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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Five-Year Follow-Up After Sirolimus-Eluting Stent Implantation

Results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial

Giora Weisz, MD^_*,_*, Martin B. Leon, MD^_*, David R. Holmes, Jr, MD, Dean J. Kereiakes, MD, Jeffrey J. Popma, MD, Paul S. Teirstein, MD^||, Sidney A. Cohen, MD, PhD^¶,#, Hong Wang, MD, MPH^#, Donald E. Cutlip, MD^_** and Jeffrey W. Moses, MD^_*

^_* Center for Interventional Vascular Therapy, New York-Presbyterian Hospital, Columbia University, and Cardiovascular Research Foundation, New York, New York
Saint Mary's Hospital, Rochester, Minnesota
Ohio Heart Health Center, Cincinnati, Ohio
St. Elizabeth's Medical Center, Boston, Massachusetts
^|| Scripps Clinic and Research Institute, La Jolla, California
^¶ University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
^# Cordis (Johnson & Johnson), Warren, New Jersey
^_** Beth Israel Deaconess Medical Center and Harvard Clinical Research Institute, Boston, Massachusetts

Manuscript received January 6, 2008; revised manuscript received January 7, 2009, accepted January 12, 2009.

^_* Reprint requests and correspondence: Dr. Giora Weisz, Center for Interventional Vascular Therapy (CIVT), Columbia University Medical Center, Herbert Irving Pavilion, 161 Fort Washington Avenue, 5th Floor, New York, New York 10032 (Email: gweisz{at}crf.org).

Objectives: The aim of this study was to examine the 5-year clinical safety and efficacy outcomes in patients enrolled in the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) trial.

Background: The SIRIUS trial was a double-blinded randomized study that demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS).

Methods: Patients (n = 1,058) with de novo native coronary artery lesions were randomized to either SES (n = 533) or control BMS (n = 525) and were followed for 5 years.

Results: Between 1 and 5 years, additional clinical events were similarly distributed among the sirolimus and control groups. At 5 years, in sirolimus versus control patients, target lesion revascularization was 9.4% versus 24.2% (p < 0.001) and major adverse cardiovascular events and target vessel failure rates were 20.3% versus 33.5% and 22.5% versus 33.5%, respectively (p < 0.0001 for both). There were no significant differences in death, myocardial infarction, and nontarget lesion revascularization. No significant differences were observed in the cumulative incidence of stent thrombosis for sirolimus versus control patients with either protocol-derived (1.0% vs. 0.8%) or Academic Research Consortium definitions (3.9% vs. 4.2%).

Conclusions: In patients with noncomplex coronary artery disease, clinical outcomes 5 years after implantation of SES continue to demonstrate significant reduction in the need for repeat revascularization, with similar safety (death and myocardial infarction) compared with BMS, without evidence for either disproportionate late restenosis or late stent thrombosis.

Key Words: coronary disease • diabetes mellitus • restenosis • stents • thrombosis

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   MACE = major adverse cardiac event(s)   MI = myocardial infarction   OR = odds ratio   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization

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