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  • Title: PEPE II--a multicenter study with an end-point heparin-bonded expanded polytetrafluoroethylene vascular graft for above and below knee bypass surgery: determinants of patency.
    Author: Hugl B, Nevelsteen A, Daenens K, Perez MA, Heider P, Railo M, Schelzig H, Gluecklich B, Balzer K, Vermassen F, De Smit P, Fraedrich G, PEPE II Study Group.
    Journal: J Cardiovasc Surg (Torino); 2009 Apr; 50(2):195-203. PubMed ID: 19329916.
    Abstract:
    AIM: The Propaten European Product Evaluation (PEPE II) study was a product evaluation intended to characterize the performance of the GORE PROPATEN vascular graft in above-knee (AK) and below-knee bypass (BK) surgery. METHODS: This prospective multicenter trial enrolled 142 patients with peripheral arterial disease. In 87 patients AK and in 52 patients BK bypasses (including 15 femorocrural) were implanted (67.6% males, 32.4% females). RESULTS: The one-year overall primary and secondary patency rates were 80% and 84.7%, respectively. Overall limb salvage rate at 12-months was 96.2%. The primary patency rate for AK bypasses was 82.7%, for BK femoro-popliteal bypasses 74.2% and for BK tibial-peroneal bypasses 79.4%. Secondary patency rates were 87.3%, 78.8% and 85.1%, respectively. Primary patency rates decreased depending on the number of patent run-off vessels (three 84.3%, two 80.8%, one 73.3%). Subgroup analysis showed that female patients had a significantly higher primary patency rate for BK bypasses (95.5% vs. 67.8%, P=0.037 ) compared to male patients. Subgroup analysis comparing patients younger and older than 70 years did not show a statistically significant difference in patency rates. Twenty-one patients underwent 42 reinterventions after bypass surgery. CONCLUSIONS: Present data show that the end-point heparin-bonded polytetrafluoroethylene graft yields patency rates comparable to those obtained with other graft material in above-knee locations. The encouraging results for BK bypasses suggests that this graft is an excellent option for small diameter vascular reconstructions when autologous vein is unavailable.
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