A paclitaxel-eluting stent for the prevention of coronary restenosis

Seung Jung Park, Won Heum Shim, David S. Ho, Albert E. Raizner, Seong Wook Park, Myeong Ki Hong, Cheol Whan Lee, Donghoon Choi, Yangsoo Jang, Ricky Lam, Neil J. Weissman, Gary S. Mintz

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Abstract

BACKGROUND: Intimal hyperplasia and resulting restenosis limit the efficacy of coronary stenting. We studied a coronary stent coated with the antiproliferative agent paclitaxel as a means of preventing restenosis. METHODS: We conducted a multicenter, randomized, controlled, triple-blind study to evaluate the ability of a paclitaxel-eluting stent to inhibit restenosis. At three centers, 177 patients with discrete coronary lesions (<15 mm in length, 2.25 to 3.5 mm in diameter) underwent implantation of paclitaxel-eluting stents (low dose, 1.3 μg per square millimeter, or high dose, 3.1 μg per square millimeter) or control stents. Antiplatelet therapies included aspirin with ticlopidine (120 patients), clopidogrel (18 patients), or cilostazol (37 patients). Clinical follow-up was performed at one month and four to six months, and angiographic follow-up at four to six months. RESULTS: Technical success was achieved in 99 percent of the patients (176 of 177). At follow-up, the high-dose group, as compared with the control group, had significantly better results for the degree of stenosis (mean [±SD], 14±21 percent vs. 39±27 percent; P<0.001), late loss of luminal 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 analysis demonstrated a dose-dependent reduction in the volume of intimal hyperplasia (31, 18, and 13 mm3, in the high-dose, low-dose, and control groups, respectively). There was a higher rate of major cardiac events in patients receiving cilostazol than in those receiving ticlopidine or clopidogrel. Among patients receiving ticlopidine or clopidogrel, event-free survival was 98 percent and 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 conventional antiplatelet therapy effectively inhibit restenosis and neointimal hyperplasia, with a safety profile similar to that of standard stents.

Original languageEnglish
Pages (from-to)1537-1545
Number of pages9
JournalNew England Journal of Medicine
Volume348
Issue number16
DOIs
Publication statusPublished - 2003 Apr 17

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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    Park, S. J., Shim, W. H., Ho, D. S., Raizner, A. E., Park, S. W., Hong, M. K., Lee, C. W., Choi, D., Jang, Y., Lam, R., Weissman, N. J., & Mintz, G. S. (2003). A paclitaxel-eluting stent for the prevention of coronary restenosis. New England Journal of Medicine, 348(16), 1537-1545. https://doi.org/10.1056/NEJMoa021007