Cost-Effectiveness of Sirolimus-Eluting Stents in Complex Coronary Lesions

1. Cost-Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex Coronary Stenoses: The SIRIUS Trial David J. Cohen, MD, MSc Ameet Bakhai, MD, Chunxue Shi, MS, Louise Githiora, Ronna H. Berezin, MPH, Ronald P. Caputo, M.D., Charles O’Shaugnessy, M.D., Martin B. Leon, MD, Jeff Moses, MD,, Richard E. Kuntz, MD, MSc, on behalf of the SIRIUS Investigators Harvard Clinical Research InstituteBoston, MA

2. Conflicts of Interest Study funding • Cordis, Inc. Other Research Grants • Millenium Pharmaceuticals • The Medicines Company • Eli Lilly • Guidant • Boston Scientific • Medtronic

3. Background • Recent studies have demonstrated that sirolimus-eluting stents dramatically reduce both angiographic and clinical restenosis compared with conventional stenting • The incremental cost of this technology is substantial, however, and may pose a barrier to widespread adoption at both the hospital and health system level • Nonetheless, sirolimus-eluting stents may be reasonably cost-effective if follow-up costs are substantially reduced due to avoidance of rehospitalization and repeat revascularization procedures

4. Objectives • To compare the in-hospital and long-term costs of PCI using the sirolimus-eluting stent with those of PCI using conventional, bare metal stents • To examine the overall cost-effectiveness of the sirolimus-eluting stent compared with conventional stenting in patients undergoing PCI of “real world” coronary lesions • To examine the impact of clinical restenosis on long-term costs of care for patients undergoing PCI in contemporary practice

5. SIRIUS Patient Population Inclusion Criteria • De novo coronary lesion documented myocardial ischemia • Lesion length 15-30 mm (visual estimate) • Reference vessel diameter 2.5 – 3.5 mm (visual estimate)

6. SIRIUS Patient Population Exclusion Criteria • Planned multivessel or staged PCI • Major sidebranch involvement • Total occlusion • Ostial location • Recent MI • Chronic renal insufficiency • Allergy to ASA or thienopyridine

7. Randomized Patients (n=1101) Deregistered (n=23) Deregistered (n=20) Sirolimus-Eluting BX Velocity Stent (n=533) Control BX Velocity Stent (n=525) 9 month primary endpoint: Target Vessel Failure 12-month clinical f/u Cost-effectiveness

8. SIRIUS - Study Administration Principal investigators: M.B. Leon and J.W. Moses, Lenox Hill Hospital & CRF, New York NY Study coordination: R.E. Kuntz, Harvard Clinical Research Institute and Brigham and Women’s Hospital, Boston MA Angiographic core lab: J.J. Popma, Brigham and Women’s Hospital, Boston MA IVUS core lab: P. Fitzgerald, Stanford Medical Center, Palo Alto, CA Economic core lab: R. Berezin, T. Lavelle, L. Githiora, C. Shi, A. Bakhai, HCRI and BIDMC, Boston MA Sponsor: Cordis, A Johnson & Johnson Company, Warren, N.J.

9. SIRIUS Baseline Characteristics: Clinical P= NS for all comparisons

10. SIRIUS Angiographic Characteristics P= NS for all comparisons

11. SIRIUS Procedural Resource Utilization and Cost

12. SIRIUS Initial Hospital Costs D = $2880 (p<0.001) $11,345 ± 3211 * $8464 ± 2497 * P<0.001 vs. Control *

13. SIRIUS 12-Month Events: Repeat Revascularization 54%P<0.001 70%P<0.001 76%P<0.001

14. SIRIUS 12-Month Events: Type of Revascularization 54%P<0.001 57%P=0.05

15. SIRIUS 1-Year Medical Care Costs D = +$309 (p=0.64) $16,813 + 9737 $16,504 + 11,511

16. SIRIUS: Cost-Effectiveness Results

17. Summary/Conclusions • These results suggest that use of the sirolimus-eluting stent is highly cost-effective for the target population of the SIRIUS trial • Availability of longer stents and improved implantation techniques should further enhance the cost-effectiveness of this technology in the immediate future. • Further studies are necessary to extend these findings to other populations including diffuse disease, SVG disease, and multivessel PCI