Sirolimus Stent Safe for Restenosis Patients

A new study reports that sirolimus-eluting stent implantation appears to be safe and effective in restenosis patients originally treated with bare metal stents.

Researchers at San Donato Hospital (Arezzo, Italy) evaluated the success of implanting sirolimus-eluting stents in 244 unselected patients with first-time in-stent restenosis (ISR) in a native coronary artery or saphenous vein graft, who were enrolled in the Tuscany Registry of sirolimus for Unselected in-stent restenosis (TRUE) study.

The sirolimus stents were successfully implanted in all lesions. At nine-month follow-up, four patients (1.6%) had died and four had a myocardial infarction (MI). Ischemia-driven target vessel revascularization (TVR) was seen in 12 patients (4.9%), for a cumulative event-free survival of 227 patients (93%). Although nine-month follow-up angiography was planned in all patients, only 150 (62%) patients completed it, and restenosis was present in 13 (8.7%) of these patients.

Lesion length was an angiographic independent predictor of restenosis, and diabetes and non-ST-segment elevation acute coronary syndrome at presentation were independent predictors of revascularization and major adverse cardiac events. These patients also had a significantly greater incidence of restenosis. The study was reported in the July 18, 2006, issue of the Journal of the American College of Cardiology.

Sirolimus stent implantation for the treatment of in-stent restenosis is effective and safe, concluded lead author Dr. Francesco Liistro and colleagues of the cardiovascular department at San Donato. However, they added, in diabetic patients and in those with acute coronary syndrome, the higher rate of recurrence requires further evaluation.

The sirolimus-eluting stent, marketed under the brand name Cypher by Cordis Corportion (Miami Lakes, FL, USA), is a metal stent coated with 140 microgram/cm2 of sirolimus (rapamycin) blended with synthetic polymers. After stent implantation, sirolimus is slowly released causing localized cytostatic inhibition of proliferation of vascular smooth muscle cells in the peri-stent arterial wall over a period of about one month.



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