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Bothell, WA, 23 July 2018
BTG plc (LSE: BTG), the global healthcare company, highlighted the publication of OPTALYSE PE trial results in JACC: Cardiovascular Interventions. The published findings further confirm that bilateral pulmonary embolism (PE) treated in as little as 2 hours with EKOS™ Acoustic Pulse Thrombolysis™ therapy shows significant improvement in RV/LV ratio and with a very low one-year mortality rate of 2% and an equally low one-year recurrent PE rate of 2%. This is with considerably less tissue plasminogen activator (tPA) than used in previous studies1, as low as 8mg total.
“The publication of OPTALYSE PE further solidifies these findings as a potential new standard for PE treatment,” said study author Dr. Victor Tapson of the Pulmonary and Critical Care Division at Cedars-Sinai Medical Center in Los Angeles. “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.”
OPTALYSE PE included 101 patients with acute proximal PE at 17 centers randomized to one of four cohorts of EKOS™ therapy. The first cohort received 4mg per device of a standard clot dissolving medication called tissue plasminogen activator (tPA) over 2 hours. The second cohort received 4mg tPA per device over 4 hours. The third cohort received 6mg tPA per device over 6 hours and the fourth cohort received 12mg tPA per device for 6 hours.
All four cohorts saw 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%. This is consistent with previous studies where treatment took place from 12 to 24 hours. 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 24mg for 12 or 24 hours. One-year data from OPTALYSE PE demonstrates improved quality of life of over 30%.
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.
“The published OPTALYSE PE study shows EKOS therapy achieves similar efficacy as previously successful EKOS™ trials, as well as better safety in as little as 2 hours and with low tPA doses,” said Lynn Allen, Vice President of Clinical Affairs for BTG Vascular. “The favorable long-term mortality and QOL data and low recurrent PE rate after EKOS therapy are compelling findings when you consider that treating with systemic thrombolysis or anti-coagulation2, comparable trials have found a one-year mortality at 8% to 10%.”
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.
For further information contact:
Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
Chris Gale, Vice President
+1-646-695-2883; Mobile: +1-203-570-4681
BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer, vascular conditions and severe emphysema. BTG’s Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.