Long-Term Results Presented From OPTALYSE PE Trial of Ekos Therapy For Pulmonary Embolism
February 6, 2018—BTG plc announced that 1-year results from the OPTALYSE PE trial were presented at ISET, the annual International Symposium on Endovascular Therapy held February 3–7 in Hollywood, Florida.
The trial is evaluating treatment of pulmonary embolism (PE) with the company's Ekos EkoSonic endovascular system—an acoustic pulse thrombolysis therapy—over a shorter period and with lower thrombolytic doses than the current standard. The Ekos system uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs to effectively dissolve clots and restore healthy heart function and blood flow.
According to the company, the findings confirm that patients with bilateral PE treated with Ekos therapy in as little as 2 hours with a total tissue plasminogen activator (tPA) dose as low as 8 mg continue to show improvements in right ventricle-to-left ventricle (RV/LV) ratio over the long term, with an all-cause mortality rate of 2%, a recurrent PE rate of 2%, and continued quality of life (QOL) improvements. These findings demonstrate the efficacy and safety of the OPTALYSE PE treatment regimens, stated BTG.
Victor Tapson, MD, the study's Principal Investigator, commented in the company's announcement, "The long-term follow-up results reinforce that a new interventional standard is being set for PE treatment. The 2% 1-year all-cause mortality rate observed in OPTALYSE PE is much lower than the approximately 8% rate seen in comparable anticoagulation studies. This is important for institutions that are adopting the new low-dose, shorter duration treatments explored in OPTALYSE PE." Dr. Tapson is Director, Venous Thromboembolism and Pulmonary Vascular Disease Research Program at Cedars-Sinai Medical Center in Los Angeles, California.
As summarized by BTG, the investigators followed the 12-month outcomes of 101 patients at 17 centers who participated in the OPTALYSE PE study in which patients were randomized one of four cohorts. These patients were diagnosed with acute proximal PE in at least one main or proximal lobar pulmonary artery and had an RV/LV diameter ratio ≥ 0.9 on chest CTA. Patients received treatment within 48 hours of diagnosis. The four cohorts ranged from 2 to 6 hours in treatment duration and 8 to 24 mg total tPA for bilateral PE.
All cohorts showed a significant reduction in RV/LV by approximately 23% to 26% as measured by CTA at 48 hours. For follow-up, patients received echocardiograms at 4 hours, 48 hours, 30 days, 90 days, and at 1-year post-Ekos therapy. The initial significant reductions in RV/LV continued to improve in all cohorts through 1 year-with mean RV/LV ratios around 0.7 at 1 year for all cohorts. Multiple QOL measurements showed valuable improvements between 30 days and 365 days, further demonstrating the long-term benefit of Ekos therapy, noted the company.
BTG also advised that a separate registry study, KNOCOUT PE, is currently underway to measure how hospitals are adopting and benefiting from the new standard of care. At full enrollment, the KNOCOUT PE study is expected to include as many as 100 centers internationally. Cases will include those from before and after the release of the original OPTALYSE PE study.