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Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.
Duda, Stephan H; Pusich, Benjamin; Richter, Goetz; Landwehr, Peter; Oliva, Vincent L; Tielbeek, Alexander; Wiesinger, Benjamin; Hak, Jan Bart; Tielemans, Hans; Ziemer, Gerhard; Cristea, Ecatarina; Lansky, Alexandra; Bérégi, Jean P.
Afiliación
  • Duda SH; Department of Diagnostic Radiology, University of Tübingen, Eberhard-Karls-University, Hoppe-Seyler-Str 3, 72076 Tübingen, Germany. stephan.duda@med.uni-tuebingen.de
J Invasive Cardiol ; 16 Suppl A: 15A-19A, 2004 Jan.
Article en En | MEDLINE | ID: mdl-23573600
ABSTRACT

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 instent 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.
Asunto(s)
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Banco de datos: MEDLINE Asunto principal: Arteriopatías Oclusivas / Stents / Stents Liberadores de Fármacos / Arteria Femoral Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Aged / Female / Humans / Male Idioma: En Revista: J Invasive Cardiol Asunto de la revista: CARDIOLOGIA Año: 2004 Tipo del documento: Article País de afiliación: Alemania
Buscar en Google
Banco de datos: MEDLINE Asunto principal: Arteriopatías Oclusivas / Stents / Stents Liberadores de Fármacos / Arteria Femoral Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Aged / Female / Humans / Male Idioma: En Revista: J Invasive Cardiol Asunto de la revista: CARDIOLOGIA Año: 2004 Tipo del documento: Article País de afiliación: Alemania