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Original article
DOI: 10.1016/j.rec.2019.02.021
Available online 1 June 2019
Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study
Anticoagulantes orales directos frente a antagonistas de la vitamina K en pacientes del «mundo real» con fibrilación auricular no valvular. Estudio FANTASIIA
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Manuel Anguita Sáncheza,
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manuelanguita@secardiolog??a.es

Corresponding author: Servicio de Cardiología, Hospital Universitario Reina Sofía, Avda. Menéndez Pidal 1, 14004 Córdoba, Spain.
, Vicente Bertomeu Martínezb, Martín Ruiz Ortiza, Ángel Cequier Fillatc, Inmaculada Roldán Rabadánd, Javier Muñiz Garcíae, Lina Badimón Maestrof, María Asunción Esteve Pastorg, Francisco Marín Ortuñog, on behalf of the FANTASIIA study investigators
a Servicio de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain
b Servicio de Cardiología, Hospital Universitario de San Juan, San Juan de Alicante, Alicante, Spain
c Servicio de Cardiología, Hospital Universitario de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain
d Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain
e Universidad de A Coruña, A Coruña, Spain
f Instituto de Investigación Cardiovascular (CSIC-ICCC)-Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
g Servicio de Cardiología, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, CIBERCV, EL Palmar, Murcia, Spain
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10.1016/j.rec.2019.06.010
José Ramón López-Mínguez, Juan Manuel Nogales-Asensio, Reyes González-Fernández
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Received 02 October 2018. Accepted 14 February 2019
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Table 1. Baseline characteristics of the patients in the total sample and in the 2 anticoagulant therapy groups (VKA and DOAC)
Table 2. Crude event rate/100 patients/year in the total sample and in the VKA and DOAC groups
Table 3. Risk ratios for the various events between patients receiving DOACs and those taking VKAs, in the unadjusted and adjusted analyses (Cox regression models)
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Abstract
Introduction and objectives

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.

Methods

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.

Results

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.

Conclusions

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.

Keywords:
Nonvalvular atrial fibrillation
Prognosis
Stroke
Direct oral anticoagulants
Vitamin K antagonists
Abbreviations:
AF
DOAC
NVAF
VKA
Resumen
Introducción y objetivos

Comparar los resultados a largo plazo de los anticoagulantes orales directos (ACOD) frente a los antagonistas de la vitamina K (AVK) en pacientes del mundo real con fibrilación auricular no valvular (FANV) en un estudio nacional prospectivo.

Métodos

El estudio FANTASIIA incluyó consecutivamente a pacientes ambulatorios con FANV anticoagulados con ACOD o AVK desde junio de 2013 hasta octubre de 2014. Se compararon las tasas de eventos según el anticoagulante administrado.

Resultados

Se incluyó a 2.178 pacientes (edad, 73,8±9,4 años; el 43,8% mujeres); de ellos, 533 (24,5%) recibían ACOD y 1.645 (75,5%), AVK. Tras una mediana de seguimiento de 32,4 meses, los pacientes con ACOD tuvieron tasas más bajas de ictus —0,40 (IC95%, 0,17-0,97) frente a 1,07 (IC95%, 0,79-1,46) pacientes/año; p=0,032—, hemorragias mayores —2,13 (IC95%, 1,45-3,13) frente a 3,28 (IC95%, 2,75-3,93) pacientes/año; p=0,044—, muerte cardiovascular —1,20 (IC95%, 0,72-1,99) frente a 2,45 (IC95%, 2,00-3,00) pacientes/año; p=0,009— y muerte total —3,77 (IC95%, 2,83-5,01) frente a 5,54 (IC95%, 4,83-6,34) pacientes/año; p=0,016—. En el análisis de Cox modificado según el método de Andersen-Gill para datos con múltiples eventos, las razones de riesgos instantáneos para los pacientes con ACOD fueron 0,42 (0,16-1,07) para el ictus; 0,47 (0,20-1,16) para la embolia sistémica en general; 0,76 (0,50-1,15) para las hemorragias mayores; 0,67 (0,39-1,18) para la muerte cardiovascular; 0,86 (0,62-1,19) para la mortalidad total y 0,82 (0,64-1,05) para el combinado de ictus, embolias, hemorragias mayores y muerte.

Conclusiones

El tratamiento con ACOD se asocia con una tendencia a una menor tasa de todos los eventos graves, incluida la mortalidad, en relación con los AVK en pacientes con FANV en España.

Palabras clave:
Fibrilación auricular no valvular
Pronóstico
Ictus
Anticoagulantes orales directos
Antagonistas de la vitamina K

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