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Circulation. 2004;109:634-640
doi: 10.1161/01.CIR.0000112572.57794.22
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Right arrow Catheter-based coronary interventions: stents

(Circulation. 2004;109:634-640.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Analysis of 1-Year Clinical Outcomes in the SIRIUS Trial

A Randomized Trial of a Sirolimus-Eluting Stent Versus a Standard Stent in Patients at High Risk for Coronary Restenosis

David R. Holmes, Jr, MD; Martin B. Leon, MD; Jeffrey W. Moses, MD; Jeffrey J. Popma, MD; Donald Cutlip, MD; Peter J. Fitzgerald, MD, PhD; Charles Brown, MD; Tim Fischell, MD; Shing Chiu Wong, MD; Mark Midei, MD; David Snead, PhD; Richard E. Kuntz, MD, MSc

From Saint Mary’s Hospital (D.R.H.), Rochester, Minn; Lenox Hill Hospital, New York, NY (M.B.L., J.W.M.); Brigham and Women’s Hospital (J.J.P., R.E.K., D.C.), Boston, Mass; Stanford University Medical Center (P.J.F.), Stanford, Calif; Piedmont Hospital (C.B.), Atlanta, Ga; Borgess Medical Center (T.F.), Kalamazoo, Mich; Cornell University New York Presbyterian Hospital (S.C.W.), New York, NY; Saint Joseph’s Hospital (M.M.), Baltimore, Md; and Cordis (D.S.), Warren, NJ.

Reprint requests to David R. Holmes, Jr, MD, Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905. E-mail dholmes{at}mayo.edu

Received August 14, 2003; revision received October 31, 2003; accepted October 31, 2003.

Background— This study evaluated a large group of patients enrolled in a double-blind randomized trial of the sirolimus-eluting stent to document whether the initial clinical improvement seen in previous smaller series is maintained out to 12 months and to study the potential treatment effect in patient subsets known to be at increased risk of restenosis.

Methods and Results— A total of 1058 patients with de novo native coronary stenosis undergoing clinically indicated percutaneous coronary intervention were randomly assigned to sirolimus-eluting stent (533) or control bare stent (525). Procedural success and in-hospital outcomes were excellent and did not differ between the 2 groups. At 9 months, clinical restenosis, defined as target-lesion revascularization, was 4.1% in the sirolimus limb versus 16.6% in the control limb (P<0.001). At 12 months, the absolute difference in target-lesion revascularization continued to increase and was 4.9% versus 20% (P<0.001). There were no differences in death or myocardial infarction rates. In high-risk patient subsets, defined by vessel size, lesion length, and presence of diabetes mellitus, there was a 70% to 80% reduction in clinical restenosis at 1 year.

Conclusions— Placement of the sirolimus-eluting stent results in continued clinical improvement at 1 year after initial implantation, with significant reduction in clinical restenosis as defined by target-lesion revascularization. Between 9 and 12 months, the absolute reduction of clinical restenosis continues to increase. Even in high-risk subsets of patients, there is a 70% to 80% relative reduction in clinical restenosis at 12 months with this drug-eluting stent.


Key Words: stents • sirolimus • restenosis • coronary disease




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