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Master Thesis

Utilisation des bases médico-administratives dans la surveillance des effets indésirables : patients porteurs d’une fibrillation auriculaire et dabigatran

Abstract : Background : Atrial fibrillation (AF) requires thromboembolic prevention with vitamin K antagonists (VKA) or a new oral anticoagulant such as dabigatran, which is as effective and easier to use. Concerns have been raised about an increased risk of myocardial infarction (MI). The aim of this study was to describe cardiovascular diseases in a population-based cohort of AF patients using the French National Health Insurance System (NHIS) and more specifically, the risk of MI in anticoagulant-naïve patients treated with dabigatran. Methods : Data from the French NHIS database was used to form a population-based cohort and included patients receiving a first anticoagulant treatment for thromboembolic prevention in AF or with an ICD-10 code for AF in 2011 or 2012, patients were followed until the end of 2012 or death. We used a nested case-control analysis. Cases were patients with a first MI and were matched with controls with a risk set sampling, according to age, gender, HAS-BLED score and the date of cohort entry. We used an adjusted conditional logistic regression. Results : A cohort of 158,630 patients treated by dabigatran or VKA or with a ICD-10 I48 code was constructed. The incidence density rate for heart failure, the most frequent cardiovascular disease was 55.4 for 1,000 personyears. The nested case control study included 71,118 patients treated by dabigatran or VKA. Among those, 232 cases with a first MI were selected and matched to 2,293 controls. Use of dabigatran in the last 30 days was associated with an increased risk of MI (adjusted RR=1.60; 95%CI [0.96-2.67]). Conclusion : Using the French NHIS database, a population-based cohort of patients with AF was constructed and incidence density rates for cardiovascular diseases were estimated. Dabigatran is associated with an increased risk of MI in patients with AF treated with dabigatran.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01111372
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Submitted on : Friday, January 30, 2015 - 11:31:52 AM
Last modification on : Wednesday, August 23, 2017 - 4:32:31 PM
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Amélie Beaugrand. Utilisation des bases médico-administratives dans la surveillance des effets indésirables : patients porteurs d’une fibrillation auriculaire et dabigatran. Médecine humaine et pathologie. 2014. ⟨dumas-01111372⟩

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