Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy.
BACKGROUND
Randomized clinical trials have shown that a sirolimus-eluting stent significantly reduces restenosis after percutaneous coronary revascularization. Diabetic patients are known to have a higher risk of restenosis compared with nondiabetic patients. The purpose of this analysis was to determine the impact of sirolimus-eluting stents on outcomes of diabetic compared with nondiabetic patients.


RESULTS
The SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) trial is a randomized, double-blind study that compared sirolimus-eluting and bare metal stent implantation in 1058 patients with de novo native coronary artery lesions. Diabetes mellitus was present in 279 (26%) patients (diabetes mellitus group, 131 patients received sirolimus-eluting stents and 148 patients received bare metal stents) and was absent in 778 patients (no-diabetes mellitus group, 402 patients received sirolimus-eluting stents and 376 patients received bare metal stents). At 270 days, target lesion revascularization was reduced in diabetic patients from 22.3% with bare metal stents to 6.9% with sirolimus-eluting stents (P<0.001) and in nondiabetic patients from 14.1% to 2.99% (P<0.001), respectively. Major adverse cardiac events were reduced in diabetic patients from 25% with bare metal stents to 9.2% with sirolimus-eluting stents (P<0.001) and from 16.5% to 6.5% (P<0.001) in nondiabetic patients, respectively.


CONCLUSIONS
Implantation of sirolimus-eluting stents compared with bare metal stents in de novo coronary lesions reduces major adverse cardiac events in patients with and without diabetes mellitus. However, among patients receiving sirolimus-eluting stents, there remains a trend toward a higher frequency of repeat intervention in diabetic patients compared with nondiabetic patients, particularly in the insulin-requiring patients.
Moussa
Issam
I
Lenox Hill Heart and Vascular Institute and Cardiovascular Research Foundation, 130 East 77th St, 9th Floor, New York, NY 10021, USA. imoussa@lenoxhill.net
Leon
Martin B
MB
Baim
Donald S
DS
O'Neill
William W
WW
Popma
Jeffery J
JJ
Buchbinder
Maurice
M
Midwall
Jay
J
Simonton
Charles A
CA
Keim
Emily
E
Wang
Patrick
P
Kuntz
Richard E
RE
Moses
Jeffrey W
JW
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000150:complications / Q000188:drug therapy / Q000628:therapy*; D048909:Diabetes Complications; D003920:Diabetes Mellitus / Q000178:diet therapy / Q000188:drug therapy; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D006131:Growth Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000150:complications; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D015994:Incidence; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009026:Mortality; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D015607:Stents / Q000706:statistics & numerical data; D016896:Treatment Outcome
D000925:Anticoagulants; D004343:Drug Implants; D006131:Growth Inhibitors; D007166:Immunosuppressive Agents; D007328:Insulin; D020123:Sirolimus