Paclitaxel-Eluting versus Uncoated Stents in Primary Percutaneous Coronary Intervention
Gerrit J. Laarman, M.D., Ph.D., Maarten J. Suttorp, M.D., Ph.D., Maurits T. Dirksen, M.D., Loek van Heerebeek, M.D., Ferdinand Kiemeneij, M.D., Ph.D., Ton Slagboom, M.D., L. Ron van der Wieken, M.D., Jan G.P. Tijssen, Ph.D., Benno J. Rensing, M.D., Ph.D., and Mark Patterson, M.R.C.P.
Background Drug-eluting coronary-artery stents have been shownto decrease restenosis and therefore the likelihood that additionalprocedures will be required after percutaneous coronary intervention(PCI). We evaluated the use of a drug-eluting stent in patientsundergoing PCI for acute myocardial infarction with ST-segmentelevation.
Methods We randomly assigned 619 patients presenting with anacute myocardial infarction with ST-segment elevation to receiveeither a paclitaxel-eluting stent or an uncoated stent. Theprimary end point was a composite of death from cardiac causes,recurrent myocardial infarction, or target-lesion revascularizationat 1 year.
Results Baseline clinical and angiographic characteristics inboth groups were well matched. There was a trend toward a lowerrate of serious adverse events in the paclitaxel-stent groupthan in the uncoated-stent group (8.8% vs. 12.8%; adjusted relativerisk, 0.63; 95% confidence interval, 0.37 to 1.07; P=0.09).A nonsignificant trend was also detected in favor of the paclitaxel-stentgroup, as compared with the uncoated-stent group, in the rateof 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 during1 year of follow-up was the same in both groups (1.0%).
Conclusions Although the use of paclitaxel-eluting stents inacute myocardial infarction with ST-segment elevation reducedthe incidence of serious adverse cardiac events at 1 year by4.0 percentage points, as compared with uncoated stents, thedifference was not statistically significant. (Current ControlledTrials number, ISRCTN65027270
[controlled-trials.com]
.)
Source Information
From the Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam (G.J.L., M.T.D., L.H., F.K., T.S., L.R.W., M.P.); the Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein (M.J.S., B.J.R.); and the Department of Cardiology, Academic Medical Center, Amsterdam (J.G.P.T.) all in the Netherlands.
Address reprint requests to Dr. Laarman at the Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, 1090 HM Amsterdam, the Netherlands, or at g.j.laarman{at}olvg.nl.
Drug-Eluting Stents in Primary PCI
Alfonso F., Jneid H., Maree A. O., Palacios I. F., Valgimigli M., Percoco G., Bolognese L., Spaulding C., Henry P., Teiger E., Laarman G. J., Van de Werf F.
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N Engl J Med 2006;
355:2483-2486, Dec 7, 2006.
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[Full Text]
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