Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.
Circulation
; 106(12): 1505-9, 2002 Sep 17.
Article
em En
| MEDLINE
| ID: mdl-12234956
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 ANDRESULTS:
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Arteriopatias Oclusivas
/
Stents
/
Sirolimo
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Artéria Femoral
/
Imunossupressores
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
Limite:
Aged
/
Female
/
Humans
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Male
Idioma:
En
Ano de publicação:
2002
Tipo de documento:
Article