Sirolimus-eluting versus uncoated stents in acute myocardial infarction

被引:449
作者
Spaulding, Christian
Henry, Patrick
Teiger, Emmanuel
Beatt, Kevin
Bramucci, Ezio
Carrie, Didier
Slama, Michel S.
Merkely, Bela
Erglis, Andrejs
Margheri, Massimo
Varenne, Olivier
Cebrian, Ana
Stoll, Hans-Peter
Snead, David B.
Bode, Christoph
机构
[1] Univ Paris 05, Paris Sch Med 5, Cochin Hosp, Assistance Publ Hop Paris, Paris, France
[2] INSERM, U780, Paris, France
[3] Univ Denis Diderot, Paris Sch Med 7, Lariboisiere Hosp, AP HP, Paris, France
[4] Hop Henri Mondor, AP HP, Paris Med Sch 12, F-94010 Creteil, France
[5] Hosp Rangueil, Toulouse, France
[6] Univ Paris Sud, Paris Med Sch 12, Hop Antoine Beclere, AP HP, Clamart, France
[7] Mayday Univ Hosp, London, England
[8] Policlin San Matteo, Ist Ricovero & Cura Carattere Sci, I-27100 Pavia, Italy
[9] Azienda Univ Osped Careggi, Florence, Italy
[10] Semmelweis Univ, Budapest, Hungary
[11] Pauls Stradins Univ Hosp, Riga, Latvia
[12] Cordis, Waterloo, ON, Canada
[13] Univ Freiburg, Freiburg, Germany
关键词
D O I
10.1056/NEJMoa062006
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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收藏
页码:1093 / 1104
页数:12
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