A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease

doi:10.1056/NEJMoa032441

Volume 350:221-231		January 15, 2004		Number 3

A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease

Gregg W. Stone, M.D., Stephen G. Ellis, M.D., David A. Cox, M.D., James Hermiller, M.D., Charles O'Shaughnessy, M.D., James Tift Mann, M.D., Mark Turco, M.D., Ronald Caputo, M.D., Patrick Bergin, M.D., Joel Greenberg, M.D., Jeffrey J. Popma, M.D., Mary E. Russell, M.D., for the TAXUS-IV Investigators

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ABSTRACT

Background Restenosis after coronary stenting necessitates repeatedpercutaneous or surgical revascularization procedures. The deliveryof paclitaxel to the site of vascular injury may reduce theincidence of neointimal hyperplasia and restenosis.

Methods At 73 U.S. centers, we enrolled 1314 patients who werereceiving a stent in a single, previously untreated coronary-arterystenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10to 28 mm) in a prospective, randomized, double-blind study.A total of 652 patients were randomly assigned to receive abare-metal stent, and 662 to receive an identical-appearing,slow-release, polymer-based, paclitaxel-eluting stent. Angiographicfollow-up was prespecified at nine months in 732 patients.

Results In terms of base-line characteristics, the two groupswere well matched. Diabetes mellitus was present in 24.2 percentof patients; the mean reference-vessel diameter was 2.75 mm,and the mean lesion length was 13.4 mm. A mean of 1.08 stents(length, 21.8 mm) were implanted per patient. The rate of ischemia-driventarget-vessel revascularization at nine months was reduced from12.0 percent with the implantation of a bare-metal stent to4.7 percent with the implantation of a paclitaxel-eluting stent(relative risk, 0.39; 95 percent confidence interval, 0.26 to0.59; P<0.001). Target-lesion revascularization was requiredin 3.0 percent of the group that received a paclitaxel-elutingstent, as compared with 11.3 percent of the group that receiveda bare-metal stent (relative risk, 0.27; 95 percent confidenceinterval, 0.16 to 0.43; P<0.001). The rate of angiographicrestenosis was reduced from 26.6 percent to 7.9 percent withthe paclitaxel-eluting stent (relative risk, 0.30; 95 percentconfidence interval, 0.19 to 0.46; P<0.001). The nine-monthcomposite rates of death from cardiac causes or myocardial infarction(4.7 percent and 4.3 percent, respectively) and stent thrombosis(0.6 percent and 0.8 percent, respectively) were similar inthe group that received a paclitaxel-eluting stent and the groupthat received a bare-metal stent.

Conclusions As compared with bare-metal stents, the slow-release,polymer-based, paclitaxel-eluting stent is safe and markedlyreduces the rates of clinical and angiographic restenosis atnine months.

Source Information

From the Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York (G.W.S.); the Cleveland Clinic Foundation, Cleveland (S.G.E.); Mid Carolina Cardiology, Charlotte, N.C. (D.A.C.); St. Vincent's Hospital, Indianapolis (J.H.); Elyria Memorial Hospital, Elyria, Ohio (C.O.); WakeMed, Raleigh, N.C. (J.T.M.); Washington Adventist Hospital, Tacoma Park, Md. (M.T.); St. Joseph's Hospital, Syracuse, N.Y. (R.C.); Sacred Heart Medical Center, Eugene, Oreg. (P.B.); Florida Hospital, Orlando (J.G.); Brigham and Women's Hospital, Boston (J.J.P.); and Boston Scientific, Natick, Mass. (M.E.R.).

Address reprint requests to Dr. Stone at the Cardiovascular Research Foundation, 55 E. 59th St., 6th Fl., New York, NY 10022, or at gstone{at}crf.org.

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N Engl J Med 2004; 350:2099-2100, May 13, 2004. Correspondence

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