Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE heparin-coated vascular graft and the standard expanded polytetrafluoroethylene graft for femoropopliteal bypass
Abstract
The FUSION BIOLINE heparin-coated vascular graft was developed to improve the patency rate associated with standard prosthetic grafts. The FINEST Trial was designed to assess the clinical outcome of heparin-coated and standard vascular grafts.
During a 25-month period ending in June 2012, 209 eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene (ePTFE) graft or the heparin-coated FUSION BIOLINE vascular graft. The primary patency rates at 6 months were 86,4% for the FUSION BIOLINE heparin-coated vascular graft group compared with 70,0% for the standard ePTFE group (P= .006).
Data demonstrated improved midterm patency, less bleeding at the suture hole, and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts.