1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass

摘要: Abstract 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 patency rates. Background Endovascular treatment continues advance is gaining acceptance primary for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene have been related outcomes comparable bypass surgery, but this has not tested a randomized fashion. Methods A multicenter randomized-controlled trial was performed comparing endografts. Data were analyzed on an intention-to-treat per-protocol manner. Results total 129 patients 125 treated, 63 endoluminal 62 surgical group (42 venous, 20 prosthetic). Enrollment terminated before reaching predefined target number patency. Baseline characteristics anatomical data similar. Patients treated critical limb ischemia 38.1% 32.2% arms, respectively. Mean lesion length 23 cm both groups largely TransAtlantic Inter-Society Consensus II D. Hospitalization time 30-day morbidity significantly lower group, without differences serious adverse events (n = 5 each; surgical: 4 venous 1 polytetrafluoroethylene bypass). There no significant Rutherford category between at any point. At 30 days showed greater improvement quality-of-life scores. year, these had disappeared (endoluminal: 64.8%; 63.6%), assisted 78.1%; 79.8%), secondary 85.9%; 83.3%), vessel revascularization 72.1%; 71.0%) observed. Limb salvage rate 100% groups. Conclusions segment shows promising results (less morbidity, faster recovery, life indistinguishable rates year) compared bypass. Long-term be awaited.