Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients.
BACKGROUND
Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis. It is not known whether there are differences in the effectiveness of currently approved drug-eluting stents in the high-risk subgroup of patients with diabetes mellitus.


METHODS
We enrolled 250 patients with diabetes and coronary artery disease: 125 were randomly assigned to receive paclitaxel-eluting stents, and 125 to receive sirolimus-eluting stents. The primary end point was in-segment late luminal loss. Secondary end points were angiographic restenosis (defined as in-segment stenosis of at least 50 percent at follow-up angiography) and the need for revascularization of the target lesion during a nine-month follow-up period. The study was designed to show noninferiority of the paclitaxel stent as compared with the sirolimus stent, defined as a difference in the extent of in-segment late luminal loss of no more than 0.16 mm.


RESULTS
The extent of in-segment late luminal loss was 0.24 mm (95 percent confidence interval, 0.09 to 0.39) greater in the paclitaxel-stent group than in the sirolimus-stent group (P=0.002). In-segment restenosis was identified on follow-up angiography in 16.5 percent of the patients in the paclitaxel-stent group and 6.9 percent of the patients in the sirolimus-stent group (P=0.03). Target-lesion revascularization was performed in 12.0 percent of the patients in the paclitaxel-stent group and 6.4 percent of the patients in the sirolimus-stent group (P=0.13).


CONCLUSIONS
In patients with diabetes mellitus and coronary artery disease, use of the sirolimus-eluting stent is associated with a decrease in the extent of late luminal loss, as compared with use of the paclitaxel-eluting stent, suggesting a reduced risk of restenosis.
Dibra
Alban
A
Deutsches Herzzentrum, Technische Universität, Munich, Germany.
Kastrati
Adnan
A
Mehilli
Julinda
J
Pache
Jürgen
J
Schühlen
Helmut
H
von Beckerath
Nicolas
N
Ulm
Kurt
K
Wessely
Rainer
R
Dirschinger
Josef
J
Schömig
Albert
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy; D048909:Diabetes Complications / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage*; D012044:Regression Analysis; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016019:Survival Analysis
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus