Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.
BACKGROUND
Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization.


METHODS
We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days.


RESULTS
The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined.


CONCLUSIONS
In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed.
Moses
Jeffrey W
JW
Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute of New York, New York 10021, USA. jmoses@lenoxhill.net
Leon
Martin B
MB
Popma
Jeffrey J
JJ
Fitzgerald
Peter J
PJ
Holmes
David R
DR
O'Shaughnessy
Charles
C
Caputo
Ronald P
RP
Kereiakes
Dean J
DJ
Williams
David O
DO
Teirstein
Paul S
PS
Jaeger
Judith L
JL
Kuntz
Richard E
RE
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D023903:Coronary Restenosis / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000150:complications / Q000401:mortality / Q000628:therapy*; D048909:Diabetes Complications; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction; D020123:Sirolimus / Q000627:therapeutic use*; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D007166:Immunosuppressive Agents; D020123:Sirolimus