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Previous Volume 353:663-670 August 18, 2005 Number 7 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Moliterno, D. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis. It is not known whether there are differences in the effectiveness of currently approved drug-eluting stents in the high-risk subgroup of patients with diabetes mellitus.

Methods We enrolled 250 patients with diabetes and coronary artery disease: 125 were randomly assigned to receive paclitaxel-eluting stents, and 125 to receive sirolimus-eluting stents. The primary end point was in-segment late luminal loss. Secondary end points were angiographic restenosis (defined as in-segment stenosis of at least 50 percent at follow-up angiography) and the need for revascularization of the target lesion during a nine-month follow-up period. The study was designed to show noninferiority of the paclitaxel stent as compared with the sirolimus stent, defined as a difference in the extent of in-segment late luminal loss of no more than 0.16 mm.

Results The extent of in-segment late luminal loss was 0.24 mm (95 percent confidence interval, 0.09 to 0.39) greater in the paclitaxel-stent group than in the sirolimus-stent group (P=0.002). In-segment restenosis was identified on follow-up angiography in 16.5 percent of the patients in the paclitaxel-stent group and 6.9 percent of the patients in the sirolimus-stent group (P=0.03). Target-lesion revascularization was performed in 12.0 percent of the patients in the paclitaxel-stent group and 6.4 percent of the patients in the sirolimus-stent group (P=0.13).

Conclusions In patients with diabetes mellitus and coronary artery disease, use of the sirolimus-eluting stent is associated with a decrease in the extent of late luminal loss, as compared with use of the paclitaxel-eluting stent, suggesting a reduced risk of restenosis.

Source Information

From Deutsches Herzzentrum (A.D., A.K., J.M., J.P., N.B., R.W., A.S.), First Medizinische Klinik rechts der Isar (H.S., J.D., A.S.), and Institut für Medizinische Statistik und Epidemiologie (K.U.), Technische Universität — all in Munich, Germany.

Address reprint requests to Dr. Kastrati at Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany, or at kastrati{at}dhm.mhn.de.

Full Text of this Article

Related Letters:

Drug-Eluting Coronary Stents
Alarcón J. A., Arribas J. M., Ruiz V., Czupryniak L., Pawlowski M., Loba J., Bonvini R. F., Verin V., Waksman R., Wolfram R. M., Jneid H., Jang I.-K., Palacios I., Kastrati A., Dibra A., Schömig A., Windecker S., Jüni P., Meier B., Moliterno D. J.
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N Engl J Med 2005; 353:2404-2408, Dec 1, 2005. Correspondence

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