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

Abstract

BackgroundEndovascular 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/designTwo-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.DiscussionThe 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 RegistrationClinicaltrials: NCT01220245

Three-year outcome of the heparin-bonded Viabahn for superficial femoral artery occlusive disease

“…Nevertheless, studies like the SuperB trial, comparing the heparinbonded Viabahn with the venous bypass, are essential to provide further support for an endovascular-first strategy also in extensive SFA occlusive disease. 8 The minimally invasive character of the endovascular treatment may be reflected in the low morbidity rate. Surgical bypass of the femoropopliteal region is known for a relatively high morbidity, including wound healing problems, graft infection, and edema.…”

“…The initiation time of the randomized SUrgical vs PERcutaneous Bypass (SuperB) trial, comparing the heparinbonded Viabahn with the venous femoropopliteal bypass, was the end date of inclusion in the present study. 8 Patients of this cohort may also have been included in other subanalyses. 3,[9][10][11][12] Data were retrospectively collected and anonymously analyzed.…”

Efficacy of treatment of edge stenosis of endografts inserted for superficial femoral artery stenotic disease

“…Short‐term patency of heparin‐bonded endografts have been related to patency rates in the SFA that approach the surgical results, although comparative data are still lacking . The ongoing SuperB Trial will hopefully give a definitive answer if these endografts are a valid alternative for the venous surgical femoropopliteal bypass .…”

Results of heparin-bonded ePTFE-covered stents for chronic occlusive superficial femoral artery disease

“…Comparative studies with either bare metal stents and surgical bypass, assessing both patency rates and quality of life, such as the SUrgical versus PERcutaneous Bypass (SUPERB) and the Viabahn vs Bare Nitinol Stent (VIBRANT) in the treatment of long lesion (Ն8 cm) superficial femoral artery occlusive disease trials, are essential in defining the role of heparin-covered endografts in the treatment algorithm of chronic occlusive SFA disease. 21 In the last decade, multiple case series and few randomized trials have been published focusing on nonheparinbonded endografts for SFA occlusive disease. Treatment strategies greatly varied, making comparisons inappropriate.…”