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Six-month results of the NEVO RES-ELUTION I (NEVO RES-I) trial: randomized, multicenter comparison of the NEVO Sirolimus-Eluting coronary stent vith the TAXUS libert paclitaxel-eluting stent in de novo native coronary artery lesions
Ormiston, John A; Abizaid, Alexandre; Spertus, John; Fajadet, Jean; Mauri, Laura; Schofer, Joachim; Verheye, Stefan; Dens, Joseph; Thuesen, Leif; Dubois, Christophe; Hoffmann, Rainer; Wijns, William; Fitzgerald, Peter J; Popma, Jeffrey J; Nathalie Macours; Cebrian, Ana; Stoll, Hans-Peter; Rogers, Campbell; Spaulding, Christian.
Afiliação
  • Ormiston, John A; The North Shore Hospital. Auckland. NZ
  • Abizaid, Alexandre; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
  • Spertus, John; St Luke’s Hospital. Kansas City. US
  • Fajadet, Jean; Clinique Pasteur. Toulouse. FR
  • Mauri, Laura; Brigham and Women’s Hospital. Boston. US
  • Schofer, Joachim; Herzkatheterlabor und Praxisklinik. Hamburg. DE
  • Verheye, Stefan; Middelheim Hospital. Antwerp. BE
  • Dens, Joseph; Ziekenhuis Oost-Limburg. Genk. BE
  • Thuesen, Leif; Skejby Sygehuy. Aarhus. DK
  • Dubois, Christophe; University Hospital. Leuven. BE
  • Hoffmann, Rainer; University Hospital. Aachen. DE
  • Wijns, William; Onze-Lieve-Vrouweziekenhuis. Aalst. BE
  • Fitzgerald, Peter J; Stanford University School of Medicine. Stanford. US
  • Popma, Jeffrey J; Beth Israel Deaconess Medical Center. Boston. US
  • Nathalie Macours; Cordis Clinical Research. Waterloo. BE
  • Cebrian, Ana; Cordis Clinical Research. Waterloo. BE
  • Stoll, Hans-Peter; Cordis Clinical Research. Waterloo. BE
  • Rogers, Campbell; Cordis Clinical Research. Waterloo. BE
  • Spaulding, Christian; Paris Descartes University. Paris. FR
Circ Cardiovasc Interv ; 3(6): 556-564, 2010. ilus, tab
Article em En | SES-SP, SESSP-IDPCPROD, SES-SP | ID: biblio-1061961
Biblioteca responsável: BR79.1
Localização: BR79.1
ABSTRACT
Background—Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis,which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs withbioabsorbable polymer to reduce spatial and temporal polymer exposure.Methods and Results—NEVO ResElution-I was a prospective randomized study in 394 patients with coronary arterydisease comparing the NEVO SES with the TAXUS Liberte´ paclitaxel-eluting coronary stent (TAXUS Liberte´ PES)stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronaryintervention (PCI), the primary end point favored NEVO SES (0.13 0.31 mm versus 0.36 0.48 mm, P 0.001 fornoninferiority and superiority). The study was not powered for clinical end points and showed no significant differencefor NEVO SES versus TAXUS Liberte´ PES death 0.5 versus 1.6%, P 0.36; myocardial infarction 2.0 versus 2.6%,P 0.75; target lesion revascularization 1.5 versus 3.2%, P 0.33; major adverse cardiac events 4.0 versus 7.4%, P 0.19.No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberte´ PES. Intravascularultrasound showed lower percent volume obstruction for NEVO SES (5.5 11% versus 11.5 9.7%, P 0.016).Conclusions—This trial proved the superiority of NEVO SES over TAXUS Liberte´ PES for the primary angiographic endpoint of in-stent late loss. No stent thrombosis occurred in the NEVO SES group.
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Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Stents / Angioplastia / Reestenose Coronária Tipo de estudo: Clinical_trials Idioma: En Revista: Circ Cardiovasc Interv Ano de publicação: 2010 Tipo de documento: Article
Buscar no Google
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Coleções: 06-national / BR Base de dados: SES-SP / SESSP-IDPCPROD Assunto principal: Stents / Angioplastia / Reestenose Coronária Tipo de estudo: Clinical_trials Idioma: En Revista: Circ Cardiovasc Interv Ano de publicação: 2010 Tipo de documento: Article