Anguita Sánchez Manuel, Bertomeu Martínez Vicente, Ruiz Ortiz Martín, Cequier Fillat Ángel, Roldán Rabadán Inmaculada, Muñiz García Javier, Badimón Maestro Lina, Esteve Pastor María Asunción, Marín Ortuño Francisco
Servicio de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain.
Servicio de Cardiología, Hospital Universitario de San Juan, San Juan de Alicante, Alicante, Spain.
Rev Esp Cardiol (Engl Ed). 2020 Jan;73(1):14-20. doi: 10.1016/j.rec.2019.02.021. Epub 2019 May 31.
To compare the long-term results of direct oral anticoagulants (DOAC) vs vitamin K antagonists (VKA) in real-world-patients with nonvalvular atrial fibrillation (NVAF) in a nationwide, prospective study.
The FANTASIIA registry prospectively included outpatients with AF anticoagulated with DOAC or VKA (per protocol, proportion of VKA and DOAC 4:1), consecutively recruited from June 2013 to October 2014 in Spain. The incidence of major events was analyzed and compared according to the anticoagulant treatment received.
A total of 2178 patients were included in the study (mean age 73.8±9.4 years), and 43.8% were women. Of these, 533 (24.5%) received DOAC and 1645 (75.5%) VKA. After a median follow up of 32.4 months, patients receiving DOAC vs those receiving VKA had lower rates of stroke-0.40 (95%CI, 0.17-0.97) vs 1.07 (95%CI,0.79-1.46) patients/y, P=.032-, severe bleedings-2.13 (95%CI, 1.45-3.13) vs 3.28 (95%CI, 2.75-3.93) patients/y; P = .044-, cardiovascular death-1.20 (95%CI, 0.72-1.99) vs 2.45 (95%CI, 2.00-3.00) patients/y; P = .009-, and all-cause death-3.77 (95%CI, 2.83-5.01) vs 5.54 (95%CI, 4.83-6.34) patients/y; P = .016-. In a modified Cox regression model by the Andersen-Gill method for multiple events, hazard ratios for patients receiving DOAC were: 0.42 (0.16-1.07) for stroke; 0.47 (0.20-1.16) for total embolisms; 0.76 (0.50-1.15) for severe bleedings; 0.67 (0.39-1.18) for cardiovascular death; 0.86 (0.62-1.19) for all-cause death, and 0.82 (0.64-1.05) for the combined event consisting of stroke, embolism, severe bleeding, and all-cause death.
Compared with VKA, DOAC is associated with a trend to a lower incidence of all major events, including death, in patients with NVAF in Spain.
在一项全国性前瞻性研究中，比较直接口服抗凝剂（DOAC）与维生素K拮抗剂（VKA）用于非瓣膜性心房颤动（NVAF）真实世界患者的长期疗效。
FANTASIIA注册研究前瞻性纳入接受DOAC或VKA抗凝治疗的房颤门诊患者（按照方案，VKA与DOAC的比例为4:1），于2013年6月至2014年10月在西班牙连续招募。根据接受的抗凝治疗分析并比较主要事件的发生率。
该研究共纳入2178例患者（平均年龄73.8±9.4岁），43.8%为女性。其中，533例（24.5%）接受DOAC，1645例（75.5%）接受VKA。中位随访32.4个月后，接受DOAC的患者与接受VKA的患者相比，卒中发生率较低（分别为0.40例/年（95%CI，0.17 - 0.97） vs 1.07例/年（95%CI，0.79 - 1.46），P = 0.032）、严重出血发生率较低（分别为2.13例/年（95%CI，1.45 - 3.13） vs 3.28例/年（95%CI，2.75 - 3.93）；P = 0.044）、心血管死亡发生率较低（分别为1.20例/年（95%CI，0.72 - 1.99） vs 2.45例/年（95%CI，2.00 - 3.00）；P = 0.009）以及全因死亡发生率较低（分别为3.77例/年（95%CI，2.83 - 5.01） vs 5.54例/年（95%CI，4.83 - 6.34）；P = 0.016）。在采用Andersen - Gill方法处理多事件的改良Cox回归模型中，接受DOAC患者的风险比为：卒中0.42（0.16 - 1.07）；总栓塞0.47（0.20 - 1.16）；严重出血0.76（0.50 - 1.15）；心血管死亡0.67（0.39 - 1.18）；全因死亡0.86（0.62 - 1.19）；由卒中、栓塞、严重出血和全因死亡组成的联合事件为0.82（0.64 - 1.05）。
在西班牙NVAF患者中，与VKA相比，DOAC与包括死亡在内的所有主要事件发生率降低的趋势相关。
