Highlights from the American College of Cardiology Annual Scientific Sessions 2003: March 28 to april 2, 2003

Article Outline

• Session
  • Late-breaking clinical trials
    • Study
    • Presenter
    • Background
    • Results
    • Interpretation

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Session 

Late-breaking clinical trials 

Published online June 10, 2003.Am Heart J 2003;146:19-26. Cost-effectiveness of sirolimus drug-eluting stents for the treatment of complex coronary stenoses: Results from the randomized SIRIUS trial

Dr David J. Cohen, Beth Israel Deaconess Medical Center and Harvard Clinical Research Institute, Boston, Mass

Clinical trials have demonstrated that sirolimus drug-eluting coronary artery stents (DES) dramatically reduce clinical and angiographic restenosis compared with conventional stents. Although current projections place the price of DES at approximately 2 to 3 times the price of a conventional stent, their use could result in cost savings if the need for repeat procedures is reduced. The aims of this study were 3-fold: 1) to compare the inhospital and long-term costs of percutaneous coronary intervention (PCI) using the DES with those of PCI using a conventional stent; 2) to examine the overall cost-effectiveness of the DES compared with conventional stenting in patients undergoing “real-world” PCI of coronary lesions; and 3) to examine the impact of clinical restenosis on the long-term costs of care for patients undergoing PCI in contemporary practice.

Medical resource utilization and costs were measured prospectively for 1100 patients randomized in the SIRIUS trial of sirolimus-eluting stents versus bare metal stents. The price of each sirolimus-eluting stent was estimated to be $3000 US. Index procedure costs, initial hospital costs, discharge-to-1-year costs, and total 1-year costs were compared. Acceptable US societal threshold costs per repeat revascularization avoided and per quality-adjusted life year (QALY) were estimated at <$10,000 and <$50,000, respectively. For the base case analysis, investigators assumed that patients in the conventional stent group would receive 1 month of antiplatelet therapy (clopidogrel) compared with 3 months in the DES group. Sensitivity analyses were conducted assuming 9 months of clopidogrel therapy for both groups.

Table I summarizes the costs for the DES compared with the conventional stent. The use of the DES resulted in a 62% reduction in restenosis compared with conventional stenting. Although the DES resulted in higher index procedure and initial hospital costs, total 1-year costs were not significantly different. This was due to cost savings with the DES during the discharge-to-1-year period. The cost-effectiveness ratio for DES compared with conventional stenting was ∼$1650 per repeat revascularization avoided or ∼$27,500 per QALY gained.

Table I. Summary of economic outcomes

NS, Not significant.

This study demonstrates that despite the higher up-front costs with the use of DES compared with conventional stents, the dramatic reduction in restenosis results in similar total 1-year costs and reasonable cost-effectiveness ratios.

This eagerly-awaited analysis shows that DES is highly cost-effective in the population studied when compared with other accepted therapies, such as hemodialysis for end-stage renal disease ($50,000 per QALY gained) and tissue plasminogen activator for acute ST-elevation myocadial infarction ($32,678 per QALY gained). Further research is needed to determine if these results apply to patients with more complicated coronary artery disease such as saphenous-vein graft disease and multivessel disease.