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.
J Cardiovasc Surg (Torino)
; 50(2): 195-203, 2009 Apr.
Article
in En
| MEDLINE
| ID: mdl-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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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Polytetrafluoroethylene
/
Arterial Occlusive Diseases
/
Vascular Patency
/
Blood Vessel Prosthesis
/
Heparin
/
Blood Vessel Prosthesis Implantation
/
Coated Materials, Biocompatible
/
Fibrinolytic Agents
/
Graft Occlusion, Vascular
Type of study:
Clinical_trials
/
Etiology_studies
/
Observational_studies
Limits:
Aged
/
Female
/
Humans
/
Male
Country/Region as subject:
Europa
Language:
En
Journal:
J Cardiovasc Surg (Torino)
Year:
2009
Document type:
Article
Affiliation country:
Austria