Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions.
BACKGROUND
Recent randomized trials investigating stent implantation compared with balloon angioplasty for treatment of superficial femoral artery (SFA) disease have given divergent results in short (mean 5 cm) and intermediate (mean 10 cm) lesions. We reinvestigated whether primary nitinol stenting is associated with a morphologic and clinical benefit when compared with percutaneous transluminal angioplasty with optional stenting (PTA) in intermediate-length lesions.


METHODS
We randomly assigned 73 patients with severe claudication or chronic limb ischemia and average 8 cm long (range 3-20 cm) SFA stenosis or occlusion to primary stent implantation (n = 34) or PTA (n = 39). Restenosis >50% and clinical outcome were assessed at 3, 6, and 12 months postintervention.


RESULTS
Average length of the treated segments was 98 + or - 54 mm and 71 + or - 43 mm in the stent and PTA groups (P = 0.011), respectively. In the PTA group, secondary stenting was performed in 10 of 39 patients (26%) due to a suboptimal result after balloon dilation. Restenosis rates in the stent and PTA groups were 21.9% versus 55.6% (P = 0.005) at 6 months by CT-angiography, and 2.9% versus 18.9% (P = 0.033), 18.2% versus 50.0% (P = 0.006), and 34.4% versus 61.1% (P = 0.028) at 3, 6, and 12 months by sonography, respectively. Clinically, patients in the stent group reported a significantly higher maximum walking capacity compared with the PTA group at 6 and 12 months.


CONCLUSIONS
In this randomized multicenter trial, primary stenting with a self-expanding nitinol stent for treatment of intermediate length SFA disease resulted morphologically and clinically superior midterm results compared with balloon angioplasty with optional secondary stenting.
Dick
Petra
P
Department of Angiology, Medical University Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria, Europe. petra.dick@meduniwien.ac.tat
Wallner
Hubert
H
Sabeti
Schila
S
Loewe
Christian
C
Mlekusch
Wolfgang
W
Lammer
Johannes
J
Koppensteiner
Renate
R
Minar
Erich
E
Schillinger
Martin
M
D000368:Aged; D000497:Alloys; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D001317:Austria; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D012008:Recurrence; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014654:Vascular Patency; D016138:Walking
D000497:Alloys; C013616:nitinol