Intravenous NPA for the treatment of infarcting myocardium early: InTIME-II, a double-blind comparison on of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction

The InTIME-II Investigators

Research output: Contribution to journalArticle

170 Citations (Scopus)

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. (C) 2000 The European Society of Cardiology.

Original languageEnglish (US)
Pages (from-to)2005-2013
Number of pages9
JournalEuropean Heart Journal
Volume21
Issue number24
DOIs
StatePublished - Jan 1 2000
Externally publishedYes

Fingerprint

Tissue Plasminogen Activator
Myocardium
Myocardial Infarction
Fibrinolytic Agents
Therapeutics
Stroke
Hospital Administration
SUN 9216
Hospital Emergency Service
Safety
Weights and Measures
Survival
Mortality

Keywords

  • Acute myocardial infarction
  • Bolus lytic therapy
  • Lanoteplase

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{0dd03778264941df8419558cf61aa0bc,
title = "Intravenous NPA for the treatment of infarcting myocardium early: InTIME-II, a double-blind comparison on of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction",
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. (C) 2000 The European Society of Cardiology.",
keywords = "Acute myocardial infarction, Bolus lytic therapy, Lanoteplase",
author = "{The InTIME-II Investigators} and E. Braunwald and Neuhaus, {K. L.} and E. Antman and P. Chew and A. Skene and R. Wilcox and E. Ambrosioni and J. Anderson and E. Apetrei and I. Bata and M. Carrageta and J. Col and A. Dalby and R. Davies and J. Deckers and D. Eichman and P. Grande and R. Greene and E. Gurfinkel and J. Heikkil{\"a} and T. Henry and D. Hillis and J. Hochman and K. Huber and J. Kostis and P. Klinke and J. L{\'o}pez-Send{\'o}n and G. McKendall and B. M{\'o}ller and P. Moore and A. Morris and H. Mueller and E. {\"O}st{\"o}r and A. Oto and M. Ruda and Z. Sadowski and M. Schweiger and R. Sequeira and P. Shah and R. Shannon and B. Smith and B. Sobel and R. Steingart and U. Tebbe and J. Toman and M. Traboulsi and A. Vahanian and Warnica, {J. W.} and J. Willerson and Monrad, {E. Scott}",
year = "2000",
month = "1",
day = "1",
doi = "10.1053/euhj.2000.2498",
language = "English (US)",
volume = "21",
pages = "2005--2013",
journal = "European Heart Journal",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "24",

}

TY - JOUR

T1 - Intravenous NPA for the treatment of infarcting myocardium early

T2 - InTIME-II, a double-blind comparison on of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction

AU - The InTIME-II Investigators

AU - Braunwald, E.

AU - Neuhaus, K. L.

AU - Antman, E.

AU - Chew, P.

AU - Skene, A.

AU - Wilcox, R.

AU - Ambrosioni, E.

AU - Anderson, J.

AU - Apetrei, E.

AU - Bata, I.

AU - Carrageta, M.

AU - Col, J.

AU - Dalby, A.

AU - Davies, R.

AU - Deckers, J.

AU - Eichman, D.

AU - Grande, P.

AU - Greene, R.

AU - Gurfinkel, E.

AU - Heikkilä, J.

AU - Henry, T.

AU - Hillis, D.

AU - Hochman, J.

AU - Huber, K.

AU - Kostis, J.

AU - Klinke, P.

AU - López-Sendón, J.

AU - McKendall, G.

AU - Móller, B.

AU - Moore, P.

AU - Morris, A.

AU - Mueller, H.

AU - Östör, E.

AU - Oto, A.

AU - Ruda, M.

AU - Sadowski, Z.

AU - Schweiger, M.

AU - Sequeira, R.

AU - Shah, P.

AU - Shannon, R.

AU - Smith, B.

AU - Sobel, B.

AU - Steingart, R.

AU - Tebbe, U.

AU - Toman, J.

AU - Traboulsi, M.

AU - Vahanian, A.

AU - Warnica, J. W.

AU - Willerson, J.

AU - Monrad, E. Scott

PY - 2000/1/1

Y1 - 2000/1/1

N2 - 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. (C) 2000 The European Society of Cardiology.

AB - 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. (C) 2000 The European Society of Cardiology.

KW - Acute myocardial infarction

KW - Bolus lytic therapy

KW - Lanoteplase

UR - http://www.scopus.com/inward/record.url?scp=0034543078&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034543078&partnerID=8YFLogxK

U2 - 10.1053/euhj.2000.2498

DO - 10.1053/euhj.2000.2498

M3 - Article

C2 - 11102251

AN - SCOPUS:0034543078

VL - 21

SP - 2005

EP - 2013

JO - European Heart Journal

JF - European Heart Journal

SN - 0195-668X

IS - 24

ER -