Key result
Alteplase lowers 2-hour total pulmonary resistance ~18 percentage points more than urokinase.
Why the study?
The comparative effects of intravenous urokinase and alteplase on early resolution of total pulmonary resistance and angiographic severity in acute massive pulmonary embolism needed direct evaluation.
Does intravenous alteplase over 2 hours improve early total pulmonary resistance compared with intravenous urokinase over 12 hours in patients with acute massive pulmonary embolism?
RCT (n=63)
Double-blind
randomly assigned
Yes
Does intravenous alteplase over 2 hours improve early total pulmonary resistance compared with intravenous urokinase over 12 hours in patients with acute massive pulmonary embolism?
In acute massive pulmonary embolism, a 2-hour infusion of alteplase produces a more rapid hemodynamic improvement over the first 3 to 4 hours than a 12-hour infusion of urokinase, though hemodynamic and angiographic results are similar by 12 to 18 hours.
Alteplase may accelerate early hemodynamic stabilization in massive PE; extends comparative thrombolytic data to the critical first hours.
Twelve centers participated in a double-blind study in which 63 patients with angiographically documented acute massive pulmonary embolism were randomly assigned to treatment with either urokinase (4,400 U/kg as an intravenous bolus infusion, then 4,400 U/kg per h over 12 h; n = 29) or alteplase (10 mg as an intravenous bolus infusion, then 90 mg over 2 h) followed by heparin (n = 34). The primary objective was to compare the resolution of pulmonary embolism as judged by the change in total pulmonary resistance over the initial 2 h. Further objectives were to evaluate the changes in total pulmonary resistance over the next 10 h and the degree of angiographic resolution at 12 to 18 h. At 2 h, total pulmonary resistance decreased by 18 +/- 22% in the urokinase group and by 36 +/- 17% in the alteplase group (p = 0.0009). Continuous monitoring of pulmonary artery mean pressure, cardiac index and total pulmonary resistance revealed that these variables improved faster in the alteplase group, with consistently significant intergroup differences from 30 min up to 3 to 4 h. After 12 h, the decrease in total pulmonary resistance was 53 +/- 19% in the urokinase group compared with 48 +/- 17% in the alteplase group and the reduction in the angiographic severity score was 30 +/- 25% compared with 24 +/- 18%, respectively, with no significant intergroup differences. Bleeding was equally frequent in the two treatment groups, except that more urokinase-treated patients experienced hematomas at puncture sites.
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Meyer et al. (1992) conducted an RCT in Acute massive pulmonary embolism (n=63). Alteplase followed by heparin vs. Urokinase (4,400 U/kg intravenous bolus infusion, then 4,400 U/kg per h over 12 h) was evaluated on Decrease in total pulmonary resistance over the initial 2 hours (p=0.0009). Alteplase achieved a faster 2-hour reduction in total pulmonary resistance than urokinase (36% vs 18%, p=0.0009), though 12-hour differences were not significant.
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