Centre for Cardiovascular Science, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.
Thrombosis Research Institute, Manresa Road, London, SW3 6LR, UK.
Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.
AIMS: To determine whether the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) integrated risk tool predicts mortality, non-haemorrhagic stroke/systemic embolism, and major bleeding for up to 2 years after new-onset AF and to assess how this risk tool performs compared with CHA2DS2-VASc and HAS-BLED. METHODS AND RESULTS: Potential predictors of events included demographic and clinical characteristics, choice of treatment, and lifestyle factors. A Cox proportional hazards model was identified for each outcome by least absolute shrinkage and selection operator methods. Indices were evaluated in comparison with CHA2DS2-VASc and HAS-BLED risk predictors. Models were validated internally and externally in ORBIT-AF and Danish nationwide registries. Among the 52 080 patients enrolled in GARFIELD-AF, 52 032 had follow-up data. The GARFIELD-AF risk tool outperformed CHA2DS2-VASc for all-cause mortality in all cohorts. The GARFIELD-AF risk score was superior to CHA2DS2-VASc for non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in internal validation and in the Danish AF cohort. In very low- to low-risk patients [CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)], the GARFIELD-AF risk score offered strong discriminatory value for all the endpoints when compared to CHA2DS2-VASc and HAS-BLED. The GARFIELD-AF tool also included the effect of oral anticoagulation (OAC) therapy, thus allowing clinicians to compare the expected outcome of different anticoagulant treatment decisions [i.e. no OAC, non-vitamin K antagonist (VKA) oral anticoagulants, or VKAs]. CONCLUSIONS: The GARFIELD-AF risk tool outperformed CHA2DS2-VASc at predicting death and non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in overall as well as in very low- to low-risk group patients with AF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF: NCT01090362, ORBIT-AF I: NCT01165710; ORBIT-AF II: NCT01701817.
目的:确定新发性心房颤动(AF)后 2 年内,全球抗凝剂注册在 FIELD-AF(GARFIELD-AF)综合风险工具是否能预测死亡率、非出血性卒中和全身性栓塞以及大出血,并评估该风险工具与 CHA2DS2-VASc 和 HAS-BLED 相比表现如何。
方法和结果:事件的潜在预测因子包括人口统计学和临床特征、治疗选择和生活方式因素。通过最小绝对收缩和选择算子方法为每种结局确定 Cox 比例风险模型。通过与 CHA2DS2-VASc 和 HAS-BLED 风险预测因子比较,评估指数。在 ORBIT-AF 和丹麦全国登记处内部和外部验证模型。在 GARFIELD-AF 中登记的 52080 名患者中,52032 名患者有随访数据。在所有队列中,GARFIELD-AF 风险工具在全因死亡率方面均优于 CHA2DS2-VASc。在非出血性卒中和大出血方面,GARFIELD-AF 风险评分优于 CHA2DS2-VASc,在内部验证和丹麦 AF 队列中,优于 HAS-BLED。在极低至低风险患者[CHA2DS2-VASc 0 或 1(男性)和 1 或 2(女性)]中,与 CHA2DS2-VASc 和 HAS-BLED 相比,GARFIELD-AF 风险评分在所有终点均具有很强的判别能力。GARFIELD-AF 工具还包括口服抗凝剂(OAC)治疗的效果,因此允许临床医生比较不同抗凝治疗决策的预期结果[即无 OAC、非维生素 K 拮抗剂(VKA)口服抗凝剂或 VKA]。
结论:GARFIELD-AF 风险工具在预测死亡和非出血性卒中和大出血方面优于 CHA2DS2-VASc,在 AF 患者的整体和极低至低风险组中,优于 HAS-BLED。
临床试验注册:网址:http://www.clinicaltrials.gov。GARFIELD-AF 的独特标识符:NCT01090362,ORBIT-AF I:NCT01165710;ORBIT-AF II:NCT01701817。
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