Polymer-free drug-coated coronary stents in patients at high beeding Risk
N Engl J Med
; 373(21): 2038-2047, 2015. tab
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1064857
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
BACKGROUND:
Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.METHODS:
In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.RESULTS:
We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001)...
Texto completo:
Disponível
Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Stents
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Intervenção Coronária Percutânea
Tipo de estudo:
Ensaio clínico controlado
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Estudo de etiologia
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Fatores de risco
Idioma:
Inglês
Revista:
N Engl J Med
Ano de publicação:
2015
Tipo de documento:
Artigo
Instituição/País de afiliação:
Arrixaca University Hospital/ES
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Biosensors Europe/CH
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Clinique Saint Hilaire/FR
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Clinique de la Fontaine/FR
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Complejo Hospital Meixoeiro/ES
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Contilia Heart and Vascular Center, Elisabeth Krankenhaus/DE
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Groupe Hospitalier Mutualiste de Grenoble/FR
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Herzzentrum Segeberger Kliniken/DE
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Hôpital Claude Galien, Institut Cardiovasculaire Paris Sud (ICPS), Gé-nérale de Santé/FR
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Hôpital de la Tour/CH