Literature DB >> 23473396

Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.

Paul W Armstrong1, Anthony H Gershlick, Patrick Goldstein, Robert Wilcox, Thierry Danays, Yves Lambert, Vitaly Sulimov, Fernando Rosell Ortiz, Miodrag Ostojic, Robert C Welsh, Antonio C Carvalho, John Nanas, Hans-Richard Arntz, Sigrun Halvorsen, Kurt Huber, Stefan Grajek, Claudio Fresco, Erich Bluhmki, Anne Regelin, Katleen Vandenberghe, Kris Bogaerts, Frans Van de Werf.   

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.).

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Year:  2013        PMID: 23473396     DOI: 10.1056/NEJMoa1301092

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   176.079


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