Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention.
BACKGROUND
Drug-eluting coronary-artery stents have been shown to decrease restenosis and therefore the likelihood that additional procedures will be required after percutaneous coronary intervention (PCI). We evaluated the use of a drug-eluting stent in patients undergoing PCI for acute myocardial infarction with ST-segment elevation.


METHODS
We randomly assigned 619 patients presenting with an acute myocardial infarction with ST-segment elevation to receive either a paclitaxel-eluting stent or an uncoated stent. The primary end point was a composite of death from cardiac causes, recurrent myocardial infarction, or target-lesion revascularization at 1 year.


RESULTS
Baseline clinical and angiographic characteristics in both groups were well matched. There was a trend toward a lower rate of serious adverse events in the paclitaxel-stent group than in the uncoated-stent group (8.8% vs. 12.8%; adjusted relative risk, 0.63; 95% confidence interval, 0.37 to 1.07; P=0.09). A nonsignificant trend was also detected in favor of the paclitaxel-stent group, as compared with the uncoated-stent group, in the rate of death from cardiac causes or recurrent myocardial infarction (5.5% vs. 7.2%, P=0.40) and in the rate of target-lesion revascularization (5.3% vs. 7.8%, P=0.23). The incidence of stent thrombosis during 1 year of follow-up was the same in both groups (1.0%).


CONCLUSIONS
Although the use of paclitaxel-eluting stents in acute myocardial infarction with ST-segment elevation reduced the incidence of serious adverse cardiac events at 1 year by 4.0 percentage points, as compared with uncoated stents, the difference was not statistically significant. (Current Controlled Trials number, ISRCTN65027270 [controlled-trials.com].).
Laarman
Gerrit J
GJ
Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. g.j.laarman@olvg.nl
Suttorp
Maarten J
MJ
Dirksen
Maurits T
MT
van Heerebeek
Loek
L
Kiemeneij
Ferdinand
F
Slagboom
Ton
T
van der Wieken
L Ron
LR
Tijssen
Jan G P
JG
Rensing
Benno J
BJ
Patterson
Mark
M
D015906:Angioplasty, Balloon, Coronary; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D016016:Proportional Hazards Models; D012306:Risk; D055502:Secondary Prevention; D016037:Single-Blind Method; D015607:Stents; D013927:Thrombosis / Q000453:epidemiology
D007166:Immunosuppressive Agents; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D017239:Paclitaxel