OPTALYSE PE Evaluates Ekos System to Treat Bilateral Pulmonary Embolism

May 1, 2018—BTG International announced that results from the OPTALYSE PE trial of the company's EkoSonic endovascular system for the treatment of bilateral pulmonary embolism (PE) were presented at the Society for Cardiovascular Angiography and Interventions scientific sessions, held April 25–28 in San Diego, California.

According to the company, the findings confirm that treatment with the Ekos system—for as little as 2 hours and with significantly less tissue plasminogen activator (tPA) than used in previous studies (as low as 8 mg total)—results in significant improvement in right ventricular–to–left ventricular (RV/LV) diameter ratio in both the short and long term with a low mortality rate of 2% and a low recurrent PE rate of 2%. Additionally, the 1-year data from OPTALYSE PE demonstrate improved quality of life of > 30% using two unique measurement systems.

As summarized by BTG, OPTALYSE PE included 101 patients with acute proximal PE at 17 centers randomized to one of four treatment cohorts—with cohorts ranging between 2 and 6 hours in treatment duration and 4 to 6 mg tPA total per device. In results presented in May 2017 at the American Thoracic Society international conference, all cohorts saw a significant reduction in the main indicator of right heart strain from PE by approximately 23% to 26%. The OPTALYSE PE results also showed a low bleeding rate of 3%. Beyond the acute results, echocardiography was performed at 4 hours, 48 hours, 30 days, 90 days, and at 1 year after therapy. The initial significant reductions in RV/LV continued to improve in all cohorts through 1 year and multiple quality-of-life measures showed key improvements.

BTG advised that a separate registry study, 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. Other studies of the Ekos system include ULTIMA, which demonstrated that the Ekos therapy was superior to anticoagulation alone, and SEATTLE II, which demonstrated improvement in RV/LV ratio, pulmonary hypertension, and angiographic obstruction with Ekos therapy.

In the company's announcement, Gregory Piazza, MD, announced, “Ekos is the only endovascular device cleared by the US Food and Drug Administration for the treatment of PE. We are constantly in need of more data to help drive decision-making in PE. So far, the most data that exists in PE is associated with Ekos therapy and the data provided in the OPTALYSE study advances the science of PE treatment even further.”