Published Online
on December 13, 2004

A more recent version of this article appeared on December 21, 2004

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Submitted on September 24, 2003
Revised on August 2, 2004
Accepted on August 11, 2004

Quantitative Assessment of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Native Coronary Arteries

Jeffrey J. Popma MD^*, Martin B. Leon MD, Jeffrey W. Moses MD, David R. Holmes Jr MD, Nicholas Cox MBBS, Michelle Fitzpatrick RN, John Douglas MD, Charles Lambert MD, Michael Mooney MD, Steven Yakubov MD, Richard E. Kuntz MD, MSc, for the SIRIUS Investigators

From the Departments of Internal Medicine (Cardiovascular Division) of Brigham and Women’s Hospital, Boston, Mass (J.J.P., N.C., M.F., R.E.K.); Lenox Hill Hospital, New York, NY (M.B.L., J.W.M.); Mayo Clinic, Rochester, Minn (D.R.H.); Emory University Hospital, Atlanta, Ga (J.D.); Health First Institute, Melbourne, Fla (C.L.); Abbott Northwestern Hospital, Minneapolis, Minn (M.M.); Riverside Methodist Hospital, Columbus, Ohio (S.Y.); and the Harvard Clinical Research Institute, Boston, Mass (R.E.K.).

^* To whom correspondence should be addressed. E-mail: jpopma{at}partners.org.

Background--Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis.

Methods and Results--Angiographic follow-up at 240 days was obtained in 701 patients with long (15- to 25-mm) lesions in small-diameter (2.5- to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (>50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; P<0.001) and within the stent (3.2% versus 35.4% with the BMS; 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 late aneurysms was similar in the 2 groups.

Conclusions--Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.

Key words: stents • sirolimus • restenosis • coronary disease

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