on August 26, 2002
Published online before print August 26, 2002, doi: 10.1161/01.CIR.0000029746.10018.36
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Submitted on March 29, 2002
From the Department of Diagnostic Radiology (S.H.D., B.P., B.W.) and the Division of Thoracic, Cardiac, and Vascular Surgery (G.Z.), the University of Tübingen, Tübingen, Germany; the Department of Diagnostic Radiology (G.R.), University of Heidelberg, Heidelberg, Germany; the Department of Radiology, Henriettenstiftung (P.L.), Hannover, Germany; the Department of Diagnostic Radiology (J.P.B.), University of Lille, Lille, France; the Department of Radiology (V.L.O.), University of Montréal, Montréal, Canada; the Department of Radiology, Catharina Hospital of Eindhoven (A.T.), the Netherlands; the Cardiovascular Research Foundation (E.C., A.L.), New York, NY; and Cordis, a Johnson & Johnson Company, Warren, NJ, and Waterloo, Belgium (J.B.H., H.T.). * To whom correspondence should be addressed. E-mail: stephan.duda{at}med.uni-tuebingen.de.
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. Methods and 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.
Revised on June 27, 2002
Accepted on June 27, 2002
Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease. Six-Month Results
Stephan H. Duda MD*,
Key words: claudication • peripheral vascular disease • stents • drugs • restenosis
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