Published online before print August 26, 2002, doi: 10.1161/01.CIR.0000029746.10018.36
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(Circulation. 2002;106:1505.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease
Six-Month Results
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.).
Correspondence and reprint requests to Professor Stephan H. Duda, MD, Department of Radiology, University of Tübingen, Eberhard-Karls-University, Hoppe-Seyler-Str 3, 72076 Tübingen, Germany. 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.
Key Words: claudication • peripheral vascular disease • stents • drugs • restenosis
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