有或无血管疾病的器械检测到的心房颤动的抗凝治疗：NOAH-AFNET 6和ARTESiA试验的联合分析
Anticoagulation in device-detected atrial fibrillation with or without vascular disease: a combined analysis of the NOAH-AFNET 6 and ARTESiA trials.
作者信息
Schnabel Renate B, Benezet-Mazuecos Juan, Becher Nina, McIntyre William F, Fierenz Alexander, Lee Shun Fu, Goette Andreas, Atar Dan, Bertaglia Emanuele, Benz Alexander P, Chlouverakis Gregory, Birnie David H, Dichtl Wolfgang, Blomstrom-Lundqvist Carina, Camm A John, Erath Julia W, Simantirakis Emmanuel, Kutyifa Valentina, Lip Gregory Y H, Mabo Philippe, Marijon Eloi, Rivard Lena, Schotten Ulrich, Alings Marco, Sehner Susanne, Toennis Tobias, Linde Cecilia, Vardas Panos, Granger Christopher B, Zapf Antonia, Lopes Renato D, Healey Jeff S, Kirchhof Paulus
机构信息
Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Hamburg, Germany.
出版信息
Eur Heart J. 2024 Dec 7;45(46):4902-4916. doi: 10.1093/eurheartj/ehae596.
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.
背景与目的
设备检测到的心房颤动（DDAF）患者的最佳抗栓治疗方案尚不清楚。合并血管疾病会改变抗凝治疗的获益与风险。
方法
对NOAH-AFNET 6试验（n = 2534例患者）和ARTESiA试验（n = 4012例患者）进行这些预先设定的分析，比较有无血管疾病（定义为既往卒中/短暂性脑缺血发作、冠状动脉或外周动脉疾病）的DDAF患者抗凝与不抗凝的情况。疗效结局为两项试验的主要结局，即卒中、系统性动脉栓塞（SE）、心肌梗死、肺栓塞或心血管死亡的复合结局，以及卒中或SE。安全性结局为大出血或大出血及死亡。
结果
在有血管疾病的患者中（NOAH-AFNET 6试验中占56%；ARTESiA试验中占46%），抗凝组和不抗凝组的卒中、心肌梗死、系统性或肺栓塞或心血管死亡发生率分别为3.9%/患者年和5.0%/患者年（NOAH-AFNET 6试验），以及3.2%/患者年和4.4%/患者年（ARTESiA试验）。无血管疾病时，抗凝组和不抗凝组的结局相当（NOAH-AFNET 6试验中均为2.7%/患者年；ARTESiA试验中两个随机分组均为2.3%/患者年）。荟萃分析发现两项试验结果一致（I²异质性 = 6%），且有与随机治疗相互作用的趋势（相互作用p值 = 0.08）。卒中/SE的情况类似。抗凝同样增加了有血管疾病患者的大出血发生率[依度沙班，2.1%/患者年；不抗凝，1.3%/患者年；阿哌沙班，1.7%/患者年；不抗凝，1.1%/患者年；发生率比值1.55（1.10 - 2.20）]和无血管疾病患者的大出血发生率[依度沙班，2.2%/患者年；不抗凝，0.6%/患者年；阿哌沙班，1.4%/患者年；不抗凝，1.1%/患者年；发生率比值1.93（0.72 - 5.20）]。
结论
与无血管疾病的DDAF患者相比，有血管疾病的DDAF患者发生卒中和心血管事件的风险更高，抗凝治疗可能使其获益更大。
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