Author + information
- Received January 6, 2008
- Revision received January 7, 2009
- Accepted January 12, 2009
- Published online April 28, 2009.
- 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*
- ↵*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
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.
Dr. Leon has served on the advisory board and received consulting fees from Cordis, Johnson & Johnson. Dr. Kereiakes has served on the scientific advisory boards of Boston Scientific Corp., Reva Medical, and Abbott Vascular, and served as consultant for Cordis, Reva Medical, Medtronic, Eli Lilly, and Daichi-Sanyo. Dr. Popma has received a research grant for study and served on the advisory board for Cordis, Johnson & Johnson. Dr. Teirstein has received research grants and consulting fees from Cordis, Johnson & Johnson, and served as consultant to and received honorarium from Boston Scientific, Medtronic, and Abbott. Drs. Cohen and Wang are employees of Cordis, Johnson & Johnson. Dr. Moses has received consulting fees from Cordis, Johnson & Johnson.
- Received January 6, 2008.
- Revision received January 7, 2009.
- Accepted January 12, 2009.
- American College of Cardiology Foundation