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Previous Volume 355:1093-1104 September 14, 2006 Number 11 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Van de Werf, F. 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 Sirolimus-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of such stents in primary percutaneous coronary intervention (PCI) for acute myocardial infarction with ST-segment elevation.

Methods We performed a single-blind, multicenter, prospectively randomized trial to compare sirolimus-eluting stents with uncoated stents in primary PCI for acute myocardial infarction with ST-segment elevation. The trial included 712 patients at 48 medical centers. The primary end point was target-vessel failure at 1 year after the procedure, defined as target-vessel–related death, recurrent myocardial infarction, or target-vessel revascularization. A follow-up angiographic substudy was performed at 8 months among 174 patients from selected centers.

Results The rate of the primary end point was significantly lower in the sirolimus-stent group than in the uncoated-stent group (7.3% vs. 14.3%, P=0.004). This reduction was driven by a decrease in the rate of target-vessel revascularization (5.6% and 13.4%, respectively; P<0.001). There was no significant difference between the two groups in the rate of death (2.3% and 2.2%, respectively; P=1.00), reinfarction (1.1% and 1.4%, respectively; P=1.00), or stent thrombosis (3.4% and 3.6%, respectively; P=1.00). The degree of neointimal proliferation, as assessed by the mean (±SD) in-stent late luminal loss, was significantly lower in the sirolimus-stent group (0.14±0.49 mm, vs. 0.83±0.52 mm in the uncoated stent group; P<0.001).

Conclusions Among selected patients with acute myocardial infarction, the use of sirolimus-eluting stents significantly reduced the rate of target-vessel revascularization at 1 year. (ClinicalTrials.gov number, NCT00232830 [ClinicalTrials.gov] .)

Source Information

From Assistance Publique–Hôpitaux de Paris (AP–HP) Cochin Hospital, Paris 5 Medical School Rene Descartes University and INSERM U780, Paris (C.S., O.V.); AP–HP Lariboisiere Hospital, Paris 7 Medical School University Denis Diderot, Paris (P.H.); AP–HP Henri Mondor Hospital, Paris 12 Medical School, Créteil (E.T.); Hospital Rangueil, Toulouse (D.C.); and AP–HP Antoine Béclère Hospital, Paris 12 Medical School Paris Sud University, Clamart (M.S.S.) — all in France; Mayday University Hospital, London (K.B.); Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia (E.B.), and Azienda Universitaria Ospedaliera Careggi, Florence (M.M.) — both in Italy; Semmelweis University, Budapest (B.M.); Pauls Stradins University Hospital, Riga, Latvia (A.E.); Cordis (Johnson & Johnson), Waterloo, Belgium (A.C., H.-P.S.) and Warren, NJ (D.B.S.); and the University of Freiburg, Freiburg, Germany (C.B.).

Address reprint requests to Dr. Spaulding at Cochin Hospital, 27 rue du Faubourg St. Jacques, 75014 Paris, or at christian.spaulding{at}cch.ap-hop-paris.fr.

Full Text of this Article

Related Letters:

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.
Extract | Full Text | PDF  
N Engl J Med 2006; 355:2483-2486, Dec 7, 2006. Correspondence

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