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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/15183

Title: Fibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction
Authors: Armstrong, Paul W.
Gershlick, Anthony H.
Goldstein, Patrick
Wilcox, Robert
Danays, Thierry
Lambert, Yves
Sulimov, Vitaly
Rosell Ortiz, Fernando
Ostojic, Miodrag
Welsh, Robert C.
Carvalho, Antonio C.
Nanas, John
Arntz, Hans-Richard
Halvorsen, Sigrun
Huber, Kurt
Grajek, Stefan
Fresco, Claudio
Bluhmki, Erich
Regelin, Anne
Vandenberghe, Katleen
BOGAERTS, Kris
Van de Werf, Frans
Issue Date: 2013
Publisher: MASSACHUSETTS MEDICAL SOC
Citation: NEW ENGLAND JOURNAL OF MEDICINE, 368 (15), p. 1379-1387
Abstract: BACKGROUND It is not known whether prehospital fibrinolysis, coupled with timely coronary angiography, provides a clinical outcome similar to that with primary percutaneous coronary intervention (PCI) early after acute ST-segment elevation myocardial infarction (STEMI). METHODS Among 1892 patients with STEMI who presented within 3 hours after symptom onset and who were unable to undergo primary PCI within 1 hour, patients were randomly assigned to undergo either primary PCI or fibrinolytic therapy with bolus tenecteplase (amended to half dose in patients >= 75 years of age), clopidogrel, and enoxaparin before transport to a PCI-capable hospital. Emergency coronary angiography was performed if fibrinolysis failed; otherwise, angiography was performed 6 to 24 hours after randomization. The primary end point was a composite of death, shock, congestive heart failure, or reinfarction up to 30 days. RESULTS The primary end point occurred in 116 of 939 patients (12.4%) in the fibrinolysis group and in 135 of 943 patients (14.3%) in the primary PCI group (relative risk in the fibrinolysis group, 0.86; 95% confidence interval, 0.68 to 1.09; P = 0.21). Emergency angiography was required in 36.3% of patients in the fibrinolysis group, whereas the remainder of patients underwent angiography at a median of 17 hours after randomization. More intracranial hemorrhages occurred in the fibrinolysis group than in the primary PCI group (1.0% vs. 0.2%, P = 0.04; after protocol amendment, 0.5% vs. 0.3%, P = 0.45). The rates of nonintracranial bleeding were similar in the two groups. CONCLUSIONS Prehospital fibrinolysis with timely coronary angiography resulted in effective reperfusion in patients with early STEMI who could not undergo primary PCI within 1 hour after the first medical contact. However, fibrinolysis was associated with a slightly increased risk of intracranial bleeding. (Funded by Boehringer Ingelheim; ClinicalTrials.gov number, NCT00623623.)
Notes: Van De Werf, F (reprint author),Katholieke Univ Leuven, Univ Hosp Leuven, Dept Cardiovasc Sci, Herestr 49, B-3000 Louvain, Belgium. Univ Alberta, Canadian Virtual Coordinating Ctr Global Collabor, Edmonton, AB, Canada. Univ Alberta, Mazankowski Alberta Heart Inst, Edmonton, AB, Canada. Univ Hosp Leicester Trust, Leicester Cardiovasc Biomed Res Unit, Natl Inst Hlth Res, Leicester, Leics, England. Univ Nottingham, Dept Cardiovasc Med, Nottingham NG7 2RD, England. Lille Univ Hosp, Emergency Dept, Lille, France. Lille Univ Hosp, SAMU, Lille, France. Boehringer Ingelheim GmbH & Co KG, Reims, France. Ctr Hosp Versailles, SAMU 78, Versailles, France. Mobile Intens Care Unit, Versailles, France. First Moscow State Med Univ, Dept Internal Dis, Moscow, Russia. Empresa Publ Emergencias Sanitarias, Almeria, Spain. Univ Belgrade, Sch Med, Belgrade, Serbia. Univ Fed Sao Paulo, Dept Med, Div Cardiol, Sao Paulo, Brazil. Univ Athens, Dept Cardiol 3, GR-10679 Athens, Greece. Benjamin Franklin Med Ctr, Charite, Berlin, Germany. Univ Oslo, Ulleval Hosp, Dept Cardiol, Oslo, Norway. Wilhelminenhosp, Dept Med Cardiol & Emergency Med 3, Vienna, Austria. Poznan Univ Med Sci, Dept Cardiol, Poznan, Poland. Azienda Osped Univ Udine, Dept Cardiothorac Sci, Udine, Italy. Boehringer Ingelheim GmbH & Co KG, Biberach, Germany. Boehringer Ingelheim GmbH & Co KG, Basel, Switzerland. Katholieke Univ Leuven, Dept Cardiovasc Sci, B-3000 Louvain, Belgium. Katholieke Univ Leuven, Interuniv Inst Biostat & Stat Bioinformat, B-3000 Louvain, Belgium. Univ Hasselt, Hasselt, Belgium. frans.vandewerf@med.kuleuven.be
URI: http://hdl.handle.net/1942/15183
DOI: 10.1056/NEJMoa1301092
ISI #: 000317333600005
ISSN: 0028-4793
Category: A1
Type: Journal Contribution
Validation: ecoom, 2014
Appears in Collections: Research publications

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