Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization.
BACKGROUND
Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.


METHODS
We conducted a randomized, controlled, single-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents in 1012 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (death from cardiac causes, myocardial infarction, and ischemia-driven revascularization of the target lesion) by nine months. Follow-up angiography was completed in 540 of 1012 patients (53.4 percent).


RESULTS
The two groups had similar baseline clinical and angiographic characteristics. The rate of major adverse cardiac events at nine months was 6.2 percent in the sirolimus-stent group and 10.8 percent in the paclitaxel-stent group (hazard ratio, 0.56; 95 percent confidence interval, 0.36 to 0.86; P=0.009). The difference was driven by a lower rate of target-lesion revascularization in the sirolimus-stent group than in the paclitaxel-stent group (4.8 percent vs. 8.3 percent; hazard ratio, 0.56; 95 percent confidence interval, 0.34 to 0.93; P=0.03). Rates of death from cardiac causes were 0.6 percent in the sirolimus-stent group and 1.6 percent in the paclitaxel-stent group (P=0.15); the rates of myocardial infarction were 2.8 percent and 3.5 percent, respectively (P=0.49); and the rates of angiographic restenosis were 6.6 percent and 11.7 percent, respectively (P=0.02).


CONCLUSIONS
As compared with paclitaxel-eluting stents, the use of sirolimus-eluting stents results in fewer major adverse cardiac events, primarily by decreasing the rates of clinical and angiographic restenosis.
Windecker
Stephan
S
Department of Cardiology, University Hospital Bern, Bern, Switzerland. stephan.windecker@insel.ch
Remondino
Andrea
A
Eberli
Franz R
FR
Jüni
Peter
P
Räber
Lorenz
L
Wenaweser
Peter
P
Togni
Mario
M
Billinger
Michael
M
Tüller
David
D
Seiler
Christian
C
Roffi
Marco
M
Corti
Roberto
R
Sütsch
Gabor
G
Maier
Willibald
W
Lüscher
Thomas
T
Hess
Otto M
OM
Egger
Matthias
M
Meier
Bernhard
B
D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control* / 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*; D016016:Proportional Hazards Models; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016019:Survival Analysis
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus