Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study

Rev Esp Cardiol (Engl Ed). 2020 Jan;73(1):14-20. doi: 10.1016/j.rec.2019.02.021. Epub 2019 May 31.
[Article in English, Spanish]

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: Antagonistas de la vitamina K; Anticoagulantes orales directos; Direct oral anticoagulants; Fibrilación auricular no valvular; Ictus; Nonvalvular atrial fibrillation; Prognosis; Pronóstico; Stroke; Vitamin K antagonists.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study

MeSH terms

  • Administration, Oral
  • Aged
  • Anticoagulants / administration & dosage*
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / drug therapy*
  • Cause of Death / trends
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Outpatients
  • Prognosis
  • Prospective Studies
  • Spain / epidemiology
  • Stroke / epidemiology
  • Stroke / etiology
  • Stroke / prevention & control*
  • Survival Rate / trends
  • Time Factors
  • Vitamin K / antagonists & inhibitors*

Substances

  • Anticoagulants
  • Vitamin K