Net clinical benefit of vitamin K antagonists versus direct oral anticoagulants for nonvalvular atrial fibrillation

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103473
• EU PAS number:
  EUPAS103472
• Study ID:
  103473
• Official title and acronym:
  Net clinical benefit of vitamin K antagonists versus direct oral anticoagulants for nonvalvular atrial fibrillation
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  AIM: to assess the net clinical benefit (combined risk of suffering acute non-fatal atherothrombotic events, major bleeding or death) asociated with the exposure of vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) in patients with nonvalvular atrial fibrillation (NVAF). DESIGN: retrospective cohort study based on the information provided by BIFAP (Database for Pharmacoepidemiological Research in Primary Care). Subjects: adults with NVAF and at least one prescription of VKA and/or DOAC between 2010 and 2021. Primary composite outcome: risk of suffering acute non-fatal atherothrombotic events, major bleeding or death with VKA or DOAC. Primary safety outcome: risk of suffering major bleeding. Secondary result outcomes: risk of primary outcome combined for each active principle. Risk of each individual component of the composite primary outcome. DATA ANALYSIS: 1. Primary outcome incidences per 1000 person-years by sex and age group. 2. Outcome analysis through multilevel survival models. 3. Outcome analysis by subgroups: >74 years, naïve to anticoagulants, secondary prevention, chronic renal failure. 4. Sensitivity analysis of the primary composite outcome by: time of exposition to the anticoagulant, diary dosis of DOAC, level of effective anticoagulation with VKA, ischaemic and bleeding risk. 5. Analysis of the primary composite outcome for edoxaban by renal function. 6. Sensitivity analysis of major bleeding excluding traumatic major bleedings.
• Study status:
  Planned

Research institutions and networks

Institutions

Servicio Navarro de Salud-Osasunbidea

Spain

Study timelines

Date when funding contract was signed

Planned: 01/01/2023

Study start date

Planned: 01/03/2023

Date of final study report

Planned: 01/03/2024

Sources of funding

Other

More details on funding

Government of Navarre

Study protocol

Initial protocol

Memoria NACOs BIFAP v4. 06-05-2022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable