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The Journal of Cardiovascular Surgery 2009 April;50(2):195-203


language: English

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

Hugl B. 1, Nevelsteen A. 2, Daenens K. 2, Alonso Perez M. 3, Heider P. 4, Railo M. 5, Schelzig H. 6, Gluecklich B. 7, Balzer K. 8, Vermassen F. 9, De Smit P. 10, Fraedrich G. 1

1 Department of Vascular Surgery Medical University, Innsbruck, Austria 2 Department of Vascular Surgery University Hospital Gasthuisberg, Leuven, Belgium 3 Department of Vascular Surgery 1 University Hospital Central Asturias, Oviedo, Spain 4 Department of Vascular Surgery Technical University of Munich Rechts der Isar Medical Center, Munich, Germany 5 Department of Vascular Surgery Helsinki University Central Hospital, Helsinki, Finland 6 Department of Thoracic and Vascular Surgery University of Ulm, Ulm, Germany 7 Department of Thoracic and Vascular Surgery Hospital of Rendsburg, Rendsburg, Germany 8 Center of Vascular Surgery, Evangelisches Krankenhaus Mühlheim/Ruhr, Germany 9 Department of Vascular Surgery Gent University Hospital, Gent, Belgium 10 Department of Vascular Surgery


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.
Conclusion. 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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