Two trials of reduced bolus alteplase in the treatment of pulmonary embolism. An overview.
The Bolus Alteplase Pulmonary Embolism (BAPE) Group and a consortium of French investigators utilized essentially the same investigational protocol to test reduced dose bolus alteplase vs full dose 100 mg/2 h alteplase in the treatment of pulmonary embolism (PE). The principal hypothesis was that reduced dose bolus alteplase (n = 96) would result in fewer bleeding complications than full dose 100 mg of 2 h alteplase (n = 44) administered as a continuous infusion to hemodynamically stable patients with PE. To provide data on bolus alteplase's safety profile in a larger sample size than would have been feasible in either trial alone, we present an overview of the BAPE and French trials. There were no differences between the reduced dose bolus and full dose 2 h rt-PA groups with respect to bleeding complications. Therefore, the principal hypothesis of these two randomized controlled trials could not be confirmed. Efficacy was similar in the two treatment groups. Interpretation of the results will vary because the increased convenience and cost savings from using a reduced dose of bolus alteplase may be offset by a higher mortality rate. However, a trial that compared the mortality rates of the two treatment regimens would have required more than 800 patients.
Goldhaber
S Z
SZ
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston 02115.
Feldstein
M L
ML
Sors
H
H
D006801:Humans; D011655:Pulmonary Embolism / Q000150:complications / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects
D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator