May 22 2017
OPTALYSE PE Study Demonstrates Safety and Efficacy of Shorter, Lower Dose EKOS® Therapy For Pulmonary Embolism
Bothell, Washington, 22 May 2017
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.
“OPTALYSE PE sets a 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. “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® 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,” said EKOS Vice President and General Manager Matt Stupfel. “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.”
About Pulmonary Embolism
Pulmonary Embolism (PE) is a condition that occurs when a piece of a blood clot breaks off from a clot in the legs and travels through the vasculature -- getting trapped in the Pulmonary Arteries. When this happens the clot keeps blood from getting to some areas of the lungs to receive oxygen. This may lead to excessive strain the right side of the heart, ultimately leading to heart failure and/or cardiovascular collapse. PEs can be immediately fatal, but if diagnosed and appropriate therapy started, mortality can be reduced from approximately 30 percent to less than 10 percent.
About the EkoSonic® Endovascular System
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.
In clinical studies EKOS® therapy has been shown to speed time-to-clot dissolution, increase clot removal and enhance clinical improvement compared to either standard catheter-directed drug therapy or thrombectomy. EKOS® therapy requires significantly shorter treatment times and less thrombolytic compared to standard catheter-directed drug therapy, lowering the risk of bleeding and other complications.
About the ULTIMA and SEATTLE II Study
The ULTIMA and SEATTLE II studies were multi-center trials looking at ultrasound-facilitated, low-dose thrombolysis for acute massive and sub-massive pulmonary embolism. ULTIMA, a randomized controlled study compared to anticoagulation, looked at 59 patients across 8 centers and SEATLE II, a prospective single arm study, looked at 150 patients across 22 centers. Identical to OPTALYSE PE, efficacy was measured by a reduction in right heart strain and safety was measured by major bleeding within 72 hours.
Both studies’ results showed that EKOS® Therapy reduced RV/LV ratio by 23% to 25% at 48 hours. The studies concluded that EKOS® therapy for acute PE improves RV function and decreases pulmonary hypertension and angiographic obstruction. By minimizing the risk of intracranial bleed, they represented a potential “game-changer” in the treatment of high-risk PE patients.
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+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
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BTG is a global specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of cancer, severe emphysema, severe blood clots and varicose veins, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: btgplc.com.