PTFE-covered self-expanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective study.
OBJECTIVE
To evaluate the technical performance, safety, and 1-year clinical efficacy of polytetrafluoroethylene (PTFE)-covered nitinol stents in the treatment of atherosclerotic iliac and superficial femoral artery (SFA) disease.


METHODS
The multicenter, prospective, nonrandomized COVENT study involved 98 patients (70 men; mean age 64+/-10 years) who received PTFE-covered nitinol stents in 107 arteries (60 iliac and 47 SFAs) after predilation. The average lesion length was 50 mm in the SFA and 45 mm in the iliac arteries. Postdilation was performed when necessary. Duplex ultrasound and ankle-brachial index (ABI) were performed at discharge and at 1, 6, and 12 months in follow-up.


RESULTS
In total, 130 stents were placed successfully in 97 (99%) of 98 patients. One stent was misplaced during deployment and required subsequent surgical removal. The average stenosis grade was reduced from 98% to 6% in the SFAs and from 96% to 4% in the iliac arteries after covered stent placement. There was a significant rise of the mean ABI from 0.64 at baseline to 0.97 and 0.95 at 1 and 12 months, respectively (p<0.001). There were 7 primary covered stent occlusions (6.5% of 107 stented lesions: 3 not treated, 2 bypassed, 2 dilated or stented) and 5 (4.7%) recurrent in-stent occlusions (1 bypassed, 2 dilated, 2 untreated) during the 1-year follow-up. Primary patency rates were 92% at 6 months and 89.8% at 12 months for the entire cohort. Secondary patency rates were 98% and 95.6%, respectively. No statistically significant differences were observed in the primary patency rates for the SFAs (89.3% at both 6 and 12 months) versus the iliac arteries (94.3% at 6 months and 90.7% at 12 months).


CONCLUSIONS
Primary implantation of PTFE-covered nitinol stents in the iliac and superficial femoral arteries is technically feasible, safe, and effective, with excellent 1-year patency.
Wiesinger
Benjamin
B
Division of Diagnostic Radiology, Department of Radiology, University of Tübingen, Germany. benjamin.wiesinger@med.uni-tuebingen.de
Beregi
Jean-Paul
JP
Oliva
Vincent L
VL
Dietrich
Tobias
T
Tepe
Gunnar
G
Bosiers
Marc
M
Hüttl
Kayman
K
Müller-Hülsbeck
Stefan
S
Bray
Alan
A
Tielemans
Hans
H
Duda
Stephan H
SH
D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D007083:Iliac Artery; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
D000497:Alloys; C013616:nitinol; D011138:Polytetrafluoroethylene