Results from the FINEST randomised trial show that the Fusion Bioline vascular graft yields higher patency rates in lower limb bypasses in comparison with standard ePTFE grafts at one year. Follow-up data from the study were published in the Journal of Vascular Surgery and also presented at the Charing Cross Symposium (28 April–1 May, London, UK).
US principal investigator Alan B Lumsden, chair, Department of Cardiovascular Surgery, medical director, Methodist DeBakey Heart and Vascular Center, Houston, USA, presented the results on behalf of the FINEST investigators. He explained that FINEST (Comparison of safety and primary patency between Fusion vascular graft with Bioline and Exxcel Soft ePTFE) is a randomised trial designed to assess the performance of the Fusion Bioline vascular graft from Maquet.
Fusion Bioline graft is a combination of a heparin-coated ePTFE graft with a Dacron outer layer glued together with polycarbonate urethane. Lumsden told delegates: “Dacron has stood the test of time. It is extremely durable and thrombogenic, and therefore has been used in high flow vessels like the aorta and the iliacs. ePTFE is less thrombogenic, dominates the lower prosthetic bypasses market, and has been further enhanced with the addition of heparin bonding on the luminal surface. The Fusion Bioline graft blends all these benefits: it is more thrombogenic, producing haemostasis in the suture line, provides the incorporation that has been demonstrated with Dacron, but using the anti-thrombogenic surface heparing-coated ePTFE.”
He commented that the advantages of the bioline coating include the fact that heparin is immobilised on to the graft surface through covalent multipoint attachments, providing exceptional stability to the coating which may prolong the graft’s performance. Heparin is also tightly bound to the albumin surface, allowing heparin to be flexible and extend into the blood flow to be clinically effective. The bioline coating makes the surface more hydrophilic and homogenous, and, in addition, the albumin reduces fibrinogen and platelet adhesions/aggregation. The technology has successfully been used for over 25 years within cardiopulmonary circuits, Lumsden said.
The study enrolled 209 patients (25 sites) between May 2010 and June 2012, of which two thirds were enrolled in Europe and on third in the USA. Of the total of 207 patients treated, 203 were included in the efficacy analysis. In total, 103 patients were randomised to Fusion Bioline and 100 to the standard ePTFE graft.
The FINEST study included patients with claudication, rest pain and superficial ulcers, and the major inclusion criteria were requirement for femoropopliteal above- or below-the-knee bypass, proximal anastomosis on the most distal external iliac artery, common femoral artery or superficial femoral artery, and Rutherford category 1–5. Patients with previous bypass graft in the same limb were excluded from the trial.
Patients presented with standard comorbidities, the majority had the proximal anastomosis in the common femoral artery (94% in the standard ePTFE group and 96.1% in the Fusion Bioline group), and more than 85% had the distal anastomosis above the knee.
Follow-up data from the study showed that Fusion Bioline continued to be superior to the standard ePTFE graft at one year. At six months, the primary patency rate was 86.4% with Fusion Bioline vs. 70% with standard ePTFE (p=0.006); at 12 months, primary patency was 76.5% for Fusion Bioline vs. 67% for standard ePTFE (p=0.050). In terms of adverse events (reinterventions), the trial showed a lower rate (17.1%) with Fusion Bioline vs. 30.7% with the standard ePTFE graft (p=0.033).
Lumsden highlighted that the use of local haemostatic agent was double in the standard ePTFE group (64%) than in the Fusion Bioline group (30.1%, p<0.0001). Time to suture hole haemostasis was shorter in the Fusion Bioline group (3.5 minutes) than in the standard ePTFE group (11 minutes, p<0.001), even though the amount of haemostatic agent was higher in the standard ePTFE group.
He concluded the presentation stating that the FINEST study met its primary endpoint in its FDA IDE analysis that led to the approval of the graft in the USA.
“The Fusion Bioline heparin-coated vascular graft performs extremely well in femoropopliteal bypass procedures. We have seen that primary patency rates are improved with Fusion Bioline compared with those observed with the standard ePTFE graft. Suture hole bleeding is substantially reduced with Fusion Bioline compared to standard ePTFE graft. In summary, Fusion Bioline provides significant clinical benefits over standard ePTFE femoropopliteal grafts,” Lumsden said.
Afshin Assadian, Vascular and Endovascular Surgery, Wilhelminenspital Vienna, Austria, an investigator in the FINEST trial, comments: “The benefit of Fusion Bioline over standard ePTFE in a randomised population is clear and an important piece of evidence. The benefit may be due to heparin, the physical properties of the graft, or a combination of both. The bottom line is that the Fusion Bioline graft performs significantly better than standard ePTFE graft.”
Assadian notes that Fusion Bioline has the benefits of improving haemostasis and promoting tissue in-growth, and has axial compliance for better handling compared with standard ePTFE grafts. He adds that the results of the FINEST trial reflect what he has experienced in his clinical practice. “Because of the performance of the Fusion Bioline graft, we no longer use standard ePTFE grafts,” he says.