Background and Aims The optimal antithrombotic therapy in patients with device-detected atrial fibrillation (DDAF) is unknown. Concomitant vascular disease can modify the benefits and risks of anticoagulation. Methods These pre-specified analyses of the NOAH-AFNET 6 (n = 2534 patients) and ARTESiA (n = 4012 patients) trials compared anticoagulation with no anticoagulation in patients with DDAF with or without vascular disease, defined as prior stroke/transient ischaemic attack, coronary or peripheral artery disease. Efficacy outcomes were the primary outcomes of both trials, a composite of stroke, systemic arterial embolism (SE), myocardial infarction, pulmonary embolism or cardiovascular death, and stroke or SE. Safety outcomes were major bleeding or major bleeding and death. Results In patients with vascular disease (NOAH-AFNET 6, 56%; ARTESiA, 46%), stroke, myocardial infarction, systemic or pulmonary embolism, or cardiovascular death occurred at 3.9%/patient-year with and 5.0%/patient-year without anticoagulation (NOAH-AFNET 6), and 3.2%/patient-year with and 4.4%/patient-year without anticoagulation (ARTESiA). Without vascular disease, outcomes were equal with and without anticoagulation (NOAH-AFNET 6, 2.7%/patient-year; ARTESiA, 2.3%/patient-year in both randomized groups). Meta-analysis found consistent results across both trials (I2heterogeneity = 6%) with a trend for interaction with randomized therapy (pinteraction = .08). Stroke/SE behaved similarly. Anticoagulation equally increased major bleeding in vascular disease patients [edoxaban, 2.1%/patient-year; no anticoagulation, 1.3%/patient-year; apixaban, 1.7%/patient-years; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.55 (1.10–2.20)] and without vascular disease [edoxaban, 2.2%/patient-year; no anticoagulation, 0.6%/patient-year; apixaban, 1.4%/patient-year; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.93 (0.72–5.20)]. Conclusions Patients with DDAF and vascular disease are at higher risk of stroke and cardiovascular events and may derive a greater benefit from anticoagulation than patients with DDAF without vascular disease.

中文翻译：

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设备检测到的心房颤动伴或不伴血管疾病的抗凝治疗：NOAH-AFNET 6 和 ARTESiA 试验的联合分析


背景和目的 设备检测到的心房颤动 （DDAF） 患者的最佳抗血栓治疗尚不清楚。伴随的血管疾病可以改变抗凝治疗的益处和风险。方法 NOAH-AFNET 6 （n = 2534 名患者） 和 ARTESiA （n = 4012 名患者） 试验的这些预先设定的分析比较了 DDAF 患者伴或不伴血管疾病（定义为既往中风/短暂性脑缺血发作、冠状动脉或外周动脉疾病）的抗凝治疗与无抗凝治疗。疗效结局是两项试验的主要结局，是卒中、全身性动脉栓塞（systemic arterial embolism， SE）、心肌梗死、肺栓塞或心血管死亡以及卒中或SE的复合结局。安全性结局是大出血或大出血和死亡。结果 在血管疾病患者 （NOAH-AFNET 6， 56%;ARTESiA，46%）、中风、心肌梗死、全身性或肺栓塞或心血管死亡的发生率为 3.9%/患者年和 5.0%/患者年无抗凝治疗 （NOAH-AFNET 6），3.2%/患者年和4.4%/患者年无抗凝治疗 （ARTESiA）。无血管疾病，有和没有抗凝治疗的结局相同 （NOAH-AFNET 6,2.7%/患者年;ARTESiA，两个随机组均为 2.3%/患者年）。荟萃分析发现，两项试验的结果一致 （I2 异质性 = 6%），与随机疗法的相互作用有趋势 （pinteraction = .08）。Stroke/SE 的行为类似。抗凝治疗同样增加了血管疾病患者的大出血 [依度沙班，2.1%/患者年;无抗凝治疗，1.3%/患者年;阿哌沙班，1.7%/患者年;无抗凝治疗，1.1%/患者年;发病率比 1.55 （1.10-2.20）] 和无血管疾病 [依度沙班，2.2%/患者年;无抗凝治疗，0.6%/患者年;阿哌沙班，1.4%/患者年;无抗凝治疗，1.1%/患者年;发病率比 1.93 （0.72–5.20）]。结论 与无血管疾病的 DDAF 患者相比，患有血管疾病的 DDAF 患者发生卒中和心血管事件的风险更高，并且可能从抗凝中获得更大的益处。