Risk of stroke and other cardiovascular events among warfarin-treated atrial fibrillation patients – a nationwide cohort study in Finland (FinWAF)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  WARFARIN
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  All atrial fibrillation patients using warfarin with INR measurements in selected hospital district areas in Finland between 01-Jan-2007 and 31-Dec-2009.; Patients who have purchased warfarin (ATC code B01AA03) between 01-Jan-2007 and 31-Dec-2009, have at least one INR measurement between 01-Jan-2007 and 31-Dec-2009, and have ICD-10 diagnosis I48 for AF between 01-Jan-2005 and 31-Dec-2009 were included.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with atrial fibrillation
• Estimated number of subjects:
  32000

Study design details

• Main study objective:
  To investigate and compare risk of stroke, systemic thromboembolism, myocardial infarction, bleeding events and mortality among atrial fibrillation patients in relation to International Normalized Ratio levels: under 2.0, 2.0-3.0, and over 3.0.
• Outcomes:
  Stroke, Other systemic thromboembolic events excluding stroke, Myocardial infarction, Bleeding events, Mortality (all-cause), Mortality (stroke), Mortality (myocardial infarction), Mortality (systemic thromboembolic events excluding stroke), Mortality (bleeding events), anemia and renal impairment
• Data analysis plan:
  Stratified incidence rates with 95% CIs will be estimated for each endpoint within the strata of the INR levels, time in therapeutic INR range (TTR) categories, and other covariates.The crude and adjusted hazard ratio (HR) estimates with 95% CIs and P-values will be estimated within the INR levels and TTR categories using the conventional Cox’s proportional hazards model adjusting for other covariates. For INR the category 2.0–3.0 will be used as the reference category. Similarly for TTR the category ≥ 60% of time will be used as the reference category.

Documents

Study results

ER 9441_ENCePP_study report synopsis_20160624

Study publications

Lehto M, Niiranen J, Korhonen P, Mehtälä J, Khanfir H, Hoti F, Lassila R, Raati…

Lehto M, Niiranen J, Korhonen P, Mehtälä J, Khanfir H, Hoti F, Lassila R, Raati…

Raatikainen P, Niiranen J, Korhonen P, Mehtälä J, Khanfir H, Lassila R, Lehto M…