Pharmaco-invasive strategy including Metalyse® delivers comparable clinical outcomes to primary PCI for STEMI patients who could not undergo primary PCI within one hour from first medical contact

New data support prehospital or early fibrinolysis with Metalyse® followed by angiography within 6-24 hours in patients presenting early with STEMI, who do not have access to primary PCI within the recommended time-frame of 60 minutes from first medical contact

INGELHEIM, Germany - Monday, March 11th 2013 [ME NewsWire]

(BUSINESS WIRE)-- For NON-U.S. Media Only

New data presented at the American College of Cardiology 62nd Annual Scientific Sessions and Expo demonstrate that patients with ST elevation acute myocardial infarction (STEMI), who cannot undergo primary percutaneous intervention (PCI) in a catheterization lab within 60 minutes of first medical contact, have similar clinical outcomes from early fibrinolysis with Metalyse® (tenecteplase, TNK-tPA) followed by timely angiography (pharmaco-invasive strategy), compared to primary PCI.1

“A significant number of patients who suffer from an acute heart attack don’t reach a cath lab within the recommended timeframe” said STREAM Principal Investigator Professor F. Van de Werf, University Hospital Gasthuisberg, Leuven, Belgium. “Prehospital fibrinolysis with timely coronary angiography, although associated with a small risk of intracranial bleeding, resulted in effective reperfusion in early presenting STEMI patients who cannot undergo primary PCI within one hour of first medical contact.”

The STREAM (STrategic Reperfusion Early After Myocardial Infarction) study is the first randomized, prospective exploratory study of a pharmaco-invasive strategy for patients with STEMI. The study evaluated the outcome of patients randomized to fibrinolysis with Metalyse®, within 3 hours of symptom onset and followed by timely angiography within 6 to 24 hours, versus primary PCI performed according to local standards.1

The primary composite endpoint of death, cardiogenic shock, congestive heart failure and reinfarction within 30 days was observed in 12.4% of patients who received Metalyse® within the pharmaco-invasive strategy including angiography within 6-24 hours, compared to 14.3% of patients who received early primary PCI (relative risk 0.86 (0.68-1.09)).1

The study results revealed no significant treatment interactions. Cardiogenic shock (4.4% vs 5.9% p=0.13) and congestive heart failure (6.1% vs 7.6% p=0.18) occurred less frequently in the pharmaco-invasive patients. For the other single clinical endpoints, namely all cause mortality (4.6 % vs 4.4% p=0.88) and reinfarction (2.5% vs 2.2% p=0.74), the rates for pharmaco-invasive arm and primary PCI respectively, were similar.2

The stroke rates (all types) were modest but strokes were significantly more frequent in the pharmaco-invasive arm (1.6% vs 0.5% p=0.03). There was no significant difference in the number of non-intracranial bleedings (6.5% in pharmaco-invasive arm vs 4.8% in PPCI, p=0.11).2

“The results from STREAM confirm that patients who receive fibrinolytic treatment, followed by angiography within 24 hours, have a similar 30 day outcome to those receiving early primary PCI” said Co-principal Investigator of STREAM, Professor A. Gershlick, University of Leicester. “These results provide a potential therapeutic option for emergency physicians and cardiologists in those patients who cannot receive primary PCI within the guideline mandated times. Despite continued global efforts to decrease time from first medical contact to primary PCI, time delays may still be present in geographically challenging areas and the pharmaco-invasive strategy should be considered in such scenarios.”

Providing early PCI can be a major operational challenge.2 Globally, PCI is not always easily or equally attainable for STEMI patients3 and a significant proportion of patients worldwide do not achieve guideline-mandated times for primary PCI.4,5

“The results of STREAM are particularly significant for patients in countries where there is a shortage of PCI facilities, as well as in areas where factors such as heavy traffic can impact the prospect of patients successfully receiving early primary PCI.” explained Dr. P. Goldstein, Emergency Physician, Lille, France. “This is an important study in the field of acute cardiac care and has confirmed that prehospital initial fibrinolysis can play a significant role in broadening the therapeutic time window for angiography to up to 24 hours in patients who cannot reach a cath lab within 60 minutes.”

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Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/11_march_2013_tenecteplase.html

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