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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Two-Year Outcomes After Sirolimus-Eluting Stent Implantation

Results From the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) Trial

Giora Weisz, MD^_*, Martin B. Leon, MD^_*,_*,1, David R. Holmes, Jr, MD, Dean J. Kereiakes, MD, Mel R. Clark, MD, Barry M. Cohen, MD^¶,2, Stephen G. Ellis, MD^||,3, Patrick Coleman, MD^#, Carolyn Hill^_**, Chunxue Shi, MS, Donald E. Cutlip, MD, Richard E. Kuntz, MD, MSc and Jeffrey W. Moses, MD^_*,4

^_* Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York
Saint Mary’s Hospital, Rochester, Minnesota
Ohio Heart Health Center, Cincinnati, Ohio
Intergris Oklahoma Heart Center, Oklahoma City, Oklahoma
^¶ Morristown Memorial Hospital, Morristown, New Jersey
^|| Cleveland Clinic Foundation, Cleveland, Ohio
^# Northern California Research Association, Santa Rosa, California
^_** Cordis (Johnson & Johnson), Warren, New Jersey
Harvard Clinical Research Institute, Boston, Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts
Brigham and Women’s Hospital, Boston, Massachusetts

Manuscript received January 9, 2005; revised manuscript received October 28, 2005, accepted November 7, 2005.

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

OBJECTIVES: The purpose of this study was to examine the two-year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study.

BACKGROUND: The SIRIUS study was a double-blinded randomized study which 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 with de novo native coronary artery lesions randomized to either SES (533 patients) or control BMS (525 patients) were followed for two years.

RESULTS: Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively (p < 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1% versus 24.4% and 12.0% versus 26.7%, respectively (p < 0.0001 for both). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups.

CONCLUSIONS: Clinical outcomes two years after implantation of SES continue to demonstrate significant reduction in the need for repeat target lesion (and vessel) revascularization compared with BMS without evidence for either disproportionate late restenosis or late stent thrombosis.

Abbreviations and Acronyms   BMS = bare-metal stents   LAD = left anterior descending coronary artery   MACE = major adverse cardiac event   PES = paclitaxel-eluting stents   SES = sirolimus-eluting stents   SIRIUS = Sirolimus-Eluting Stent in De Novo Native Coronary Lesions   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization

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