Cost-Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex Coronary Stenoses:
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Cost-Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex Coronary Stenoses: The SIRIUS Trial.

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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


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Conflicts of Interest of Complex Coronary Stenoses:

Study funding

  • Cordis, Inc.

    Other Research Grants

  • Millenium Pharmaceuticals

  • The Medicines Company

  • Eli Lilly

  • Guidant

  • Boston Scientific

  • Medtronic


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Background of Complex Coronary Stenoses:

  • 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


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Objectives of Complex Coronary Stenoses:

  • 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


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SIRIUS of Complex Coronary Stenoses:

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)


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SIRIUS of Complex Coronary Stenoses:

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


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Randomized Patients (n=1101) of Complex Coronary Stenoses:

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


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SIRIUS of Complex Coronary Stenoses: - 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.


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SIRIUS of Complex Coronary Stenoses:

Baseline Characteristics: Clinical

P= NS for all comparisons


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SIRIUS of Complex Coronary Stenoses:

Angiographic Characteristics

P= NS for all comparisons


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SIRIUS of Complex Coronary Stenoses:

Procedural Resource Utilization and Cost


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SIRIUS of Complex Coronary Stenoses:

Initial Hospital Costs

D = $2880 (p<0.001)

$11,345 ± 3211 *

$8464 ± 2497

* P<0.001 vs. Control

*


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SIRIUS of Complex Coronary Stenoses:

12-Month Events: Repeat Revascularization

54%P<0.001

70%P<0.001

76%P<0.001


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SIRIUS of Complex Coronary Stenoses:

12-Month Events: Type of Revascularization

54%P<0.001

57%P=0.05


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SIRIUS of Complex Coronary Stenoses:

1-Year Medical Care Costs

D = +$309 (p=0.64)

$16,813 + 9737

$16,504 + 11,511


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SIRIUS: Cost-Effectiveness Results of Complex Coronary Stenoses:


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Summary/Conclusions of Complex Coronary Stenoses:

  • 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


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