Victor F Tapson1, Keith Sterling2, Noah Jones3, Mahir Elder4, Uttam Tripathy5, Jayson Brower6, Robert L Maholic7, Charles B Ross8, Kannan Natarajan9, Pete Fong10, Lee Greenspon11, Houman Tamaddon12, Amir R Piracha13, Tod Engelhardt14, John Katopodis15, Vasco Marques16, Andrew S P Sharp17, Gregory Piazza18, Samuel Z Goldhaber18. 1. Pulmonary/Critical Care Division, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: victor.tapson@cshs.org. 2. Cardiovascular & Interventional Radiology, Inova Alexandria Hospital, Alexandria, Virginia. 3. Mount Carmel Health System, Columbus, Ohio. 4. Detroit Medical Center/Wayne State University School of Medicine, Detroit, Michigan. 5. Houston Methodist Sugarland Hospital, Sugarland, Texas. 6. Providence Sacred Heart Medical Center, Spokane, Washington. 7. UPMC-Hamot Heart and Vascular Institute, Erie, Pennsylvania. 8. Piedmont Atlanta Hospital, Piedmont Heart, Atlanta, Georgia. 9. St. Vincent Hospital and Health Care Center, Indianapolis, Indiana. 10. Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, Tennessee. 11. Pulmonary Critical Care Division, Lankenau Medical Center, Wynnewood, Pennsylvania. 12. University Hospital, Augusta, Georgia. 13. Jewish Hospital, Kentucky One Health Cardiology Associates, Louisville, Kentucky. 14. East Jefferson General Hospital, Metairie, Louisiana. 15. Tallahassee Memorial Hospital, Tallahassee, Florida. 16. Florida Hospital, Tampa, Florida. 17. Royal Devon & Exeter NHS Foundation Trust and University of Exeter, Exeter, United Kingdom. 18. Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Abstract
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 bycomputed 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.
RCT Entities:
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.
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