ASSESSMENT OF CAROTID STENTING SAFETY- A FRENCH EXHAUSTIVE COHORT STUDY BASED ON THE RE-USE OF ROUTINE NATIONAL HEALTH DATABASE
Author(s)
Marque S1, Beyssen B2, Congard-Chassol B3, Levesque K4, Nguyen T5, Mouton E6, Collignon C7, Chatellier G2
1EXEPI, Paris, France, 2HEGP, Paris, France, 3SNITEM, Levallois, France, 4Capionis, Bordeaux, France, 5Johnson & Johnson Medical Devices, ISSY-LES-MOULINEAUX, France, 6Boston Scientific, Nanterre, France, 7Medtronic, Boulogne, France
OBJECTIVES: Following the requirements of the French Health Technology Assessment Agency (HAS), a real-world study has been conducted in order to assess the safety of carotid stenting (CS) in France among patients with or without neurological symptoms (stroke, TIA). It was the first French post-reimbursement study using routine health data on medical devices, with reinscription stakes for 6 devices from 4 companies. METHODS: Data of this 3-year observational cohort study were extracted from the French national health insurance database (SNIIRAM) linked with data from the French national hospital discharge database (PMSI). Both contain exhaustive data on all reimbursements for health related expenditures, including medical devices, procedure codes (CCAM) and discharge diagnoses (ICD-10). The end points were a composite of stroke and death occurring within 30 days (primary) and within 1 year (secondary) after CS. Sub-groups analyses were planned according to age, stenting volume of the center and asymptomatic vs. symptomatic stenosis. RESULTS: Between 2011/01/01 and 2013/11/30, 2071 patients in 161 hospitals (50% public) underwent a CS procedure (18% for a symptomatic stenosis). Among the whole population, the 30-day and the 1-year incidence of stroke and death were 5.2% and 11.0%, respectively. At 30d, this incidence was largely greater in symptomatic (18.1%) vs. asymptomatic (2.3%) patients. Incidence of stroke and death was similar in young and old patients (threshold: 70 years) and in centers with low or high carotid stenting activity (threshold: 10 yearly procedures). CONCLUSIONS: 1/ Our results show that CS is rarely performed in France, according to results of randomized trials and HAS recommendations; 2/ In this selected population, CS carries a low risk of complications except in patients with carotid thrombus; 3/ The re-use of routine health data allows getting robust indicators on a consecutive and exhaustive population at relatively low costs and efforts.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PMD13
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Cardiovascular Disorders