Heparin-bonded expanded polytetrafluoroethylene femoropopliteal bypass grafts outperform expanded polytetrafluoroethylene grafts without heparin in a long-term comparison.

Expanded polytetrafluoroethylene (ePTFE) grafts have become an acceptable prosthetic alternative to autologous vein for infrainguinal arterial reconstructions. Recently, heparin bonding to the graft's luminal surface has been used as an adjunctive method of improving graft patency. We retrospectively evaluated a prospective experience with heparin-bonded ePTFE (HePTFE) vs the results of a prior experience with standard ePTFE (SePTFE) to compare patency rates in above-knee (AK) and below-knee (BK) femoropopliteal bypass through the 5-year follow-up. Prosthetic femoropopliteal bypasses performed by our four-surgeon group were constructed using 6-mm SePTFE grafts before August 2007. Subsequently, all such bypasses were constructed using 6-mm HePTFE (Propaten graft; W. L. Gore & Associates, Flagstaff, Ariz). The surgical technique used in all cases throughout the study was similar irrespective of surgeon or graft material. Loss of primary patency was defined by graft thrombosis; duplex scan confirmed graft failure. Descriptive estimation of patency rates was carried out using standard Kaplan-Meier methods. Cox proportional hazards regression was used to analyze relationships between predictors and time to loss of patency. There were 192 AK (87 Propaten, 105 SePTFE) and 60 BK (42 Propaten, 18 SePTFE) grafts. Overall primary patency for Propaten was statistically better than SePTFE at years 1 (93.6% vs 84.2%), 2 (79.7% vs 73.8%), 3 (79.7% vs 69.5%), 4 (74.5% vs 59.9%) and 5 (74.5% vs 56.2%; log-rank test, P = .036). Five-year primary patency was superior for Propaten AK grafts (85.2% vs 59.3%; log-rank test, P = .028) and for Propaten BK grafts (59.6% vs 0.0/undeterminable; log-rank test, P = .016). Variables significantly associated with loss of patency for Propaten and SePTFE were claudication (hazard ratio [HR], 0.41), age (HR, 0.95), isolated popliteal artery (HR, 3.1-4.4), and ankle-brachial index after the procedure (HR, 0.10). Controlling for conduit effect, clopidogrel use did not significantly affect patency (P = .076). No grafts were associated with heparin-induced thrombocytopenia. These data show that the Propaten HePTFE graft offered significantly better long-term patency over the SePTFE graft, suggesting Propaten as the prosthetic graft of choice for bypasses to the femoropopliteal artery when autologous vein is unavailable or inappropriate.

Samson RH ，Morales R ，Showalter DP ，Lepore MR Jr ，Nair DG ... -  《-》

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.

Despite improvements in endovascular therapy for lower extremity arterial disease, open surgical revascularization is still required when the disease is extensive. Although autogenous vein is the conduit of choice for open femoropopliteal bypass, prosthetic grafts can be an acceptable alternative when adequate vein is not available. The FUSION BIOLINE heparin-coated vascular graft (Maquet Endovascular, Wayne, NJ) was developed to improve the patency rate associated with standard prosthetic grafts. The current study, the FINEST Trial (Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE), was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective, randomized, controlled, multicenter trial. 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. Among 203 patients in the efficacy analysis, claudication was the presenting symptom in 147 (72.4%), and the site of the distal anastomosis was at the above-knee level in 174 (85.7%). Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at 30 days, 6 months, and 12 months. The primary efficacy end point was primary patency of the study graft. The primary safety end point was the composite of major adverse events and periprocedural death. Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency. 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, a difference of 16.4% (95% confidence interval, 2.7%-29.9%; P = .006), and the respective rates at 12 months were 76.5% and 67.0% (95% confidence interval, -4.8% to 23.0%; P = .05). The mean time to hemostasis of bleeding at the suture hole was 3.5 minutes in the FUSION BIOLINE group and 11.0 minutes in the standard ePTFE group (P < .0001). Major adverse events were significantly lower in the FUSION BIOLINE group, occurring in 17.1%, compared with 30.7% in the standard ePTFE group (P = .033), principally a result of a lower rate of major graft reinterventions through 12 months in the FUSION BIOLINE group (16.2% vs 30.7%). Data from this randomized multicenter study 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. Although the ultimate long-term benefit of the graft cannot be ascertained with the data currently available, the utility of the FUSION BIOLINE vascular graft appears promising.

Lumsden AB ，Morrissey NJ ，Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE (FINEST) Trial Co-investigators 《-》

A comparison of femorocrural bypasses performed with modified heparin-bonded expanded polytetrafluorethylene grafts and those with great saphenous vein grafts to treat critical limb ischemia.

Gessaroli M ，Tarantini S ，Leone M ，Fabbri E ，Panzini I ... -  《-》

Comparison of propaten heparin-bonded vascular graft with distal anastomotic patch versus autogenous saphenous vein graft in tibial artery bypass.

Kaisar J ，Chen A ，Cheung M ，Kfoury E ，Bechara CF ，Lin PH ... -  《-》

Heparin-bonded ePTFE grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results.

Daenens K ，Schepers S ，Fourneau I ，Houthoofd S ，Nevelsteen A ... -  《-》