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Polymer-free drug-coated coronary stents in patients at high beeding Risk
Urban, Philip; Meredith, Ian T; Abizaid, Alexandre; Pocock, Stuart J; Carrié, Didier; Naber, Christoph; Lipiecki, Janusz; Richardt, Gert; Iñiguez, Andres; Brunel, Philippe; Valdes-Chavarri, Mariano; Garot, Philippe; Talwar, Suneel; Berland, Jacques; Abdellaoui, Mohamed; Eberli, Franz; Oldroyd, Keith; Zambahari, Robaayah; Gregson, John; Greene, Samantha; Stoll, Hans-Peter; Morice, Marie-Claude.
Afiliação
  • Urban, Philip; Hôpital de la Tour. Geneva. CH
  • Meredith, Ian T; MonashHeart and Monash University. Melbourne. AU
  • Abizaid, Alexandre; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
  • Pocock, Stuart J; London School of Hygiene and Tropical Medicine. London. GB
  • Carrié, Didier; Toulouse Rangueil Hospital. Toulouse. FR
  • Naber, Christoph; Contilia Heart and Vascular Center, Elisabeth Krankenhaus. Essen. DE
  • Lipiecki, Janusz; Pôle Santé République. Clermont-Ferrand. FR
  • Richardt, Gert; Herzzentrum Segeberger Kliniken. Bad Segeberg. DE
  • Iñiguez, Andres; Complejo Hospital Meixoeiro. Vigo. ES
  • Brunel, Philippe; Clinique de la Fontaine. Dijon. FR
  • Valdes-Chavarri, Mariano; Arrixaca University Hospital. Murcia. ES
  • Garot, Philippe; Hôpital Claude Galien, Institut Cardiovasculaire Paris Sud (ICPS), Gé-nérale de Santé. Quincy-sous-Sénart. FR
  • Talwar, Suneel; The Dorset Heart Centre Royal Bournemouth Hospital. Bournemouth. GB
  • Berland, Jacques; Clinique Saint Hilaire. Rouen. FR
  • Abdellaoui, Mohamed; Groupe Hospitalier Mutualiste de Grenoble. Grenoble. FR
  • Eberli, Franz; Triemli Hospital. Zurich. CH
  • Oldroyd, Keith; West of Scotland Regional Heart and Lung Centre Golden Jubilee National Hospital. Glasgow. GB
  • Zambahari, Robaayah; The Institute Jantung Negara. Kuala Lumpur. MY
  • Gregson, John; London School of Hygiene and Tropical Medicine. London. GB
  • Greene, Samantha; Biosensors Europe. Morge. CH
  • Stoll, Hans-Peter; Biosensors Europe. Morge. CH
  • Morice, Marie-Claude; ICPS, Générale de Santé. Massy. FR
N Engl J Med ; 373(21): 2038-2047, 2015. tab
Article em En | SES-SP, SESSP-IDPCPROD, SES-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)...
Assuntos
Texto completo: 1 Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Stents / Intervenção Coronária Percutânea Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Idioma: En Revista: N Engl J Med Ano de publicação: 2015 Tipo de documento: Article
Texto completo: 1 Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Stents / Intervenção Coronária Percutânea Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Idioma: En Revista: N Engl J Med Ano de publicação: 2015 Tipo de documento: Article