Why the study?
Recombinant human tissue-type plasminogen activator (rt-PA), a relatively clot-specific fibrinolytic agent, offered a novel and promising approach to thrombolytic therapy of pulmonary embolism whose efficacy and safety required assessment.
Does peripheral intravenous recombinant human tissue-type plasminogen activator (rt-PA) rapidly and safely lyse clots and reduce pulmonary artery pressure in patients with angiographically documented acute pulmonary embolism?
Does peripheral intravenous recombinant human tissue-type plasminogen activator (rt-PA) rapidly and safely lyse clots and reduce pulmonary artery pressure in patients with angiographically documented acute pulmonary embolism?
Peripheral intravenous rt-PA rapidly induced angiographic clot lysis and significantly lowered pulmonary artery pressure within 6 hours in patients with acute pulmonary embolism, with two major bleeding events requiring surgery.
Recombinant human tissue-type plasminogen activator (rt-PA), a relatively clot-specific fibrinolytic agent, represents a novel and promising approach to thrombolytic therapy of pulmonary embolism. Therefore, the efficacy and safety of peripheral intravenous rt-PA therapy were assessed in 47 patients with angiographically documented pulmonary embolism. The drug regimen was 50 mg over 2 hours followed by repeat angiography and, if necessary, an additional 40 mg over 4 hours. By 6 hours, 44 of the 47 patients had angiographic evidence of clot lysis that was slight (n = 5), moderate (n = 12) or marked (n = 27). Among the 34 patients with pulmonary hypertension before treatment (mean pulmonary artery pressure exceeding 17 mm Hg), the pressure decreased from 43/17 (mean 27) to 31/13 (mean 19) mm Hg (p less than 0.0001). Fibrinogen decreased 33% from baseline at 2 hours and 42% from baseline at 6 hours. There were two major complications that required surgical control of bleeding: hemorrhage from a pelvic tumor and mediastinal tamponade in a patient 8 days after coronary artery bypass surgery. The initial results demonstrate that, among selected patients, peripheral intravenous rt-PA can rapidly and, for the most part, safely lyse pulmonary embolism within 6 hours.
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Goldhaber et al. (1987) studied Acute pulmonary embolism (n=47). Recombinant human tissue-type plasminogen activator (rt-PA) was evaluated on Angiographic evidence of clot lysis at 6 hours (p=<0.0001).
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