Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study.
OBJECTIVE
To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD).


METHODS
A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42-93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40% of the patients. Mean lesion length was 96.4 mm (range 10-150).


RESULTS
A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4% (141/151) and a second stent in 6.6% (10/151). One-year follow-up information was available for 88.7% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8+/-0.8 (range 1-5) at baseline to 0.6+/-1.1 (range 0-5) at 12 months. The mean ankle-brachial index rose from 0.6+/-0.2 (range 0-1.4) at baseline to 0.9+/-0.2 (range 0-1.2) at 12 months. The rates for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% CI 84.9% to 95.2%) and 72.2% (95% CI 63.8% to 79.6%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1% (95% CI 71.2% to 85.6%). The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%).


CONCLUSIONS
The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.
Bosiers
Marc
M
Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium. marc.bosiers@telenet.be
Torsello
Giovanni
G
Gissler
Hans-Martin
HM
Ruef
Johannes
J
Müller-Hülsbeck
Stefan
S
Jahnke
Thomas
T
Peeters
Patrick
P
Daenens
Kim
K
Lammer
Johannes
J
Schroë
Herman
H
Mathias
Klaus
K
Koppensteiner
Renate
R
Vermassen
Frank
F
Scheinert
Dierk
D
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000800:Angioplasty, Balloon; D050197:Atherosclerosis / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D000497:Alloys; C013616:nitinol