OPTALYSE PE included 101 patients with acute proximal PE at 17 centers randomized to one of four cohorts. All patients received therapeutic anticoagulation along with EKOSⓇ Acoustic Pulse Thrombolysis™ Therapy
BTG plc (LSE: BTG), the global specialist healthcare company, today highlights the results of the OPTALYSE PE trial, presented at the American Thoracic Society International Conference in Washington, D.C. The results show that pulmonary embolism (PE) can be treated effectively with EKOS® over a much shorter period and at safer thrombolytic doses far below the current standard, which will allow for scheduling flexibility and efficiencies in clinician time and drug costs.
OPTALYSE PE included 101 patients with acute proximal PE at 17 centers randomized to one of four cohorts. All patients received therapeutic anticoagulation along with EKOSⓇ Acoustic Pulse Thrombolysis™ Therapy. The first cohort received 4mg per catheter of a standard clot dissolving medication called tissue plasminogen activator (tPA) over 2 hours. The second cohort received 4mg per catheter tPA over 4 hours. The third cohort received 6mg per catheter tPA over 6 hours. The fourth cohort received 12mg per catheter tPA over 6 hours.
All cohorts saw a significant reduction in the main indicator of right heart strain from PE (measured as right ventricular to left ventricular diameter ratio (RV/LV)) by approximately 23 to 26 percent. This is consistent with results achieved in previous EKOS® studies when treatment was applied for 12 to 24 hours. The OPTALYSE PE results also showed a very low bleeding rate of 3% compared to 10% in the previous SEATTLE II study where patients were treated with 24mg for 12 or 24 hours.
Study author Dr. Victor Tapson of the Pulmonary and Critical Care Division at Cedars-Sinai Medical Center in Los Angeles, states, 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.”
The study’s authors include Dr. Tapson; Dr. Gregory Piazza and Dr. Samuel Goldhaber of Brigham and Women’s Hospital, in Boston; Keith Sterling of Inova Alexandria Hospital, Alexandria, Virginia, Dr. Kenneth Ouriel of Syntactx, New York; and Ping-Yu Liu of the Fred Hutchinson Cancer Center, Seattle.
EKOS Vice President and General Manager Matt Stupfel reported, “EKOS® is the only device cleared for the treatment of pulmonary embolism and with the OPTALYSE results, BTG is once again demonstrating our commitment to advancing the treatment of PE.” He concluded, “Now patients can be treated in half the time and half the dose or less, providing greater flexibility to clinicians, improved safety to patients, and potential cost savings to hospitals.”