Abstract 2166: Sirolimus-eluting Versus Bare-metal Stents for the Reduction of Coronary Restenosis: Outcome and Economic Analysis of the GERSHWIN Study
Background: The GERSHWIN Study (German Stent Health Outcome and Economics Within Normal Practice) was designed to evaluate long-term outcome and economic implications of drug-eluting sirolimus stents (SES) vs. bare-metal stents (BMS) in the treatment of coronary artery disease (CAD).
Methods: In this prospective intervention study in 35 hospitals in Germany, CAD patients undergoing elective PCI were treated with BMS or SES (sequential control design with case : control ratio of 2 : 1). Standardized questionnaires were completed by patients and their physicians at 3, 6, 12 and 18 months following PCI to document major adverse cardiac events (MACE) including death, myocardial infarction, coronary bypass surgery and intervention for restenosis, as well as disease-related direct and indirect costs. Patient health-related and disease-specific quality of life was assessed with the SF-36 and MacNew heart disease questionnaires.
Results: From April 2003 until June 2005, 658 patients were treated with SES (mean age 63±9, 87% male) and 294 patients with BMS (mean age 64±10, 79% male). After 18 months, 13% of the SES vs. 20% of the BMS group had suffered MACE (p adjusted <0.01). The initial hospital costs were higher associated with SES than with BMS (6,001±57 vs. 3,913±69 Euro, p adjusted <0.01), and the respective 18-month follow-up direct and indirect costs were similar (7,949±462 vs. 8,360±554 Euro, p=ns). Overall, disease-related costs over 18 months were higher in the SES compared to BMS group: 13,950±468 vs. 12,273±562, p<0.01. Quality of life (MacNew) was significantly higher in SES compared to BMS patients 6 and 12 months after PCI, but not significantly different 18 months after PCI.
Conclusions: In comparison to patients with BMS, patients with implantation of SES experienced considerably fewer MACE during 18-month follow-up. The higher initial cost associated with SES compared to BMS were followed by similar economic consequences in both groups during 18-month follow-up.