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Archives of cardiovascular diseases
Volume 112, n° 8-9
pages 469-484 (août 2019)
Doi : 10.1016/j.acvd.2019.04.007
Received : 26 February 2019 ;  accepted : 2 April 2019
Clinical research

Major ischaemic and bleeding risks following current drug-eluting stent implantation: Are there differences across current drug-eluting stent types in real life?
Risques ischémiques et hémorragiques après pose de stents coronaires : y a t-il des différences en vie réelle entre les types de stents actifs ?
 

Emmanuelle Schapiro-Dufour a, , Aurore Tricotel b, Michel S. Slama c, d, Pierre Ducimetière e, Albert Trinh-Duc f, Claude Sichel g, Thien Le Tri b, Hubert Galmiche a, Rosemary Dray-Spira b, Mahmoud Zureik b, h
a Medical Devices Department, French National Authority for Health (HAS), 93210 Saint-Denis, France 
b Epidemiology of Health Products (EPI-PHARE), French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), 93285 Saint-Denis, France 
c Cardiology Department, CHU Xavier Bichat, 75877 Paris, France 
d Faculty of Medicine, Paris Sud-XI University, 94270 Le Kremlin-Bicêtre, France 
e Inserm, Paris Sud-XI University, 94800 Villejuif, France 
f Emergency Department, Centre Hospitalier Saint-Esprit, 47923 Agen, France 
g 13470 Carnoux En Provence, France 
h Versailles-Saint-Quentin-en-Yvelines University, 78000 Versailles, France 

Corresponding author. Epidemiology of Health Products (EPI-PHARE), French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), 42, boulevard de la Libération, 93285 Saint-Denis, France.Epidemiology of Health Products (EPI-PHARE), French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM)42, boulevard de la LibérationSaint-Denis93285France
Summary
Background

Current drug-eluting stents (c-DESs) reduce the occurrence of ischaemic events, but expose recipients to stent thrombosis and bleeding secondary to preventive antiplatelet therapy. To date, comparative data on the relative effectiveness and safety of the various c-DESs in real life are limited.

Aim

To compare ischaemic and bleeding risks across the major c-DESs used in France.

Methods

French national health insurance reimbursement and hospitalization databases were used. Patients implanted with a c-DES in 2014 were followed for 1 year. The risks of ischaemic events (revascularization, myocardial infarction and/or stroke), major bleeding events and death were compared across six c-DESs (XIENCE®, PROMUS®, RESOLUTE®, BIOMATRIX®, NOBORI® and ORSIRO®), using multilevel Cox models adjusted for baseline individual and hospital characteristics.

Results

A total of 52,891 subjects were included: 34.4% with XIENCE®; 27.6% with PROMUS®; 24.0% with RESOLUTE®; 8.0% with BIOMATRIX®; 5.0% with NOBORI®; and 1.0% with ORSIRO®. Among them, 9378 had at least one event (ischaemic, 6064; major bleeding, 1968; death, 2411), resulting in an overall incidence rate of 19 per 100 person-years. In the multivariable analysis, the risk of ischaemic events, major bleeding events or death did not differ between the c-DESs overall (adjusted hazard ratios between 0.85 [95% confidence interval 0.68–1.07] and 1.04 [95% confidence interval 0.98–1.10] compared with XIENCE® used as the reference) and when each outcome was considered separately.

Conclusions

In real life, major ischaemic and bleeding risks do not differ across the various c-DESs over the first year following implantation. Future studies are needed to assess comparative c-DES effectiveness and safety longer term.

The full text of this article is available in PDF format.
Résumé
Contexte

Les stents actifs (DES) diminuent la survenue d’évènements ischémiques, mais peuvent entraîner des thromboses et des hémorragies secondaires au traitement antiagrégant plaquettaire. Les données d’efficacité et de sécurité comparant les DES en vie réelle sont limitées.

Objectif

Cette étude avait pour objectif de comparer les risques ischémiques et hémorragiques entre les DES couramment utilisés dans la pratique française.

Méthodes

Les données utilisées sont issues du Système national des données de santé. Les patients implantés de DES en 2014 ont été suivis pendant un an. Les risques d’évènements ischémiques (regroupant nouvelle revascularisation, infarctus du myocarde et/ou accident vasculaire cérébral), d’évènements hémorragiques majeurs et de décès ont été comparés entre XIENCE®, PROMUS®, RESOLUTE®, BIOMATRIX®, NOBORI® et ORSIRO®, à l’aide d’un modèle de Cox multiniveaux ajusté sur les caractéristiques des patients et des centres implanteurs à l’inclusion.

Résultats

Au total, 52 891 patients étaient inclus : 34,4 % recevaient XIENCE® ; 27,6 % PROMUS® ; 24,0 % RESOLUTE® ; 8,0 % BIOMATRIX® ; 5,0 % NOBORI® ; et 1,0 % ORSIRO®. Parmi eux, 9378 présentaient au moins un évènement (ischémique, 6064 ; hémorragique, 1968 ; décès, 2411), avec une incidence de 19 pour 100 personnes-années. En analyse multivariée, le risque global ne différait entre les DES (HRs ajusté entre 0,85 [IC 95 % 0,68–1,07] et 1,04 [IC 95 % 0,98–1,10] comparé à XIENCE®) et également pour chaque évènement considéré séparément.

Conclusions

En vie réelle, les risques ischémiques et hémorragiques ne diffèrent pas entre les DES jusqu’à un an après l’implantation. D’autres études en pratique clinique sont nécessaires pour comparer l’efficacité et la sécurité à long terme entre les DES.

The full text of this article is available in PDF format.

Keywords : Drug-eluting stents, Ischaemic risks, Major bleeding risks, Real life, French National Health Insurance Claims database

Mots clés : Stents actifs, Risques ischémiques, Risques hémorragiques majeurs, Pratique clinique, Système national des données de santé (SNDS)

Abbreviations : c-DES, CI, DAPT, DES, HR, ICD-10, PCI, RCT, SNDS




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