OPTALYSE PE Study Evaluates Shorter, Lower-Dose Thrombolysis With Ekos Therapy
May 22, 2017—BTG International announced that the results of the OPTALYSE PE trial showed that pulmonary embolism (PE) can be treated effectively with the company's Ekos EkoSonic endovascular system—an acoustic pulse thrombolysis therapy—during a much shorter period and at safer thrombolytic doses far below the current standard. The findings were presented at the American Thoracic Society International Conference in Washington, DC.
According to the company, the Ekos EkoSonic endovascular system uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs to effectively dissolve clots and restore healthy heart function and blood flow.
OPTALYSE PE included 101 patients with acute proximal PE at 17 centers. Patients were randomized to one of four cohorts, and all patients received therapeutic anticoagulation along with Ekos therapy. The first cohort received 4 mg per catheter of tissue plasminogen activator (tPA) over 2 hours. The second cohort received 4 mg per catheter of tPA over 4 hours. The third cohort received 6 mg per catheter of tPA over 6 hours. The fourth cohort received 12 mg per catheter of tPA over 6 hours.
In all cohorts, there was a significant reduction of approximately 23% to 26% in the main indicator of right heart strain from PE (measured as right ventricular to left ventricular diameter ratio), which is consistent with results achieved in previous Ekos studies when treatment was applied for 12 to 24 hours. Results from OPTALYSE PE also showed a very low bleeding rate of 3% compared to 10% in the previous SEATTLE II study, in which patients were treated with 24 mg for 12 or 24 hours, reported BTG.
Study investigator Victor Tapson, MD, commented in the company's announcement, “OPTALYSE PE sets a new standard for PE treatment. This trial builds on a growing body of clinical evidence, including the ULTIMA and SEATTLE II studies, showing a significant reduction in right heart strain with shorter treatment durations and lower tPA doses. In addition to moving patients out of danger more quickly, hospitals can potentially save significant intensive care, drug and clinician time, and cost due to increased safety and shorter treatment durations.” Dr. Tapson is from the Pulmonary and Critical Care Division at Cedars-Sinai Medical Center in Los Angeles, California.