July 22, 2018
Results Published From OPTALYSE PE Trial of BTG's Ekos System
July 23, 2018—BTG International announced the publication of the OPTALYSE PE trial results by Victor F. Tapson, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions (2018:11;1401–1410). The findings were presented at the Society for Cardiovascular Angiography and Interventions scientific sessions, held April 25–28 in San Diego, California.
According to BTG, the published findings further confirm that bilateral pulmonary embolisms (PEs) treated in as little as 2 hours with the company's endovascular Ekos acoustic pulse thrombolysis therapy show a significant improvement in right ventricular/left ventricular (RV/LV) ratio and a very low 1-year mortality rate of 2% and an equally low 1-year recurrent PE rate of 2%. These results were achieved with considerably less tissue plasminogen activator (tPA; total, as low as 8 mg) than used in previous studies, noted the company.
Dr. Tapson, who is from the Pulmonary and Critical Care Division at Cedars-Sinai Medical Center in Los Angeles, California, commented in the company's announcement, “The publication of OPTALYSE PE further solidifies these findings as a potential new standard for PE treatment. The body of clinical evidence, including the ULTIMA and SEATTLE II studies, reveals an opportunity to advance PE patient care with more flexible and efficient deployment of intensive care, drug, and clinician time, along with enhanced safety and speed.”
BTG stated that the OPTALYSE PE study was composed of 101 patients with acute proximal PE at 17 centers randomized to one of four cohorts of Ekos therapy. The first cohort received 4 mg tPA per device over 2 hours, the second cohort received 4 mg tPA per device over 4 hours, the third cohort received 6 mg tPA per device over 6 hours, and the fourth cohort received 12 mg tPA per device for 6 hours.
All four cohorts demonstrated significant reduction in RV/LV diameter ratio (approximately 23%–26%). This is consistent with previous studies where treatment took place from 12 to 24 hours.
Additionally, the OPTALYSE PE results included a very low bleeding rate of 3% compared to 10% in the SEATTLE II study, in which patients received treatment with 24-mg tPA for 12 or 24 hours. One-year data from OPTALYSE PE demonstrated an increase in quality of life of more than 30%.
A separate registry study underway, KNOCOUT PE, is intended to measure how institutions are adopting OPTALYSE PE and this new standard of care. The study is expected to include as many as 100 centers globally and is currently enrolling, advised BTG.