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1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass.
Reijnen, Michel M P J; van Walraven, Laurens A; Fritschy, Wilbert M; Lensvelt, Mare M A; Zeebregts, Clark J; Lemson, M Suzanna; Wikkeling, Otmar R M; Smeets, Luuk; Holewijn, Suzanne.
Afiliación
  • Reijnen MMPJ; Department of Surgery, Rijnstate, Arnhem, the Netherlands. Electronic address: mmpj.reijnen@gmail.com.
  • van Walraven LA; Department of Surgery, Antonius Hospital, Sneek, the Netherlands.
  • Fritschy WM; Department of Vascular Surgery, Isala, Zwolle, the Netherlands.
  • Lensvelt MMA; Department of Surgery, Rijnstate, Arnhem, the Netherlands.
  • Zeebregts CJ; Department of Surgery, Division of Vascular Surgery, University of Groningen, Groningen, the Netherlands.
  • Lemson MS; Department of Surgery, Slingeland Hospital, Doetinchem, the Netherlands.
  • Wikkeling ORM; Department of Surgery, Nij Smellinghe Hospital, Drachten, the Netherlands.
  • Smeets L; Department of Surgery, Rijnstate, Arnhem, the Netherlands.
  • Holewijn S; Department of Surgery, Rijnstate, Arnhem, the Netherlands.
JACC Cardiovasc Interv ; 10(22): 2320-2331, 2017 11 27.
Article en En | MEDLINE | ID: mdl-29169500
OBJECTIVES: This study sought to compare heparin-bonded endografts with femoropopliteal bypass, including quality of life, using general health and disease-specific questionnaires as well as patency rates. BACKGROUND: Endovascular treatment continues to advance and is gaining acceptance as primary treatment for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene endografts have been related to outcomes comparable to bypass surgery, but this has not been tested in a randomized fashion. METHODS: A multicenter randomized-controlled trial was performed comparing femoropopliteal bypass with heparin-bonded expanded polytetrafluoroethylene endografts. Data were analyzed on an intention-to-treat and per-protocol manner. RESULTS: A total of 129 patients were randomized and 125 patients were treated, 63 in the endoluminal and 62 in the surgical group (42 venous, 20 prosthetic). Enrollment was terminated before reaching the predefined target number for patency. Baseline characteristics and anatomical data were similar. Patients were treated for critical limb ischemia in 38.1% and 32.2% in the endoluminal and surgical arms, respectively. Mean lesion length was 23 cm in both groups and lesions were largely TransAtlantic Inter-Society Consensus II D. Hospitalization time and 30-day morbidity were significantly lower in the endoluminal group, without differences in serious adverse events (n = 5 each; surgical: 4 venous and 1 polytetrafluoroethylene bypass). There were no significant differences in Rutherford category between groups at any time point. At 30 days the endoluminal group showed a greater improvement in quality-of-life scores. At 1 year, these differences had largely disappeared and no differences in primary (endoluminal: 64.8%; surgical: 63.6%), assisted primary (endoluminal: 78.1%; surgical: 79.8%), secondary patency (endoluminal: 85.9%; surgical: 83.3%), and target vessel revascularization (endoluminal: 72.1%; surgical: 71.0%) were observed. Limb salvage rate was 100% in both groups. CONCLUSIONS: Heparin-bonded endoluminal bypass for long segment lesions shows promising results (less morbidity, faster recovery, and improvement in quality of life with indistinguishable patency rates at 1 year) compared with surgical bypass. Long-term results have to be awaited.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Arteria Poplítea / Prótesis Vascular / Heparina / Implantación de Prótesis Vascular / Materiales Biocompatibles Revestidos / Arteria Femoral / Enfermedad Arterial Periférica / Procedimientos Endovasculares / Anticoagulantes Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: JACC Cardiovasc Interv Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2017 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Arteria Poplítea / Prótesis Vascular / Heparina / Implantación de Prótesis Vascular / Materiales Biocompatibles Revestidos / Arteria Femoral / Enfermedad Arterial Periférica / Procedimientos Endovasculares / Anticoagulantes Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: JACC Cardiovasc Interv Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2017 Tipo del documento: Article Pais de publicación: Estados Unidos