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Risk of intracranial haemorrhage with combined fibrinolytic and glycoprotein IIb/IIIa inhibitor therapy in acute myocardial infarction. Dichotomous response as a function of age in the GUSTO V trial.

Publication ,  Journal Article
Savonitto, S; Armstrong, PW; Lincoff, AM; Jia, G; Sila, CA; Booth, J; Terrosu, P; Cavallini, C; White, HD; Ardissino, D; Califf, RM; Topol, EJ
Published in: Eur Heart J
October 2003

BACKGROUND: Intracranial haemorrhage is an important limitation to pharmacologic reperfusion therapy for acute myocardial infarction. The combination of a glycoprotein IIb/IIIa inhibitor, half-dose plasminogen activator and reduced-dose heparin has been evaluated as an alternative to standard fibrinolytic therapy in this setting. METHODS AND RESULTS: We evaluated the relation between univariate and multivariate predictors of intracranial haemorrhage and the effect of treatment with either reteplase alone (10 U bolus twice, 30 min apart) with standard-dose heparin (5000 U bolus followed by an infusion of 1000 Uh(-1)for patients > or =80 kg and 800 Uh(-1)for those <80 kg) or combination therapy with abciximab (0.25mg/kg bolus and 0.125 microg/kg/min for 12h) and half-dose reteplase (two boluses of 5U 30 min apart) with reduced-dose heparin (60 Ukg(-1)bolus, maximum 5000 U, followed by an infusion of 7 Ukg(-1)h(-1)) in the 16 588 patients randomized in the GUSTO V trial. Overall, the incidence of intracranial haemorrhage was similar in the two groups (0.6% vs 0.6%; OR 1.05, 95% CI 0.71, 1.56). The median (25th-75th) time from drug administration to intracranial haemorrhage was 5.5 (3.4-11) hours with combination therapy and 9.2 (5.9-22) hours with reteplase (P=0.048). Among the multivariable predictors of intracranial haemorrhage, only age showed a significant interaction with treatment effect (age per treatment interaction chi-square 4.60, P=0.032) with a lower risk of combination therapy for younger patients and a higher risk for the elderly. CONCLUSIONS: Although no additional risk of intracranial haemorrhage has been observed with combination therapy in the whole population, a significant age pertreatment interaction exists, with a lower risk with combination therapy in younger patients, and a higher risk in the elderly.

Duke Scholars

Published In

Eur Heart J

DOI

ISSN

0195-668X

Publication Date

October 2003

Volume

24

Issue

20

Start / End Page

1807 / 1814

Location

England

Related Subject Headings

  • Tissue Plasminogen Activator
  • Risk Factors
  • Recombinant Proteins
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Male
  • Intracranial Hemorrhages
  • Immunoglobulin Fab Fragments
  • Humans
  • Heparin
 

Citation

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Savonitto, S., Armstrong, P. W., Lincoff, A. M., Jia, G., Sila, C. A., Booth, J., … Topol, E. J. (2003). Risk of intracranial haemorrhage with combined fibrinolytic and glycoprotein IIb/IIIa inhibitor therapy in acute myocardial infarction. Dichotomous response as a function of age in the GUSTO V trial. Eur Heart J, 24(20), 1807–1814. https://doi.org/10.1016/j.ehj.2003.07.004
Savonitto, S., P. W. Armstrong, A. M. Lincoff, G. Jia, C. A. Sila, J. Booth, P. Terrosu, et al. “Risk of intracranial haemorrhage with combined fibrinolytic and glycoprotein IIb/IIIa inhibitor therapy in acute myocardial infarction. Dichotomous response as a function of age in the GUSTO V trial.Eur Heart J 24, no. 20 (October 2003): 1807–14. https://doi.org/10.1016/j.ehj.2003.07.004.
Savonitto S, Armstrong PW, Lincoff AM, Jia G, Sila CA, Booth J, Terrosu P, Cavallini C, White HD, Ardissino D, Califf RM, Topol EJ. Risk of intracranial haemorrhage with combined fibrinolytic and glycoprotein IIb/IIIa inhibitor therapy in acute myocardial infarction. Dichotomous response as a function of age in the GUSTO V trial. Eur Heart J. 2003 Oct;24(20):1807–1814.
Journal cover image

Published In

Eur Heart J

DOI

ISSN

0195-668X

Publication Date

October 2003

Volume

24

Issue

20

Start / End Page

1807 / 1814

Location

England

Related Subject Headings

  • Tissue Plasminogen Activator
  • Risk Factors
  • Recombinant Proteins
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Male
  • Intracranial Hemorrhages
  • Immunoglobulin Fab Fragments
  • Humans
  • Heparin