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A Paclitaxel-Eluting Stent for the Prevention of Coronary Restenosis

Authors
 Seung-Jung Park  ;  Won Heum Shim  ;  Gary S. Mintz  ;  Neil J. Weissman  ;  Ricky Lam  ;  Yangsoo Jang  ;  Donghoon Choi  ;  Cheol Whan Lee  ;  Myeong-Ki Hong  ;  Seong-Wook Park  ;  Albert E. Raizner  ;  David S. Ho 
Citation
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.348(16) : 1537-1545, 2003 
Journal Title
NEW ENGLAND JOURNAL OF MEDICINE
ISSN
 0028-4793 
Issue Date
2003
MeSH
Angiogenesis Inhibitors/administration & dosage ; Angiogenesis Inhibitors/adverse effects ; Angiogenesis Inhibitors/therapeutic use* ; Angioplasty, Balloon, Coronary ; Aspirin/adverse effects ; Aspirin/therapeutic use ; Clopidogrel ; Coronary Angiography ; Coronary Disease/diagnostic imaging ; Coronary Disease/pathology ; Coronary Disease/therapy* ; Coronary Restenosis/diagnostic imaging ; Coronary Restenosis/prevention & control* ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Hyperplasia/diagnostic imaging ; Hyperplasia/prevention & control ; Male ; Middle Aged ; Paclitaxel/administration & dosage ; Paclitaxel/adverse effects ; Paclitaxel/therapeutic use* ; Platelet Aggregation Inhibitors/adverse effects ; Platelet Aggregation Inhibitors/therapeutic use ; Stents* ; Ticlopidine/adverse effects ; Ticlopidine/analogs & derivatives ; Ticlopidine/therapeutic use ; Tunica Intima/pathology ; Ultrasonography, Interventional
Keywords
12700373
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 microg per square millimeter, or high dose, 3.1 microg 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 percent vs. 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.
Files in This Item:
T200303113.pdf Download
DOI
10.1056/NEJMoa021007
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/113474
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