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A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial
Scheller, Bruno; Fontaine, Tobias; Norman, Mangner; Hoffmann, Stefan; Bonaventura, Klaus; Clever, Yvonne P; Chamie, Daniel; Costa, Ribamar; Gershony, Gary; Kelsch, Bettina; Kutschera, Maren; Genereux, Philippe; Cremers, Bodo; Bohm, Michael; Speck, Ulrich; Abizaid, Alexandre.
Afiliación
  • Scheller, Bruno; Universitätsklinikum des Saarlandes. Homburg. DE
  • Fontaine, Tobias; Universitätsklinikum des Saarlandes. Homburg. DE
  • Norman, Mangner; Leipzig, Herzzentrum. DE
  • Hoffmann, Stefan; Werner Forßmann Krankenhaus. Eberswalde. DE
  • Bonaventura, Klaus; Ernst Von Bergmann Klinikum. Potsdam. DE
  • Clever, Yvonne P; Universitätsklinikum des Saarlandes. Homburg. DE
  • Chamie, Daniel; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
  • Costa, Ribamar; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
  • Gershony, Gary; John Muir Cardiovascular Institute. Concord. US
  • Kelsch, Bettina; Experimentelle Radiologie. Berlin. DE
  • Kutschera, Maren; Experimentelle Radiologie. Berlin. DE
  • Genereux, Philippe; Columbia University and Cardiovascular Research Foundation. US
  • Cremers, Bodo; Universitätsklinikum des Saarlandes. Homburg. DE
  • Bohm, Michael; Universitätsklinikum des Saarlandes. Homburg. DE
  • Speck, Ulrich; Experimentelle Radiologie. Berlin. DE
  • Abizaid, Alexandre; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
Catheter Cardiovasc Interv ; 88(1): 51-59, 2016. ilus, tab, graf
Article en En | SES-SP, SESSP-IDPCPROD, SES-SP | ID: biblio-1061852
Biblioteca responsable: BR79.1
Ubicación: BR79.1
ABSTRACT
Scoring balloons produce excellent acute results in the treatment of instentrestenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown toaffect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developedand tested to overcome this limitation. Methods and

Results:

SB were coatedwith paclitaxel admixed with a specific excipient. Patients at four clinical sites inGermany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized11 to treatment with either a drug-coated or uncoated SB. Baseline and 6-monthfollow-up quantitative coronary angiography was performed by an independent blindedcore lab and all patients will be evaluated clinically for up to one year. The primaryendpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite ofmajor adverse cardiovascular events (MACE), stent thrombosis and other variables.Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, insegmentLLL was 0.48 6 0.51 mm in the uncoated SB group versus 0.17 6 0.40 mm inthe drug-coated SB group (P 5 0.01; ITT analysis). The rate of binary restenosis was41% in the uncoated SB group versus 7% in the drug-coated SB group (P 5 0.004). TheMACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group(P 5 0.016). This difference was primarily due to the reduced need for clinically drivenTLR in the coated SB group (3% vs. 32% P 5 0.004).

Conclusions:

A novel paclitaxelcoatedcoronary SB has been developed and successfully used in a first-in-human randomized controlled trial...
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Colección: 06-national / BR Base de datos: SES-SP / SESSP-IDPCPROD Asunto principal: Enfermedad Coronaria / Difusión de Innovaciones Tipo de estudio: Clinical_trials / Sysrev_observational_studies Idioma: En Revista: Catheter Cardiovasc Interv Año: 2016 Tipo del documento: Article
Buscar en Google
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Colección: 06-national / BR Base de datos: SES-SP / SESSP-IDPCPROD Asunto principal: Enfermedad Coronaria / Difusión de Innovaciones Tipo de estudio: Clinical_trials / Sysrev_observational_studies Idioma: En Revista: Catheter Cardiovasc Interv Año: 2016 Tipo del documento: Article