Recombinant tissue-type plasminogen activator versus a novel dosing regimen of urokinase in acute pulmonary embolism: a randomized controlled multicenter trial

Samuel Z. Goldhaber, Craig M. Kessler, John A. Heit, C. Gregory Elliott, William R. Friedenberg, Darell E. Heiselman, David B. Wilson, John Anthony Parker, Don Bennett, Michael L. Feldstein, Andrew P. Selwyn, Ducksoo Kim, G. V R K Sharma, James S. Nagel, Michael F. Meyerovitz

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Abstract

Thrombolysis of acute pulmonary embolism can be accomplished more rapidly and safely with 100 mg of recombinant human tissue-type plasminogen activator (rt-PA) (Activase) than with a conventional dose of urokinase (Abbokinase) given as a 4,400-U/kg bolus dose, followed by 4,400 U/kg per h for 24 h. To determine the effects of a more concentrated urokinase dose administered over a shorter time course, this trial enrolled 90 patients with baseline perfusion lung scans and angiographically documented pulmonary embolism. They were randomized to receive either 100 mg/2 h of rt-PA or a novel dosing regimen of urokinase: 3 million U/2 h with the initial 1 million U given as a bolus injection over 10 min. Both drugs were delivered through a peripheral vein. To assess efficacy after initiation of therapy, repeat pulmonary angiograms at 2 h were performed in 87 patients and then graded in a blinded manner by a panel of six investigators. Of the 42 patients allocated to rt-PA therapy, 79% showed angiographic improvement at 2 h, compared with 67% of the 45 patients randomized to urokinase therapy (95% confidence interval for the difference in these proportions [rt-PA minus urokinase] is -6.6% to 30.4%; p = 0.11). The mean change in perfusion lung scans between baseline and 24 h was similar for both treatments. Three patients (two treated with rt-PA and one with urokinase) had an intracranial hemorrhage, which was fatal in one. The results indicate that a 2-h regimen of rt-PA and a new dosing regimen of urokinase exhibit similar efficacy and safety for treatment of acute pulmonary embolism.

Original languageEnglish (US)
Pages (from-to)24-30
Number of pages7
JournalJournal of the American College of Cardiology
Volume20
Issue number1
DOIs
StatePublished - 1992

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Urokinase-Type Plasminogen Activator
Tissue Plasminogen Activator
Pulmonary Embolism
Multicenter Studies
Randomized Controlled Trials
Lung
Perfusion
Intracranial Hemorrhages
Therapeutics
Veins
Angiography
Research Personnel
Confidence Intervals
Safety
Injections
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Nursing(all)

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Recombinant tissue-type plasminogen activator versus a novel dosing regimen of urokinase in acute pulmonary embolism : a randomized controlled multicenter trial. / Goldhaber, Samuel Z.; Kessler, Craig M.; Heit, John A.; Elliott, C. Gregory; Friedenberg, William R.; Heiselman, Darell E.; Wilson, David B.; Parker, John Anthony; Bennett, Don; Feldstein, Michael L.; Selwyn, Andrew P.; Kim, Ducksoo; Sharma, G. V R K; Nagel, James S.; Meyerovitz, Michael F.

In: Journal of the American College of Cardiology, Vol. 20, No. 1, 1992, p. 24-30.

Research output: Contribution to journalArticle

Goldhaber, SZ, Kessler, CM, Heit, JA, Elliott, CG, Friedenberg, WR, Heiselman, DE, Wilson, DB, Parker, JA, Bennett, D, Feldstein, ML, Selwyn, AP, Kim, D, Sharma, GVRK, Nagel, JS & Meyerovitz, MF 1992, 'Recombinant tissue-type plasminogen activator versus a novel dosing regimen of urokinase in acute pulmonary embolism: a randomized controlled multicenter trial', Journal of the American College of Cardiology, vol. 20, no. 1, pp. 24-30. https://doi.org/10.1016/0735-1097(92)90132-7
Goldhaber, Samuel Z. ; Kessler, Craig M. ; Heit, John A. ; Elliott, C. Gregory ; Friedenberg, William R. ; Heiselman, Darell E. ; Wilson, David B. ; Parker, John Anthony ; Bennett, Don ; Feldstein, Michael L. ; Selwyn, Andrew P. ; Kim, Ducksoo ; Sharma, G. V R K ; Nagel, James S. ; Meyerovitz, Michael F. / Recombinant tissue-type plasminogen activator versus a novel dosing regimen of urokinase in acute pulmonary embolism : a randomized controlled multicenter trial. In: Journal of the American College of Cardiology. 1992 ; Vol. 20, No. 1. pp. 24-30.
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abstract = "Thrombolysis of acute pulmonary embolism can be accomplished more rapidly and safely with 100 mg of recombinant human tissue-type plasminogen activator (rt-PA) (Activase) than with a conventional dose of urokinase (Abbokinase) given as a 4,400-U/kg bolus dose, followed by 4,400 U/kg per h for 24 h. To determine the effects of a more concentrated urokinase dose administered over a shorter time course, this trial enrolled 90 patients with baseline perfusion lung scans and angiographically documented pulmonary embolism. They were randomized to receive either 100 mg/2 h of rt-PA or a novel dosing regimen of urokinase: 3 million U/2 h with the initial 1 million U given as a bolus injection over 10 min. Both drugs were delivered through a peripheral vein. To assess efficacy after initiation of therapy, repeat pulmonary angiograms at 2 h were performed in 87 patients and then graded in a blinded manner by a panel of six investigators. Of the 42 patients allocated to rt-PA therapy, 79{\%} showed angiographic improvement at 2 h, compared with 67{\%} of the 45 patients randomized to urokinase therapy (95{\%} confidence interval for the difference in these proportions [rt-PA minus urokinase] is -6.6{\%} to 30.4{\%}; p = 0.11). The mean change in perfusion lung scans between baseline and 24 h was similar for both treatments. Three patients (two treated with rt-PA and one with urokinase) had an intracranial hemorrhage, which was fatal in one. The results indicate that a 2-h regimen of rt-PA and a new dosing regimen of urokinase exhibit similar efficacy and safety for treatment of acute pulmonary embolism.",
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