Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction.
BACKGROUND
There is no consensus regarding the safety and efficacy of drug-eluting stents, as compared with bare-metal stents, in patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI).


METHODS
We randomly assigned, in a 3:1 ratio, 3006 patients presenting with ST-segment elevation myocardial infarction to receive paclitaxel-eluting stents (2257 patients) or otherwise identical bare-metal stents (749 patients). The two primary end points of the study were the 12-month rates of target-lesion revascularization for ischemia (analysis powered for superiority) and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis (powered for noninferiority with a 3.0% margin). The major secondary end point was angiographic evidence of restenosis at 13 months.


RESULTS
Patients who received paclitaxel-eluting stents, as compared with those who received bare-metal stents, had significantly lower 12-month rates of ischemia-driven target-lesion revascularization (4.5% vs. 7.5%; hazard ratio, 0.59; 95% confidence interval [CI], 0.43 to 0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; hazard ratio, 0.65; 95% CI, 0.48 to 0.89; P=0.006), with noninferior rates of the composite safety end point (8.1% vs. 8.0%; hazard ratio, 1.02; 95% CI, 0.76 to 1.36; absolute difference, 0.1 percentage point; 95% CI, -2.1 to 2.4; P=0.01 for noninferiority; P=0.92 for superiority). Patients treated with paclitaxel-eluting stents and those treated with bare-metal stents had similar 12-month rates of death (3.5% and 3.5%, respectively; P=0.98) and stent thrombosis (3.2% and 3.4%, respectively; P=0.77). The 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; hazard ratio, 0.44; 95% CI, 0.33 to 0.57; P<0.001).


CONCLUSIONS
In patients with ST-segment elevation myocardial infarction who were undergoing primary PCI, implantation of paclitaxel-eluting stents, as compared with bare-metal stents, significantly reduced angiographic evidence of restenosis and recurrent ischemia necessitating repeat revascularization procedures. No safety concerns were apparent at 1 year. (ClinicalTrials.gov number, NCT00433966.)
Stone
Gregg W
GW
Columbia University Medical Center and New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu
Lansky
Alexandra J
AJ
Pocock
Stuart J
SJ
Gersh
Bernard J
BJ
Dangas
George
G
Wong
S Chiu
SC
Witzenbichler
Bernhard
B
Guagliumi
Giulio
G
Peruga
Jan Z
JZ
Brodie
Bruce R
BR
Dudek
Dariusz
D
Möckel
Martin
M
Ochala
Andrzej
A
Kellock
Alison
A
Parise
Helen
H
Mehran
Roxana
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000628:therapy; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D012008:Recurrence; D019233:Retreatment / Q000706:statistics & numerical data; D012306:Risk; D015607:Stents / Q000009:adverse effects; D013548:Sweden
D005343:Fibrinolytic Agents; D017239:Paclitaxel