg-Essen Essen Germany.
Department of Cardiology University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf Hamburg Germany.
J Am Heart Assoc. 2024 Sep 3;13(17):e036429. doi: 10.1161/JAHA.124.036429. Epub 2024 Aug 27.
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.
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).
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.
在既往有卒中或短暂性脑缺血发作（TIA）病史的患者中，常通过植入设备（设备检测到的 AF）检测到短暂且罕见的心房颤动（AF）发作。既往有卒中或 TIA 病史且设备检测到 AF 但无心电图记录 AF 的患者，使用口服抗凝剂的有效性和安全性尚不清楚。
本研究是对 NOAH-AFNET 6（非维生素 K 拮抗剂口服抗凝剂在心房高频率发作患者中的应用）试验的预设分析，其中包含事后要素，评估了在随机、双盲、双模拟的 NOAH-AFNET 6 试验中，口服抗凝剂在设备检测到 AF 且既往有或无卒中或 TIA 的患者中的作用。结局为卒中、全身性栓塞和心血管死亡（主要结局）以及大出血和死亡（安全性结局）。NOAH-AFNET 6 试验中，253 例设备检测到 AF 的患者随机分为两组，其中 253 例患者既往有卒中或 TIA（平均年龄 78 岁，36.4%为女性）。对于任何主要和次要时间事件结局，既往有卒中或 TIA 与治疗之间均无相互作用。在既往有卒中或 TIA 的患者中，14 例患者接受抗凝治疗时发生主要结局事件（每患者年 5.7%）。未接受抗凝治疗的患者中，16 例患者发生事件（每患者年 6.3%）。卒中发生率低于预期（抗凝治疗：每患者年 4 例[1.6%]；未抗凝治疗：每患者年 6 例[2.3%]）。数值上，在既往有卒中或 TIA 的患者中，抗凝治疗组的大出血事件多于未抗凝治疗组（抗凝治疗组 8 例患者，未抗凝治疗组 2 例患者）。
在没有心电图记录 AF 的情况下，NOAH-AFNET 6 试验的这一假设生成分析中，在设备检测到 AF 且既往有卒中或 TIA 的患者中，抗凝治疗的效果似乎不确定，部分原因是未抗凝治疗时卒中发生率较低。
