RESUMEN
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.
Asunto(s)
Arteriopatías Oclusivas/tratamiento farmacológico , Arteria Femoral/efectos de los fármacos , Inmunosupresores/uso terapéutico , Sirolimus/uso terapéutico , Stents , Anciano , Aleaciones/química , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/metabolismo , Método Doble Ciego , Femenino , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/prevención & control , Humanos , Inmunosupresores/efectos adversos , Inmunosupresores/farmacocinética , Masculino , Radiografía , Sirolimus/efectos adversos , Sirolimus/farmacocinética , Stents/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: The DIA Clinical Data Management Community created a committee to develop a model standard operating procedure (SOP) for writing a data management plan. METHODS: The goal of the committee was to develop a plan that could be used by industry and academic institutions. The model was based on contributed examples from committee members and their experiences with current practices and technologies. It is understood that as new clinical trial technology is implemented, the SOP will require modification. RESULTS: The model SOP and associated templates are presented as a starting point, and each company or institution will need to modify them to meet its individual needs. CONCLUSION: The model DMP SOP produced addresses most data management issues that are present in any phase clinical trial while providing a flexible framework.
RESUMEN
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.