OPTALYSE PE Results Published in JACC: Cardiovascular Interventions

“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.

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.

Product availability varies by country. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Prior to use, please refer to the applicable Instructions for Use (IFU) for complete product indications, contraindications, warnings, and precautions.

About the OPTALYSE PE, ULTIMA and SEATTLE II studies

The OPTALYSE PE, ULTIMA and SEATTLE II studies prospective multi-center trials examining ultrasound-facilitated, catheter-directed thrombolysis using a low dose of a standard clot dissolving medication called tissue plasminogen activator (tPA) to treat both acute massive and submassive pulmonary embolism.

ULTIMA, a randomized controlled study comparing EKOS^® therapy to anticoagulation, looked at 59 patients across eight centers and proved that the EKOS^® regiment was superior to anticoagulation alone.

SEATTLE II, a prospective single arm study, looked at 150 patients across 22 centers and demonstrated improvement in RV/LV ratio, pulmonary hypertension and angiographic obstruction with EKOS^® therapy.

OPTALYSE PE included 101 patients with acute proximal PE at 17 centers randomized to one of four treatment cohorts – with cohorts ranging between 2-6 hours in treatment duration and from 4-6mg/tpA total per device. 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. The OPTALYSE PE results also showed a very low bleeding rate of three percent. Beyond the acute results, echocardiograms were provided at four hours, 48 hours, 30 days, 90 days, and at one year post-therapy. The initial significant reductions in RV/LV continued to improve in all cohorts through one year. Multiple quality of life measures showed key improvements.

About BTG

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.

1. Piazza, G., et al., A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: the Seattle II study.” Journal of the American College of Cardiology: Cardiovascular Interventions 2015; 8: 1382-92.
2. Konstantinides, MD, et al, “Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism” Journal of the American College of Cardiology; vol 69, pp.1536-1544, 2017.