Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial.
OBJECTIVE
To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions.


METHODS
This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography.


RESULTS
Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P = .31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P = .20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P = .49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events.


CONCLUSIONS
Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.
Duda
Stephan H
SH
Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital Berlin, Heinz-Galinski-Str. 1, 13347 Berlin, Germany. stephan.duda@t-online.de
Bosiers
Marc
M
Lammer
Johannes
J
Scheinert
Dierk
D
Zeller
Thomas
T
Tielbeek
Alexander
A
Anderson
John
J
Wiesinger
Benjamin
B
Tepe
Gunnar
G
Lansky
Alexandra
A
Mudde
Catharina
C
Tielemans
Hans
H
Bérégi
Jean P
JP
D000368:Aged; D000497:Alloys / Q000737:chemistry; D000792:Angiography; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery; D006083:Graft Occlusion, Vascular / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D007866:Leg / Q000098:blood supply; D008297:Male; D012008:Recurrence; D020123:Sirolimus / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018709:Statistics, Nonparametric; D015607:Stents; D016896:Treatment Outcome
D000497:Alloys; D007166:Immunosuppressive Agents; C013616:nitinol; D020123:Sirolimus