Date: 2013-03-11
Type of information:
phase:
Announcement: presentation of data at the American College of Cardiology 62nd Annual Scientific Sessions and Expo
Company: Boehringer Ingelheim (Germany)
Product: Metalyse® (tenecteplase, TNK-tPA)
Action mechanism: Metalyse® (tenecteplase, TNK-tPA) is a fibrin clot dissolving drug indicated for the thrombolytic treatment of acute myocardial infarction.
Disease: myocardial infarction
Therapeutic area: Cardiovascular diseases
Country: Austria, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Italy, Norway, Peru, Poland, Russian Federation, Serbia, Spain, UK
Trial
details: STREAM (STrategic Reperfusion Early After Myocardial Infarction) is an open-label, prospective, randomized, parallel, comparative, international, multicenter exploratory trial to evaluate the outcome of prehospital patients presenting with a large ST-elevation myocardial infarction within 3 hours of symptom onset.
Almost 2000 patients were randomized to fibrinolysis with Metalyse® combined with enoxaparin, clopidogrel, and aspirin, and followed by timely cardiac catheterization within 6 to 24 hours, or rescue coronary intervention if reperfusion fails within 90 minutes of fibrinolysis, versus PCI performed according to local standards. Composite efficacy primary end point at 30 days included death, shock, heart failure, and reinfarction. Safety end points include ischemic stroke, intracranial hemorrhage, and major nonintracranial bleeding. Follow-up is extended to 1 year and includes all-cause mortality. STREAM excluded STEMI patients able to undergo primary PCI within 60 minutes of first medical contact. (NCT00623623)
Latest
news: * On March 10, 2013, Boehringer Ingelheim has presented new data at the American College of Cardiology 62nd Annual Scientific Sessions and Expo. These data 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. 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.
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).
