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

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

SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial

Contains fulltext : 96315.pdf (publisher's version ) (Open Access)BACKGROUND: Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not. METHODS/DESIGN: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications. DISCUSSION: The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications. TRIAL REGISTRATION: Clinicaltrials: NCT01220245

One-year results of heparin-bonded ePTFE-covered stents for chronic occlusive superficial femoral artery disease

ObjectiveThe purpose of this study was to assess the 1-year patency rates of heparin-bonded covered stents in the treatment of chronic occlusive disease of the superficial femoral artery (SFA).MethodsAll patients treated with a heparin-bonded endograft between April 2009 and October 2010 for chronic occlusive disease of the SFA were prospectively gathered in a database and retrospectively analyzed. Primary, primary-assisted, and secondary patency rates, assessed by ultrasound scanning, were analyzed at 1-year, as were the complication rates and mortality.ResultsA total of 56 limbs were treated with a heparin-bonded covered stent in 53 patients for chronic ischemia Rutherford category 3 (n = 36), 4 (n = 5), 5 (n = 11), and 6 (n = 1). Lesions were classified as TransAtlantic Inter-Society Consensus (TASC)-2-B (n = 9), C (n = 14), and D (n = 33), and the mean treated lesion length was 18.5 ± 7.7 cm. Postoperative complications occurred in 7.5%, including hematoma (n = 1), edema (n = 1), pneumonia (n = 1), and urinary retention (n = 1), and the 30-day mortality rate was 0%. The mean follow-up was 413 ± 208 days. At 1 year, the primary patency was 76%, the primary-assisted patency 82%, and the secondary patency 89%. The limb salvage rate was 100%.ConclusionsHeparin-bonded covered stents seem to provide a valid alternative to surgical treatment of long occlusive lesions in the SFA. Randomized trials and long-term data are required before considering the technique as a new standard of care