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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 et al. 20091

Department of Vascular Surgery, Medical University, Innsbruck, Austria

Primary patency of GORE® PROPATEN® Vascular Graft

N=37
1 year 74%

 

 

N=15
1 year 79%

 

 


Patient characteristics*

Characteristic N %
Fontaine classification stage  
Stage I 1 < 1%
Stage II 62 45%
Stage III 26 19%
Stage IV 50 36%
Vessel runoff  
1 40 29%
2 50 36%
3 47 34%
Hypertension 98 71%
Diabetes 59 42%
Current tobacco use 58 42%

Study details

  • Prospective, non-randomized, multi-center study
  • Patients without suitable autologous vein
  • The 1-year secondary patency rates for below-knee fem-pop and infrapopliteal bypasses were 79% and 85%, respectively
  • Overall 1-year patency and limb salvage rates were 80% and 96%, respectively*

…present data show that using the endpoint heparin bonded ePTFE graft for lower limb revascularization produces excellent results for AK bypasses and encouraging results for BK bypasses, when compared with data obtained from studies which used other prosthetic material. These encouraging results for BK bypasses were even seen in the subgroup of patients that generally have worse revascularization results due to the presence of risk factors. — B. Hugl

…our data suggests that the use of this graft is an excellent option when no autologous vein is available. — B. Hugl


* Total  N = 139, which includes 87 patients with above knee bypasses

1. Hugl B, Nevelsteen A, Daenens K, et al. PEPE II Study Group.  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.  Journal of Cardiovascular Surgery 2009;50(2):195-203.