Boston, MA -- Sirolimus-eluting stents (SES’s) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study published by Jeffrey Pompa, M.D., et. al. from Brigham and Women’s Hospital in Boston, Massachusetts in the December 21/28, 2004 edition of Circulation, compared the angiographic outcomes between SESs and balloon-expandable bare-metal stent (BMSs) in patients with complex lesions at high risk of restenosis. The results of this study demonstrate that treatment with the SES in patients with native-vessel coronary artery disease resulted in marked reductions of all angiographic indices of restenosis.  

The purpose of the study was to compare the angiographic outcomes between SESs and BMSs in patients with complex lesions at high risk of restenosis. The restenosis was specifically in regard to (1) the lumen changes within the stent and its 5-mm nonstented edges; (2) the degree and incidence of angiographic renarrowing in patients with smaller vessels and longer lesions; (3) the pattern of angiographic restenosis; and (4) the occurrence of late untoward angiographic findings, including the frequency of aneurysms.  

There were 701 patients with long lesions (15 to 25 mm) in small diameter (2.5 to 3.5 mm) native vessels who were randomly assigned to treatment with SESs or BMSs. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenoses were obtained within the treated segment, within the stent, and within it 5 mm proximal and distal edges. Patients treated with SESs had lower rates of binary ( >50% restenosis) angiographic restenosis than patients treated with BMS ( 8.9% versus 36.3%; P<0.001) within the segment. Within the stent, SES treated patients had 3.2% restenosis versus 35.4% (P<0.001) with the BMS. Patients treated with SESs also had lower restenosis at the distal edges (2.0% versus 7.5% in BMS treated patients; P<0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5 mm proximal and distal edges (all P<0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of aneurysms was similar in the 2 groups.  

The results of this study demonstrate that treatment with the SES in patients with native-vessel coronary artery disease resulted in marked reductions of all angiographic indices of restenosis. When restenosis occurred with the SES treatment, it most often developed at the margins of the stent, whereas a diffuse pattern of restenosis occurred in patients treated with BMS. These beneficial effects were seen in both the smallest vessel and the longest lesion. Thus, from this study, it can be concluded that the use of SES is safe and effective for the treatment of complex native-vessel coronary artery disease.  

Co-authors: Martin B. Leon M.D.; Jeffrey W. Moses, M.D.; David R. Holmes, Jr., M.D.; Nicholas Cox, MBBS; Michelle Fitzpatrick, R.N.; John Douglas, M.D.; Charles Lambert, M.D.; Michael Mooney, M.D.; Steven Yakubov, M.D.; Richard E. Kuntz, M.D., M.Sc.