Sirolimus-eluting versus bare-metal stents for the reduction of coronary restenosis: 18-month angiographic results from the GERSHWIN Study.
OBJECTIVE
The GERSHWIN study (German Stent Health Outcome and Economics Within Normal Practice) was designed to evaluate long-term effects of treatment of coronary artery disease (CAD) with sirolimus-eluting stents (SES), as compared to bare-metal stents (BMS).


METHODS
Within a multicenter, prospective intervention study in 35 hospitals throughout Germany, CAD patients with coronary stenosis and elective percutaneous coronary intervention (PCI) indication were treated either with SES or BMS (sequential control design with a case-to-control ratio of 2 : 1). Standardized questionnaires were completed by patients and their physicians at baseline, 3, 6, 12, and 18 months following PCI to document re-PCI for restenosis, myocardial infarction (MI), coronary bypass surgery (CABG), and death. Angiographic PCI documentation was evaluated by an independent expert.


RESULTS
From April 2003 until June 2005, 658 patients were treated with SES (mean age 63 +/- 9 years, 87% male) and 294 patients with BMS (mean age 64 +/- 10 years, 79% male). Significant baseline differences were found by age, gender, household status, three vessel disease, and number of implanted stents. After 18 months, 8% of the SES versus 17% of the BMS group had undergone target vessel revascularization (p adjusted < 0.0001). There were no significant differences between BMS and SES regarding MI, CABG, or death. Re-PCI of target and new non-target vessel lesions was performed at a significantly lower degree of stenosis in SES than in BMS.


CONCLUSIONS
Compared to patients with BMS, patients with implantation of SES experienced considerably fewer target vessel revascularizations. The threshold to perform re-PCI appeared lower in SES than in BMS. An extended evaluation of the effects of SES will be available from the 3-year follow-up of the GERSHWIN study.
Brüggenjürgen
Bernd
B
Institute for Social Medicine, Epidemiology and Health Economics, Charité - University Medicine, Berlin, Germany. bernd.brueggenjuergen@charite.de
McBride
Doreen
D
Bode
Christoph
C
Hamm
Christian W
CW
Kuck
Karl-Heinz
KH
Willich
Stefan N
SN
D000792:Angiography / Q000706:statistics & numerical data; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology* / Q000517:prevention & control*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D005260:Female; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D015994:Incidence; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000706:statistics & numerical data*; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D020123:Sirolimus