No 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, 85Ϯ57 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 (Pϭ0.294). 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; Pϭ0.047). 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.

Palmaz balloon-expandable stents were placed in 28 hypertensive patients with atherosclerosis involving the ostia of the renal arteries. Stents were placed to treat elastic recoil immediately after conventional angioplasty in 20 patients and restenosis after percutaneous transluminal angioplasty in eight patients. Technical success (greater than 30% residual stenosis) was achieved in 27 patients. Complications occurred in five patients. At follow-up (1-25 months), hypertension was cured in three patients and improved in 15 patients, with a cumulative cure or improvement of 64% at 6 months. Of 14 patients with a serum creatinine level of 1.5 mg/dL (132.6 mumol/L) or greater before the placement of stents, five demonstrated improved renal function, five showed stabilization of their condition, and four demonstrated deterioration. Follow-up angiography (2-18 months) was performed in 18 patients. Restenosis was present in seven patients and was accompanied by a relapse of hypertension in only three patients. Of the other four patients with restenosis, two had no initial improvement and two had an initial response without a relapse of hypertension. In this preliminary study, renal stents were beneficial in many patients with poor results from conventional angioplasty for ostial atheroma.