Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial.
OBJECTIVE
To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency.


METHODS
In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio< 2.5.


RESULTS
At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6±0.2 to 0.9±0.19; P<.0001). Primary and secondary patency rates were 73% and 92%. The primary patency for devices oversized<20% at the proximal landing zone was 88%, whereas the primary patency for devices oversized by>20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs>20 cm). The 30-day major adverse event rate was 0.8%.


CONCLUSIONS
The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes.
North County Radiology Medical Group, 3156 Vista Way, Suite 100, Oceanside, CA 92056, USA. rsaxon5@gmail.com
Richard R
RR
Saxon
Arun
A
Chervu
Paul A
PA
Jones
Tanvir K
TK
Bajwa
Dennis R
DR
Gable
Peter A
PA
Soukas
Richard J
RJ
Begg
John G
JG
Adams
Gary M
GM
Ansel
Darren B
DB
Schneider
Charles M
CM
Eichler
Michael J
MJ
Rush
D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D020099:Coated Materials, Biocompatible / Q000138:chemical synthesis; D054855:Drug-Eluting Stents; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005263:Femoral Artery / Q000187:drug effects / Q000601:surgery; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000628:therapy*; D011138:Polytetrafluoroethylene / Q000737:chemistry*; D011150:Popliteal Artery / Q000187:drug effects / Q000601:surgery; D016896:Treatment Outcome; D014481:United States
D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D011138:Polytetrafluoroethylene; D006493:Heparin