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Major ischaemic and bleeding risks following current drug-eluting stent implantation: Are there differences across current drug-eluting stent types in real life?
Schapiro-Dufour, Emmanuelle; Tricotel, Aurore; Slama, Michel S; Ducimetière, Pierre; Trinh-Duc, Albert; Sichel, Claude; Le Tri, Thien; Galmiche, Hubert; Dray-Spira, Rosemary; Zureik, Mahmoud.
Afiliação
  • Schapiro-Dufour E; Medical Devices Department, French National Authority for Health (HAS), 93210 Saint-Denis, France. Electronic address: emmanuelle.dufour@ansm.sante.fr.
  • Tricotel A; 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.
  • Slama MS; Cardiology Department, CHU Xavier Bichat, 75877 Paris, France; Faculty of Medicine, Paris Sud-XI University, 94270 Le Kremlin-Bicêtre, France.
  • Ducimetière P; Inserm, Paris Sud-XI University, 94800 Villejuif, France.
  • Trinh-Duc A; Emergency Department, Centre Hospitalier Saint-Esprit, 47923 Agen, France.
  • Sichel C; 13470 Carnoux En Provence, France.
  • Le Tri T; 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.
  • Galmiche H; Medical Devices Department, French National Authority for Health (HAS), 93210 Saint-Denis, France.
  • Dray-Spira R; 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.
  • Zureik M; 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; Versailles-Saint-Quentin-en-Yvelines University, 78000 Versailles, France.
Arch Cardiovasc Dis ; 112(8-9): 469-484, 2019.
Article em En | MEDLINE | ID: mdl-31262635
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doença da Artéria Coronariana / Trombose Coronária / Inibidores da Agregação Plaquetária / Stents Farmacológicos / Intervenção Coronária Percutânea / Hemorragia Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doença da Artéria Coronariana / Trombose Coronária / Inibidores da Agregação Plaquetária / Stents Farmacológicos / Intervenção Coronária Percutânea / Hemorragia Idioma: En Ano de publicação: 2019 Tipo de documento: Article