A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism
| Autor: | Gregory Piazza, Lee Greenspon, Amir R. Piracha, Kannan Natarajan, Vasco Marques, Robert Maholic, Keith M. Sterling, Samuel Z. Goldhaber, Uttam Tripathy, Andrew S.P. Sharp, John N. Katopodis, Noah Jones, Victor F. Tapson, Mahir Elder, Charles B. Ross, J. Brower, Tod C. Engelhardt, Pete Fong, Houman Tamaddon |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Lung Pulse (signal processing) business.industry medicine.medical_treatment Thrombolysis 030204 cardiovascular system & hematology medicine.disease Tissue plasminogen activator Pulmonary embolism law.invention 03 medical and health sciences 0302 clinical medicine medicine.anatomical_structure Randomized controlled trial law Internal medicine Fibrinolysis medicine Cardiology 030212 general & internal medicine Cardiology and Cardiovascular Medicine business Intermediate risk medicine.drug |
| Zdroj: | JACC: Cardiovascular Interventions. 11:1401-1410 |
| ISSN: | 1936-8798 |
| DOI: | 10.1016/j.jcin.2018.04.008 |
| Popis: | Objectives The aim of this study was to determine the lowest optimal tissue plasminogen activator (tPA) dose and delivery duration using ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk (submassive) pulmonary embolism. Background Previous trials of USCDT used tPA over 12 to 24 h at doses of 20 to 24 mg for acute pulmonary embolism. Methods Hemodynamically stable adults with acute intermediate-risk pulmonary embolism documented by computed tomographic angiography were randomized into this prospective multicenter, parallel-group trial. Patients received treatment with 1 of 4 USCDT regimens. The tPA dose ranged from 4 to 12 mg per lung and infusion duration from 2 to 6 h. The primary efficacy endpoint was reduction in right ventricular–to–left ventricular diameter ratio by computed tomographic angiography. A major secondary endpoint was embolic burden by refined modified Miller score, measured on computed tomographic angiography 48 h after initiation of USCDT. Results One hundred one patients were randomized, and improvements in right ventricular–to–left ventricular diameter ratio were as follows: arm 1 (4 mg/lung/2 h), 0.40 (24%; p = 0.0001); arm 2 (4 mg/lung/4 h), 0.35 (22.6%; p = 0.0001); arm 3 (6 mg/lung/6 h), 0.42 (26.3%; p = 0.0001); and arm 4 (12 mg/lung/6 h), 0.48 (25.5%; p = 0.0001). Improvement in refined modified Miller score was also seen in all groups. Four patients experienced major bleeding (4%). Of 2 intracranial hemorrhage events, 1 was attributed to tPA delivered by USCDT. Conclusions Treatment with USCDT using a shorter delivery duration and lower-dose tPA was associated with improved right ventricular function and reduced clot burden compared with baseline. The major bleeding rate was low, but 1 intracranial hemorrhage event due to tPA delivered by USCDT did occur. |
| Databáze: | OpenAIRE |
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