Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery

doi:10.1056/NEJMoa035071

Volume 349:1315-1323		October 2, 2003		Number 14

Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery

Jeffrey W. Moses, M.D., Martin B. Leon, M.D., Jeffrey J. Popma, M.D., Peter J. Fitzgerald, M.D., Ph.D., David R. Holmes, M.D., Charles O'Shaughnessy, M.D., Ronald P. Caputo, M.D., Dean J. Kereiakes, M.D., David O. Williams, M.D., Paul S. Teirstein, M.D., Judith L. Jaeger, B.A., Richard E. Kuntz, M.D., for the SIRIUS Investigators

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ABSTRACT

Background Preliminary reports of studies involving simple coronarylesions indicate that a sirolimus-eluting stent significantlyreduces the risk of restenosis after percutaneous coronary revascularization.

Methods We conducted a randomized, double-blind trial comparinga sirolimus-eluting stent with a standard stent in 1058 patientsat 53 centers in the United States who had a newly diagnosedlesion in a native coronary artery. The coronary disease inthese patients was complex because of the frequent presenceof diabetes (in 26 percent of patients), the high percentageof patients with longer lesions (mean, 14.4 mm), and small vessels(mean, 2.80 mm). The primary end point was failure of the targetvessel (a composite of death from cardiac causes, myocardialinfarction, and repeated percutaneous or surgical revascularizationof the target vessel) within 270 days.

Results The rate of failure of the target vessel was reducedfrom 21.0 percent with a standard stent to 8.6 percent witha sirolimus-eluting stent (P<0.001) — a reduction thatwas driven largely by a decrease in the frequency of the needfor revascularization of the target lesion (16.6 percent inthe standard-stent group vs. 4.1 percent in the sirolimus-stentgroup, P<0.001). The frequency of neointimal hyperplasiawithin the stent was also decreased in the group that receivedsirolimus-eluting stents, as assessed by both angiography andintravascular ultrasonography. Subgroup analyses revealed areduction in the rates of angiographic restenosis and target-lesionrevascularization in all subgroups examined.

Conclusions In this randomized clinical trial involving patientswith complex coronary lesions, the use of a sirolimus-elutingstent had a consistent treatment effect, reducing the ratesof restenosis and associated clinical events in all subgroupsanalyzed.

Source Information

From the Lenox Hill Heart and Vascular Institute of New York, New York (J.W.M., M.B.L.); Brigham and Women's Hospital, Boston (J.J.P., R.E.K.); Stanford University Medical Center, Stanford, Calif. (P.J.F.); the Mayo Clinic, Rochester, Minn. (D.R.H.); the North Ohio Heart Center, Elyria (C.O.); Saint Joseph's Hospital, Syracuse, N.Y. (R.P.C.); the Christ Hospital–Lindner Research Center, Cincinnati (D.J.K.); Rhode Island Hospital, Providence (D.O.W.); the Scripps Clinic, La Jolla, Calif. (P.S.T.); and Cordis (Johnson & Johnson), Warren, N.J. (J.L.J.).

Address reprint requests to Dr. Moses at the Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute of New York City, 130 E. 77th St., Black Hall, 9th Fl., New York, NY 10021, or at jmoses{at}lenoxhill.net.

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Sirolimus-Eluting Coronary Stents
Mack M. J., Drenth D. J., Zijlstra F., Boonstra P. W., Moses J. W., Leon M. B.
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N Engl J Med 2004; 350:413-414, Jan 22, 2004. Correspondence

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