A paclitaxel-eluting stent for the prevention of coronary restenosis.
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.
Park
Seung-Jung
SJ
Asan Medical Center, Seoul, South Korea. sjpark@amc.seoul.kr
Shim
Won Heum
WH
Ho
David S
DS
Raizner
Albert E
AE
Park
Seong-Wook
SW
Hong
Myeong-Ki
MK
Lee
Cheol Whan
CW
Choi
Donghoon
D
Jang
Yangsoo
Y
Lam
Ricky
R
Weissman
Neil J
NJ
Mintz
Gary S
GS
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015906:Angioplasty, Balloon, Coronary; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use; D000077144:Clopidogrel; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006965:Hyperplasia / Q000000981:diagnostic imaging / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D015607:Stents; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D017539:Tunica Intima / Q000473:pathology; D018084:Ultrasonography, Interventional
D020533:Angiogenesis Inhibitors; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel; D001241:Aspirin