A Paclitaxel-Eluting Stent for the Prevention of Coronary Restenosis
Seung-Jung Park, M.D., Ph.D., Won Heum Shim, M.D., Ph.D., David S. Ho, M.B., B.S., Ph.D., Albert E. Raizner, M.D., Seong-Wook Park, M.D., Ph.D., Myeong-Ki Hong, M.D., Ph.D., Cheol Whan Lee, M.D., Ph.D., Donghoon Choi, M.D., Yangsoo Jang, M.D., Ph.D., Ricky Lam, M.D., Neil J. Weissman, M.D., and Gary S. Mintz, M.D.
Background Intimal hyperplasia and resulting restenosis limitthe efficacy of coronary stenting. We studied a coronary stentcoated with the antiproliferative agent paclitaxel as a meansof preventing restenosis.
Methods We conducted a multicenter, randomized, controlled,triple-blind study to evaluate the ability of a paclitaxel-elutingstent to inhibit restenosis. At three centers, 177 patientswith discrete coronary lesions (<15 mm in length, 2.25 to3.5 mm in diameter) underwent implantation of paclitaxel-elutingstents (low dose, 1.3 µg per square millimeter, or highdose, 3.1 µg per square millimeter) or control stents.Antiplatelet therapies included aspirin with ticlopidine (120patients), clopidogrel (18 patients), or cilostazol (37 patients).Clinical follow-up was performed at one month and four to sixmonths, and angiographic follow-up at four to six months.
Results Technical success was achieved in 99 percent of thepatients (176 of 177). At follow-up, the high-dose group, ascompared with the control group, had significantly better resultsfor the degree of stenosis (mean [±SD], 14±21percent vs. 39±27 percent; P<0.001), late loss ofluminal diameter (0.29±0.72 mm vs. 1.04±0.83 mm,P<0.001), and restenosis of more than 50 percent (4 percentvs. 27 percent, P<0.001). Intravascular ultrasound analysisdemonstrated a dose-dependent reduction in the volume of intimalhyperplasia (31, 18, and 13 mm3, in the high-dose, low-dose,and control groups, respectively). There was a higher rate ofmajor cardiac events in patients receiving cilostazol than inthose receiving ticlopidine or clopidogrel. Among patients receivingticlopidine or clopidogrel, event-free survival was 98 percentand 100 percent in the high-dose and control groups, respectively,at one month, and 96 percent in both at four to six months.
Conclusions Paclitaxel-eluting stents used with conventionalantiplatelet therapy effectively inhibit restenosis and neointimalhyperplasia, with a safety profile similar to that of standardstents.
Source Information
From the Asan Medical Center (S.-J.P., S.-W.P., M.-K.H., C.W.L.) and Yonsei Medical Center (W.H.S., D.C., Y.J.) — both in Seoul, South Korea; the University of Hong Kong, Hong Kong, China (D.S.H., R.L.); the Cardiovascular Angiography Analysis Laboratory, Houston (A.E.R.); the Cardiovascular Research Institute, Washington Hospital Center, Washington, D.C. (N.J.W.); and the Cardiovascular Research Foundation, New York (G.S.M.).
Address reprint requests to Dr. Seung-Jung Park at the Asan Medical Center, Division of Cardiology, 388-1 Poongnap-dong, Songpa-ku, Seoul 138-736, South Korea, or at sjpark{at}amc.seoul.kr.
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