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Cost-Effectiveness of Sirolimus Drug-Eluting Stents for Treatment of Complex Coronary Stenoses - SIRIUS Cost-effectiveness
Description:
The goal of the Cost-Effectiveness of Sirolimus Drug-Eluting Stents for Treatment of Complex Coronary Stenoses (SIRIUS) study was to determine the cost-effectiveness of sirolimus drug-eluting stents versus bare stents for the treatment of complex coronary stenoses.
Study Design
Study Design:
Patients Enrolled: 1,101
Mean Follow Up: One year
Mean Patient Age: Mean age 62 years
Female: 28
Patient Populations:
Men and women with de novo native coronary lesions requiring single-vessel treatment of higher risk lesions (2.5-3.5 mm diameter and 15-30 mm length)
Exclusions:
Recent myocardial infarction (<24 hours); unprotected left main disease; ostial location; total occlusion (TIMI 0 flow); angiographic evidence of thrombus; calcified lesion which cannot be predilated; left ventricular ejection fraction <25%; impaired renal function; pretreatment with devices other than balloon angioplasty; allergy to aspirin, clopidogrel, or ticlopidine; and prior or planned intervention within 30 days
Primary Endpoints:
Total one-year health care costs
Drug/Procedures Used:
Patients in SIRIUS were randomized to sirolimus (rapamycin) coated BX Velocity stents versus bare BX Velocity stents. Medical resource utilization and costs were assessed as part of the SIRIUS trial. Costs were assessed from the U.S. societal perspective. Each coated stent was assumed to cost $3,000/stent.
Principal Findings:
Catheterization laboratory costs were $2,856 higher in the coated stent arm compared with the bare stent arm ($7,251 vs. $4,395, p<0.001) due primarily to the increased cost of the coated stent. There was no difference in other cost utilization during the procedure, including length of procedure and number of stents placed (1.4 in each arm, p=NS). As a result of the increased cath lab costs, the overall in-hospital costs were higher in the coated stent arm ($11,345 vs. $8,464, p<0.001).
During follow-up, the rate of repeat revascularization was significantly lower in the coated stent arm (13.3% vs. 28.4%, p<0.001). As a result, costs during the follow-up were signifcantly reduced in the coated stent arm ($5,468 vs. $8,040, p<0.001). Given the offset in follow-up costs, total costs through one year (in-hospital + follow-up) did not differ significantly in the coated stent versus the bare stent arm ($16,813 vs. $16,504, p=0.64). The cost-effectiveness (C/E) ratio for coated versus bare stents was $1,650 per repeat revascularization avoided and a quality adjusted life year (QALY) of $27,540.
Interpretation:
Among patients with complex coronary stenoses, treatment with sirolimus drug-eluting stents was not associated with a significant difference in total health care costs at one-year follow-up.
Given the clinical benefits of avoided repeat revascularizations, use of sirolimus drug-eluting stents had a C/E ratio of $1,650 per repeat revascularization avoided, and a QALY of $27,540 per patient. This QALY is considered to be in the generally acceptable range of <$50,000, and comparable to other interventional procedures.
References:
Cohen DJ, et al. Cost-Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex Coronary Stenoses. Results From the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) Trial. Circulation. 2004;110:508-514.
Presented at Late-Breaking Clinical Trials, ACC 2003.
Keywords: Coronary Artery Disease, Hospital Costs, Follow-Up Studies, Coronary Stenosis, Drug-Eluting Stents, Catheterization, Sirolimus, Quality-Adjusted Life Years, Stents
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