Sirolimus eluting stent (Cypher) in patients with diabetes mellitus: results from the German Cypher Stent Registry.
BACKGROUND
Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary.


RESULTS
1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS).


CONCLUSIONS
The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.
Department of Internal Medicine, Frankenwaldklinik Kronach, Kronach, Germany. frank.weber@frankenwaldklinik.de
Frank D
FD
Weber
Henrik
H
Schneider
Marcus
M
Wiemer
Thomas
T
Pfannebecker
Ulrich
U
Tebbe
Christian W
CW
Hamm
Jochen
J
Senges
Steffen
S
Schneider
Christoph A
CA
Nienaber
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000191:economics / Q000379:methods* / Q000401:mortality; D016022:Case-Control Studies; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D003362:Cost-Benefit Analysis; D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000188:drug therapy; D003925:Diabetic Angiopathies / Q000150:complications / Q000175:diagnosis; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000191:economics*; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage*; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
D020123:Sirolimus