Abstract 3250: 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 (DES) 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 DES (sequential control design with case : control ratio of 2 :
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, and 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 May 2005, 602 patients were treated with DES (mean age 63±9, 87% male) and 295 patients with BMS (mean age 65±10, 79% male). After 12 months, 18% of the DES vs. 30% of the BMS group had suffered MACE (p adjusted <0.05). The initial hospital costs were higher associated with DES than with BMS (5,881±56 vs. 3,791±59 Euro), but the respective 12-month follow-up direct and indirect costs were lower (5,679±384 vs. 5,931±400 Euro and 635±268 vs. 1,506±279 Euro). Overall, disease-related costs were similar in both groups (DES 12,190±502, BMS 11,231±523, p = ns). Quality of life was significantly higher in DES compared to BMS patients 6 and 12 months after PCI.
Conclusions: In comparison to patients with BMS, patients with implantation of DES experienced considerably fewer MACE during 12-month follow-up. Despite the higher initial cost associated with DES compared to BMS, the overall costs in the 12 months following PCI were similar.