Spaulding, C. and Henry, P. and Teiger, E. and Beatt, K. and Bramucci, E. and Merkely, Béla Péter (2006) Sirolimus-eluting versus uncoated stents in acute myocardial infarction. NEW ENGLAND JOURNAL OF MEDICINE, 355 (11). pp. 1093-1104. ISSN 0028-4793
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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].).
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| Additional Information: | Study Group - TYPHOON Investigators The following investigators and institutions participated in the TYPHOON study: Steering Committee: C. Spaulding, C. Bode, E. Bramucci, P. Henry, E. Teiger, D. Carrie, M. Slama, K. Beatt; Sponsor: Cordis, Warren, NJ — D. Donohoe (medical director), D. Snead, R. Dalal, S. Sun; Cordis, Waterloo, Belgium — H.-P. Stoll (program director), A. Cebrian (program coordination), L. Wheeler; Data and Safety Monitoring Board: B. Meier, Switzerland; B. Lancelin, France; J.-F. Neumann, Germany; Clinical Events Committee: A. Caspi (chair), Israel; G. Maurer, Austria; S. Cook, Switzerland; Data Management and Monitoring: Hesperion, Clinical Development Services, Allschwil, Switzerland — V. Charlon (director); C. Berge; P. Rush; Electronic Data Capture: PPD GlobalView Web Services, New Hope, MN; Core Angiographic Laboratory: Bio Imaging Technologies, Leiden, the Netherlands — A. Van Weert (director); Clinical Sites: Royal Perth Hospital, Perth, Australia — R. Clugston, M. Bonner; Hôpital Cantonal de Genève, Geneva — E. Camenzind, N. Masson; Nemocnice Ceske, Budejovice, Czech Republic — L. Pesl; Poruba School of Medicine, Poruba, Czech Republic — R. Stipal, L. Pleva; Medizinische Universitätsklinik Freiburg, Freiburg, Germany — C. Bode, M. Zehender, S. Richter; Universitätskliniken des Saarlandes, Homburg Saar, Germany — G. Nickenig, N. Werner; Medizinische Klinik und Poliklinik Johannes-Gutenberg-Universität, Mainz, Germany — F. Post; Københavns Amtssygehus Gentofte, Hellerup, Denmark — U. Abildgaard, A. Galloe; Virgen de la Arrixaca, Murcia, Spain — M. Valdés, E. Pinar; Hôpital Européen Georges Pompidou, Paris — N. Danchin; Institut Mutualiste Montsouris, Paris — A. Dibie, F. Larrazet, F. Philippe; Clinique du Millénaire, Montpellier, France — X. De Boisgelin, G. Levy; Hôpital Lariboisiere, Paris — P. Henry, G. Sideris, R. Fressonnet; Hôpital Bichat, Paris — J.-M. Juliard, P. Aubry; Hôpital Tenon, Paris — P. Michel, E. Garbarz; Hôpital Béclère, Clamart, France — M. Slama, P. Colin; Hôpital Cochin, Paris — C. Spaulding, O. Varenne; Henri Mondor Hospital, Paris — E. Teiger, J. Dubois-Randé, S. Champagne; Centre Hospitalier Universitaire Toulouse–Hôpital Rangueil, Toulouse, France — D. Carrié, J. Roncalli, J. Cahuzac; Clinique Les Fleurs, Marseille, France — P. Commeau, P. Barragan; Hôpital Guillaume et René Laennec, Centre Hospitalier Universitaire Nord, St. Herblain, France — P. Guerin, A. Tirouvanziam; Clinique St. Augustin, Bordeaux, France — O. Darremont, J. Leymarie; Centre Hospitalier Régional d'Orleans–Hôpital de la Source, Orleans, France — O. Dibon; Clinique Pasteur, Toulouse, France — J. Fajadet, B. Farah, B. Assoun; Centre Cardiologique du Nord, Saint Denis, France — P. Guyon, B. Chevalier; Clinique Victor Pauchet, Amiens, France — A. Py, E. Dadez; Centre Hospitalier Universitaire de Rennes, Rennes, France — H. Le Breton, M. Bedossa; Centre Hospitalier Universitaire Mulhouse, Mulhouse, France — L. Jacquemin, R. ElBelghit; Institut Hospitalier Jacques Cartier, Massy, France — M. Morice, T. Lefèvre; Centre Hospitalier Universitaire Avignon, Avignon, France — M. Pansieri, M. Metge; Clinique de la Casamance, Aubagne, France — B. Valeix; Clinique Médico-Chirurgicale Les Fontaines, Melun, France — P. Dupouy, E. Aptecar; Cardiovascular Center, Semmelweis University, Budapest, Hungary — B. Merkely, G. Szabó; Wolfson Medical Center, Holon, Israel — Y. Rozenman, V. Witzling; Assaf Harofeh Medical Center, Zrifin, Israel — R. Krakover, I. Zyssman; Soroka Medical Center, Beer Sheva, Israel — R. Ilia, C. Cafri; Souraski Medical Center, Tel Aviv, Israel — H. Miller, A. Finkelstein; Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy — E. Bramucci, M. Ferlini, U. Canosi; San Filippo Neri Hospital, Rome — G. Richichi, V. Pasceri; Azienda Ospedale Luigi Sacco, Milan — P. Viecca; Azienda Ospedaliera Careggi, Florence, Italy — M. Margheri, C. Giglioli; Pauls Stradins University Hospital, Riga, Latvia — A. Erglis; I. Narbute; University Medical Center Utrecht, Utrecht, the Netherlands — P. Stella; P. Elsman; Slaskie Centrum Chorób Serca, Zabrze, Poland — L. Poloski; Hospital Fernando Fonseca, Amadora, Portugal — P. Farto e Abreu; Hospital Garcia Orta, Almada, Portugal — H. Pereira; Hammersmith Hospital, London — K. Beatt; and Southampton General Hospital, Southampton, United Kingdom — K. Dawkins. |
| Subjects: | R Medicine / orvostudomány > RC Internal medicine / belgyógyászat |
| SWORD Depositor: | MTMT SWORD |
| Depositing User: | MTMT SWORD |
| Date Deposited: | 25 Jul 2014 09:48 |
| Last Modified: | 25 Jul 2014 09:48 |
| URI: | http://real.mtak.hu/id/eprint/13934 |
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