Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST).
BACKGROUND
Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year.


RESULTS
Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease.


CONCLUSIONS
In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.
Krankenberg
Hans
H
Hamburg University Cardiovascular Center, Hamburg, Germany. krankenberg@herz-hh.de
Schlüter
Michael
M
Steinkamp
Hermann J
HJ
Bürgelin
Karlheinz
K
Scheinert
Dierk
D
Schulte
Karl-Ludwig
KL
Minar
Erich
E
Peeters
Patrick
P
Bosiers
Marc
M
Tepe
Gunnar
G
Reimers
Bernhard
B
Mahler
Felix
F
Tübler
Thilo
T
Zeller
Thomas
T
D000368:Aged; D000497:Alloys / Q000008:administration & dosage*; D000800:Angioplasty, Balloon / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000473:pathology*; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D015607:Stents; D014463:Ultrasonography
D000497:Alloys; C013616:nitinol