Department of Cardiology, University of Besançon, Besançon, France.
Thrombosis Research Institute, London, United Kingdom.
Blood Adv. 2021 Feb 23;5(4):1081-1091. doi: 10.1182/bloodadvances.2020003560.
In atrial fibrillation (AF), lower risks of death and bleeding with non-vitamin-K oral anticoagulants (NOACs) were reported in meta-analyses of controlled trials, but whether these findings hold true in real-world practice remains uncertain. Risks of bleeding and death were assessed in 52 032 patients with newly diagnosed AF enrolled in GARFIELD-AF (Global Anticoagulant Registry in the FIELD-Atrial Fibrillation), a worldwide prospective registry. Baseline treatment was vitamin K antagonists (VKAs) with or without antiplatelet (AP) agents (VKA ± AP) (20 151; 39.3%), NOACs ± AP agents (14 103; 27.5%), AP agents only (10 748; 21.0%), or no antithrombotics (6219; 12.1%). One-year follow-up event rates (95% confidence interval [CI]) of minor, clinically relevant nonmajor (CRNM), and major bleedings were 2.29 (2.16-2.43), 1.10 (1.01-1.20), and 1.31 (1.21-1.41) per 100 patient-years, respectively. Bleeding risk was lower with NOACs than VKAs for any bleeding (hazard ratio (HR) [95% CI]), 0.85 [0.73-0.98]) or major bleeding (0.79 [0.60-1.04]). Compared with no bleeding, the risk of death was higher with minor bleeding (adjusted HR [aHR], 1.53 [1.07-2.19]), CRNM bleeding (aHR, 2.59 [1.80-3.73]), and major bleeding (aHR, 8.24 [6.76-10.04]). The all-cause mortality rate was lower with NOACs than with VKAs (aHR, 0.73 [0.62-0.85]). Forty-five percent (114) of all deaths occurred within 30 days, and 40% of these were from intracranial/intraspinal hemorrhage (ICH). The rates of any bleeding and all-cause death were lower with NOACs than with VKAs. Major bleeding was associated with the highest risk of death. CRNM bleeding and minor bleeding were associated with a higher risk of death compared to no bleeding. Death within 30 days after a major bleed was most frequently related to ICH. This trial was registered at www.clinicaltrials.gov as #NCT01090362.
在心房颤动（AF）中，荟萃分析显示，非维生素 K 口服抗凝剂（NOACs）的死亡和出血风险较低，但这些发现是否在真实世界的实践中仍然不确定。在全球抗凝注册研究-心房颤动（GARFIELD-AF）中，评估了 52032 例新诊断为 AF 的患者的出血和死亡风险，这是一项全球性前瞻性登记研究。基线治疗为维生素 K 拮抗剂（VKA）联合或不联合抗血小板（AP）药物（VKA ± AP）（20151 例；39.3%）、NOACs ± AP 药物（14103 例；27.5%）、AP 药物（10748 例；21.0%）或无抗血栓药物（6219 例；12.1%）。1 年随访的小出血、临床相关非大出血（CRNM）和大出血发生率分别为 2.29（2.16-2.43）、1.10（1.01-1.20）和 1.31（1.21-1.41）/100 患者年。与 VKA 相比，NOACs 任何出血（风险比[95%CI]）和大出血（0.79[0.60-1.04]）的出血风险均较低。与无出血相比，轻微出血（校正 HR[aHR]，1.53[1.07-2.19]）、CRNM 出血（aHR，2.59[1.80-3.73]）和大出血（aHR，8.24[6.76-10.04]）的死亡风险更高。与 VKA 相比，NOACs 的全因死亡率较低（aHR，0.73[0.62-0.85]）。所有死亡的 45%（114 例）发生在 30 天内，其中 40%的死亡是颅内/脊髓内出血（ICH）所致。与 VKA 相比，NOACs 的出血和全因死亡率均较低。大出血与最高的死亡风险相关。与无出血相比，CRNM 出血和轻微出血与更高的死亡风险相关。出血后 30 天内死亡的患者大多与 ICH 有关。该试验在 www.clinicaltrials.gov 注册，编号为 #NCT01090362。
