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Mortality in Patients With Atrial Fibrillation Receiving Nonrecommended Doses of Direct Oral Anticoagulants
Journal of the American College of Cardiology ( IF 24.0 ) Pub Date : 2020-09-01 , DOI: 10.1016/j.jacc.2020.07.045
Alan John Camm 1 , Frank Cools 2 , Saverio Virdone 3 , Jean-Pierre Bassand 4 , David Andrew Fitzmaurice 5 , Keith Alexander Arthur Fox 6 , Samuel Zachary Goldhaber 7 , Shinya Goto 8 , Sylvia Haas 9 , Lorenzo Giovanni Mantovani 10 , Gloria Kayani 3 , Alexander Graham Grierson Turpie 11 , Freek Willem Antoon Verheugt 12 , Ajay Kumar Kakkar 13 ,
Affiliation  

BACKGROUND The recommended doses for direct oral anticoagulants (DOACs) to prevent stroke and systemic embolism (SE) in patients with atrial fibrillation (AF) are described in specific regulatory authority approvals. OBJECTIVES The impact of DOAC dosing, according to the recommended guidance on all-cause mortality, stroke/SE, and major bleeding, was assessed at 2-year follow-up in patients with newly diagnosed AF. METHODS Of a total of 34,926 patients enrolled (2013 to 2016) in the prospective GARFIELD-AF (Global Anticoagulant Registry in the FIELD-AF), 10,426 patients received a DOAC. RESULTS The majority of patients (72.9%) received recommended dosing, 23.2% were underdosed, and 3.8% were overdosed. Nonrecommended dosing (underdosage and overdosage combined) compared with recommended dosing was associated with a higher risk of all-cause mortality (hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 1.04 to 1.48); HR: 1.25 (95% CI: 1.04 to 1.50) for underdosing, and HR: 1.19 (95% CI: 0.83 to 1.71) for overdosing. The excess deaths were cardiovascular including heart failure and myocardial infarction. The risks of stroke/SE and major bleeding were not significantly different irrespective of the level of dosing, although underdosed patients had a significantly lower risk of bleeding. A nonsignificant trend to higher risks of stroke/SE (HR: 1.51; 95% CI: 0.79 to 2.91) and major bleeding (HR: 1.29; 95% CI: 0.59 to 2.78) was observed in patients with overdosing. CONCLUSIONS In GARFIELD-AF, most patients received the recommended DOAC doses according to country-specific guidelines. Prescription of nonrecommended doses was associated with an increased risk of death, mostly cardiovascular death, compared with patients on recommended doses, after adjusting for baseline factors. (Global Anticoagulant Registry in the Field-AF [GARFIELD-AF]; NCT01090362).

中文翻译:

接受非推荐剂量的直接口服抗凝剂的房颤患者的死亡率

背景 直接口服抗凝剂 (DOAC) 用于预防房颤 (AF) 患者中风和全身性栓塞 (SE) 的推荐剂量在特定监管机构的批准中有所描述。目标 根据对全因死亡率、卒中/SE 和大出血的推荐指南,在新诊断的 AF 患者的 2 年随访中评估了 DOAC 剂量的影响。方法 在前瞻性 GARFIELD-AF(FIELD-AF 全球抗凝剂登记)中,共有 34,926 名患者(2013 年至 2016 年)入组,其中 10,426 名患者接受了 DOAC。结果 大多数患者 (72.9%) 接受了推荐剂量,23.2% 剂量不足,3.8% 剂量过量。与推荐剂量相比,非推荐剂量(剂量不足和剂量过量相结合)与更高的全因死亡风险相关(风险比 [HR]:1.24;95% 置信区间 [CI]:1.04 至 1.48);HR:1.25(95% CI:1.04 至 1.50)表示给药不足,HR:1.19(95% CI:0.83 至 1.71)表示给药过量。超额死亡是心血管疾病,包括心力衰竭和心肌梗塞。无论给药水平如何,卒中/SE 和大出血的风险没有显着差异,尽管剂量不足的患者出血风险显着降低。在用药过量的患者中观察到卒中/SE(HR:1.51;95% CI:0.79 至 2.91)和大出血(HR:1.29;95% CI:0.59 至 2.78)风险升高的非显着趋势。结论 在 GARFIELD-AF 中,大多数患者根据国家特定指南接受了推荐的 DOAC 剂量。在调整基线因素后,与推荐剂量的患者相比,非推荐剂量的处方与死亡风险增加有关,主要是心血管死亡。(Field-AF 中的全球抗凝剂注册 [GARFIELD-AF];NCT01090362)。
更新日期:2020-09-01
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