Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.
BACKGROUND
Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions.


RESULTS
Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85+/-57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P=0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P=0.047). No serious adverse events (death or prolonged hospitalization) were reported.


CONCLUSIONS
The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.
Duda
Stephan H
SH
Department of Diagnostic Radiology, University of Tübingen, Tübingen, Germany. stephan.duda@med.uni-tuebingen.de
Pusich
Benjamin
B
Richter
Goetz
G
Landwehr
Peter
P
Oliva
Vincent L
VL
Tielbeek
Alexander
A
Wiesinger
Benjamin
B
Hak
Jan Bart
JB
Tielemans
Hans
H
Ziemer
Gerhard
G
Cristea
Ecatarina
E
Lansky
Alexandra
A
Bérégi
Jean P
JP
D000368:Aged; D000497:Alloys / Q000737:chemistry; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery / Q000187:drug effects*; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D011859:Radiography; D020123:Sirolimus / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
D000497:Alloys; D007166:Immunosuppressive Agents; C013616:nitinol; D020123:Sirolimus