Sirolimus-Eluting versus Uncoated Stents in Acute Myocardial Infarction
Christian Spaulding, M.D., Patrick Henry, M.D., Ph.D., Emmanuel Teiger, M.D., Ph.D., Kevin Beatt, M.B., B.S., Ph.D., Ezio Bramucci, M.D., Didier Carrié, M.D., Michel S. Slama, M.D., Bela Merkely, M.D., Ph.D., Andrejs Erglis, M.D., Ph.D., Massimo Margheri, M.D., Olivier Varenne, M.D., Ph.D., Ana Cebrian, Ph.D., Hans-Peter Stoll, M.D., David B. Snead, Ph.D., Christoph Bode, M.D., for the TYPHOON Investigators
Background Sirolimus-eluting stents reduce rates of restenosisand reintervention, as compared with uncoated stents. Data arelimited regarding the safety and efficacy of such stents inprimary percutaneous coronary intervention (PCI) for acute myocardialinfarction with ST-segment elevation.
Methods We performed a single-blind, multicenter, prospectivelyrandomized trial to compare sirolimus-eluting stents with uncoatedstents in primary PCI for acute myocardial infarction with ST-segmentelevation. The trial included 712 patients at 48 medical centers.The primary end point was target-vessel failure at 1 year afterthe procedure, defined as target-vessel–related death,recurrent myocardial infarction, or target-vessel revascularization.A follow-up angiographic substudy was performed at 8 monthsamong 174 patients from selected centers.
Results The rate of the primary end point was significantlylower in the sirolimus-stent group than in the uncoated-stentgroup (7.3% vs. 14.3%, P=0.004). This reduction was driven bya decrease in the rate of target-vessel revascularization (5.6%and 13.4%, respectively; P<0.001). There was no significantdifference 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 assessedby the mean (±SD) in-stent late luminal loss, was significantlylower 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 therate of target-vessel revascularization at 1 year. (ClinicalTrials.govnumber, 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.
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.
Correspondence
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