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

JACC Cardiovasc Interv. 2017 Nov 27;10(22):2320-2331. doi: 10.1016/j.jcin.2017.09.013.

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 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.

Keywords: bypass; covered stent; femoropopliteal; patency; quality of life; randomized.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / administration & dosage*
  • Anticoagulants / adverse effects
  • Blood Vessel Prosthesis Implantation / adverse effects
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Blood Vessel Prosthesis*
  • Coated Materials, Biocompatible*
  • Constriction, Pathologic
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Female
  • Femoral Artery / diagnostic imaging
  • Femoral Artery / physiopathology
  • Femoral Artery / surgery*
  • Heparin / administration & dosage*
  • Heparin / adverse effects
  • Humans
  • Intention to Treat Analysis
  • Kaplan-Meier Estimate
  • Length of Stay
  • Male
  • Middle Aged
  • Netherlands
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / surgery*
  • Polytetrafluoroethylene
  • Popliteal Artery / diagnostic imaging
  • Popliteal Artery / physiopathology
  • Popliteal Artery / surgery*
  • Postoperative Complications / etiology
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vascular Patency

Substances

  • Anticoagulants
  • Coated Materials, Biocompatible
  • Polytetrafluoroethylene
  • Heparin