With the introduction of the New Oral Anticoagulants (NOACs) in the Netherlands for the indication non-valvular atrial fibrillation questions rose concerning the safety, efficacy and cost-effectiveness of these new drugs in daily practice (see Health Council report 2012).
To address these questions we plan to use claim data of all Dutch health insurance companies. These claim data are collected in one central database, which is managed by Vektis (a company owned by the combined health insurance companies). This database contains all insured extra-mural medication transcriptions and all diagnoses for which medical care is claimed by hospitals. This data base can be used as a cohort study of vitamin K antagonists (VKA) and NOACs users for the indication non-valvular AF with follow-up data on the main complications, including ischemic stroke, intracerebral and intracranial bleeding, and extracranial major bleeding.
First we like to validate this dataset by answering three questions:
-How many patients were diagnosed with non-valvular AF and used a VKA in the period January 1st and December 31st 2010, stratified for age and sex?
-What was the incidence of ischemic stroke, TIA, intracerebral as well as intracranial and gastrointestinal haemorrhages?
-What is the total amount of claimed Health care costs during use of a VKA for non-valvular AF?
The results will be compared with data from other sources like the Federation of Dutch Thrombosis Services, data from the clinical trials and medical literature.
If these data match we will decide whether we can validly use the Vektis data base for the above mentioned purpose or whether a second pilot study with matching on an individual basis is needed.