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
Highlights
Endovascular treatment options for the superficial femoral artery are evolving rapidly
The SUrgical versus PERcutaneous Bypass (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 superficial femoral artery (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
Study objectives The aim of the study is to demonstrate that the heparinbonded endograft provides equal patency rates compared to the venous surgical femoro-popliteal bypass
Summary
Endovascular treatment options for the superficial femoral artery are evolving rapidly. May provide equal patency rates compared to the prosthetic above knee bypass. 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. In the treatment of long lesions of the superficial femoral artery (SFA) the surgical venous bypass is considered the gold standard [1]. The efficacy of an ePTFE-covered nitinol stent (Viabahn, W.L. Gore, Flagstaff, AZ, USA) in treating chronic SFA long lesions, of over 8 cm length, is currently being compared to bare nitinol stents in a multicentre randomized controlled trial (VIBRANT trial). The 4-year’s results of a randomized trial have been published comparing an ePTFE-covered nitinol stent with the above-knee ePTFE femoropopliteal bypass [9]. The risk of wound complications, limb edema, loss of the great saphenous vein, and cardiac complications may have to be taken into account when deciding to treat surgically or endovascularly
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