| Author/Editor | Braunwald, E; Drinovec, I; Horvat, M; Krivec, B; Markež, J; Parežnik, R; Pehnec, Z; Resman, J; Šifrer, F; Skale, R; Trinkaus, D; Voga, G | |
| Title | Intravenous NPA for the treatment of infarcting myocardium early: in TIME-II, a double-blind comparison of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction | |
| Type | članek | |
| Source | Eur Heart J | |
| Vol. and No. | Letnik 21, št. 24 | |
| Publication year | 2000 | |
| Volume | str. 2005-13 | |
| Language | eng | |
| Abstract | Aims: To compare the efficacy and safety of lanoteplase, a single-bolus thrombolytic drug derived from alteplase tissue plasminogen activator, with the established accelerated alteplase regimen in patients presenting within 6 h of onset of ST elevation acute myocardial infarction. Methods and results: 15,078 patients were recruited from 855 hospitals worldwide and randomized in a 2:1 ratio to receive either lanoteplase 120 KU. kg(-1)as a single intravenous bolus, or up to 100 mg accelerated alteplase given over 90 min. The primary end-point was all-cause mortality at 30 days and the hypothesis was that the two treatments would be equivalent. By 30 days, 6.61% of alteplase-treated patients and 6.75% lanoteplase-treated patients had died (relative risk 1.02). Total stroke occurred in 1.53% alteplase- and 1.87% lanoteplase-treated patients (ns); haemorrhagic stroke rates were 0.64% alteplase and 1.12% lanoteplase (P=0.004). The net clinical deficit of 30-day death or non-fatal disabling stroke was 7.0% and 7.2%, respectively. By 6 months, 8.8% of alteplase-treated patients and 8.7% of lanoteplase-treated patients had died. Conclusion: Single-bolus weight-adjusted lanoteplase is an effective thrombolytic agent, equivalent to alteplase in terms of its impact on survival and with a comparable risk-benefit profile. The single-bolus regimen should shorten symptoms to treatment times and be especially convenient for emergency department or out-of-hospital administration. Copyright 2000 The European Society of Cardiology. | |
| Descriptors | MYOCARDIAL INFARCTION FIBRINOLYTIC AGENTS MIDDLE AGE AGED CEREBROVASCULAR DISORDERS DOUBLE-BLIND METHOD INFUSIONS, INTRAVENOUS CEREBRAL HEMORRHAGE RISK FACTORS SURVIVAL ANALYSIS |