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尽管在心房颤动中进行抗凝治疗,但仍存在不良事件残留的发生率和风险因素:GLORIA-AF 登记研究 II/III 期的结果。

Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry.

机构信息

Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool UK.

Department of Clinical Medicine Aalborg University Aalborg Denmark.

出版信息

J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.

DOI:10.1161/JAHA.122.026410
PMID:35876418
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9375480/
Abstract

Background Residual risk of ischemic stroke despite anticoagulation in patients with atrial fibrillation (AF) represents a significant clinical issue that remains unaddressed. We aimed to evaluate the incidence and risk factors for residual adverse events in AF. Methods and Results Using data from phase II/III of the prospective GLORIA-AF (Global Registry on Long-Term Oral Anti-thrombotic Treatment in Patients With Atrial Fibrillation) registry, we studied anticoagulated patients with newly diagnosed AF and an increased risk of stroke (CHADS-VASc ≥1). The primary outcome of interest was ischemic stroke. Secondary outcomes were all-cause death, cardiovascular death and myocardial infarction. A total of 22 410 patients were included; median age 65 (interquartile range 71-78) and 10 044 (44.8%) were female. During a median follow-up period of 3.0 (interquartile range 2.2-3.1) years, the incidence of ischemic stroke was 0.60 (95% CI, 0.54-0.67) per 100-PYs, all-cause death 3.22 (95% CI, 3.08-3.37) per 100-PYs, cardiovascular death 1.08 (95% CI, 1.00-1.16) per 100-PYs and myocardial infarction 0.59 (95% CI, 0.53-0.66) per 100-PYs. Using multivariable Cox proportional hazards analysis, independent predictors of residual ischemic stroke were age (HR 1.05 [95% CI, 1.03-1.07]), diabetes (HR 1.42 [95% CI, 1.08-1.87]), prior thromboembolism (HR 2.27 [95% CI, 1.73-2.98]) and use of antiarrhythmic drugs (HR 0.66 [95% CI, 0.47-0.92]). The incidence of ischemic stroke was comparable among patients treated with nonvitamin K antagonist oral anticoagulants versus vitamin K antagonist; however, there were differences in the independent predictors between both groups. Conclusions Patients with AF remain at significant residual risk of developing complications including ischemic stroke despite anticoagulation therapy. Further efforts among these patients should be directed at the management of modifiable risk factors that contribute to this risk. Registration URL: http://www.clinicaltrials.gov; Unique identifiers: NCT01468701, NCT01671007 and NCT01937377.

摘要

背景

尽管在心房颤动(AF)患者中进行抗凝治疗,但仍存在缺血性卒中的残余风险,这是一个尚未解决的重要临床问题。我们旨在评估 AF 中残余不良事件的发生率和危险因素。

方法和结果

使用前瞻性 GLORIA-AF(全球长期口服抗血栓治疗心房颤动患者注册研究)二期/三期研究的数据,我们研究了新诊断为 AF 且卒中风险增加(CHADS-VASc≥1)的抗凝治疗患者。主要研究终点为缺血性卒中。次要终点为全因死亡、心血管死亡和心肌梗死。共纳入 22410 例患者;中位年龄为 65 岁(四分位间距为 71-78 岁),10044 例(44.8%)为女性。中位随访 3.0 年(四分位间距为 2.2-3.1 年)期间,缺血性卒中发生率为 0.60/100 患者年(95%CI,0.54-0.67),全因死亡率为 3.22/100 患者年(95%CI,3.08-3.37),心血管死亡率为 1.08/100 患者年(95%CI,1.00-1.16),心肌梗死发生率为 0.59/100 患者年(95%CI,0.53-0.66)。采用多变量 Cox 比例风险分析,残余缺血性卒中的独立预测因素为年龄(HR 1.05[95%CI,1.03-1.07])、糖尿病(HR 1.42[95%CI,1.08-1.87])、既往血栓栓塞(HR 2.27[95%CI,1.73-2.98])和抗心律失常药物的使用(HR 0.66[95%CI,0.47-0.92])。与维生素 K 拮抗剂相比,非维生素 K 拮抗剂口服抗凝剂治疗的患者发生缺血性卒中的风险相当;然而,两组之间的独立预测因素存在差异。

结论

尽管进行了抗凝治疗,AF 患者仍存在发生包括缺血性卒中在内的严重残余并发症的风险。应进一步针对这些患者的可改变的危险因素进行管理,以降低风险。

注册网址

http://www.clinicaltrials.gov;唯一标识符:NCT01468701、NCT01671007 和 NCT01937377。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d0c/9375480/805f5b28e589/JAH3-11-e026410-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d0c/9375480/805f5b28e589/JAH3-11-e026410-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d0c/9375480/805f5b28e589/JAH3-11-e026410-g001.jpg

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