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Long-Term Follow-up and Mortality Rate of Patients of the Randomized Freeway Stent Study.
Hausegger, Klaus; Kurre, Wiebke; Schröder, Henrik; Dambach, Johannes; Stahnke, Stefanie; Loewe, Christian; Schürmann, Karl; Fischbach, Roman; Textor, Jochen; Schäfer, Stephan; Müller-Hülsbeck, Stephan.
Afiliación
  • Hausegger K; Institut Für Diagnostische und Interventionelle Radiologie, Klinikum Klagenfurt am Wörthersee, Feschnigstraße 11, 9020, Klagenfurt, Austria. cvir.hausegger@outlook.com.
  • Kurre W; Institut Für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Klinikum Passau, Innstraße 76, 94036, Passau, Germany.
  • Schröder H; Gemeinschaftspraxis für Radiologie, Neuroradiologie & Zentrum für Minimal Invasive, Therapie am Jüdischen Krankenhaus Berlin, Heinz-Galinski-Str. 1, 13347, Berlin, Germany.
  • Dambach J; Eurocor Tech GmbH, In den Dauen 6a, 53117, Bonn, Germany.
  • Stahnke S; Eurocor Tech GmbH, In den Dauen 6a, 53117, Bonn, Germany.
  • Loewe C; Kardiovaskuläre und Interventionelle Radiologie, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Vienna, Austria.
  • Schürmann K; Institut für Diagnostische, Interventionelle Radiologie St.-Johannes-Hospital Dortmund, Johannesstraße 9-17, 44137, Dortmund, Germany.
  • Fischbach R; Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinik Altona, Paul-Ehrlich-Str. 1, 22763, Hamburg, Germany.
  • Textor J; Abteilung für Radiologie Gemeinschaftskrankenhaus Bonn, St. Elisabeth/St. Petrus/St. Johannes gGmbH, Bonner Talweg 4-6, 53113, Bonn, Germany.
  • Schäfer S; Klinik für Diagnostische und Interventionelle Radiologie, Klinikum St. Elisabeth Straubing GmbH, St.-Elisabeth-Str. 23, 94315, Straubing, Germany.
  • Müller-Hülsbeck S; Institut Für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Diakonissenkrankenhaus Flensburg, Knuthstraße 1, 24939, Flensburg, Germany.
Cardiovasc Intervent Radiol ; 47(2): 186-193, 2024 Feb.
Article en En | MEDLINE | ID: mdl-38273128
ABSTRACT

PURPOSE:

This follow-up study was designed as a reopen of the completed Freeway Stent Study and collected mortality and clinical outcome data for at least 5 years after enrollment to evaluate long-term patient safety and treatment efficacy. The primary study enrolled 204 patients with stenosis or occlusion in the superficial femoral artery and proximal popliteal artery. Patients were randomized to primary nitinol stenting followed by standard PTA or primary nitinol stenting followed by FREEWAY™ paclitaxel-eluting balloon PTA.

METHODS:

Previous patients were recontacted by phone or during a routine hospital visit, and medical records were reviewed. Vital and clinical status information was collected.

RESULTS:

No increased late mortality was observed at 5 years, with an all-cause mortality rate of 12.0% in the FREEWAY drug-eluting balloon group versus 15.0% in the non-paclitaxel PTA group. No accumulation of any cause of death was observed in either group, nor was there any correlation with the dose of paclitaxel used. Freedom from clinically driven target lesion revascularization at 5 years was significantly higher in the FREEWAY drug eluting balloon group (85.3%) compared to standard PTA group (72.7%) Log-rank p = 0.032.

CONCLUSION:

The safety results presented support the recent conclusions that the use of paclitaxel technology does not lead to an increase in mortality. At the same time, the efficacy results clearly demonstrate that the potential benefits of drug-eluting balloon treatment are maintained over a 5-year period.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Angioplastia de Balón / Aleaciones / Enfermedad Arterial Periférica Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Cardiovasc Intervent Radiol Año: 2024 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Estados Unidos
Texto completo
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Imprimir
XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Angioplastia de Balón / Aleaciones / Enfermedad Arterial Periférica Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Cardiovasc Intervent Radiol Año: 2024 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Estados Unidos