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 language | English |
|---|---|
| Pages (from-to) | 1537-1545 |
| Number of pages | 9 |
| Journal | New England Journal of Medicine |
| Volume | 348 |
| Issue number | 16 |
| DOIs | |
| Publication status | Published - 2003 Apr 17 |
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All Science Journal Classification (ASJC) codes
- Medicine(all)
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A paclitaxel-eluting stent for the prevention of coronary restenosis. / Park, Seung Jung; Shim, Won Heum; Ho, David S.; Raizner, Albert E.; Park, Seong Wook; Hong, Myeongki; Lee, Cheol Whan; Choi, Donghoon; Jang, Yangsoo; Lam, Ricky; Weissman, Neil J.; Mintz, Gary S.
In: New England Journal of Medicine, Vol. 348, No. 16, 17.04.2003, p. 1537-1545.Research output: Contribution to journal › Article
TY - JOUR
T1 - A paclitaxel-eluting stent for the prevention of coronary restenosis
AU - Park, Seung Jung
AU - Shim, Won Heum
AU - Ho, David S.
AU - Raizner, Albert E.
AU - Park, Seong Wook
AU - Hong, Myeongki
AU - Lee, Cheol Whan
AU - Choi, Donghoon
AU - Jang, Yangsoo
AU - Lam, Ricky
AU - Weissman, Neil J.
AU - Mintz, Gary S.
PY - 2003/4/17
Y1 - 2003/4/17
N2 - 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.
AB - 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.
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U2 - 10.1056/NEJMoa021007
DO - 10.1056/NEJMoa021007
M3 - Article
VL - 348
SP - 1537
EP - 1545
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 16
ER -