OPTALYSE PE Long Term Results Reinforce Safety and Efficacy of Shorter, Lower Dose EKOS® Therapy For Pulmonary Embolism

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Submitted on Tue, 02/06/2018 - 16:58

Bothell, WA, February 2018: BTG plc (LSE: BTG), the global healthcare company, today highlighted OPTALYSE PE one year trial results, presented at the International Society on Endovascular Therapy in Florida. The findings confirm that bilateral pulmonary embolism patients treated in as little as 2 hours with a total tissue plasminogen activator (tPA) dose as low as 8mg continue to show improvements in RV/LV ratio over the long term with a very low all-cause mortality rate of 2%, an equally low recurrent PE rate of 2%, and continued quality of life improvements - further demonstrating the efficacy and safety of the OPTALYSE PE treatment regimens.

 

“The long term follow-up results reinforce that a new interventional standard is being set for PE treatment,” said principal investigator Victor Tapson, Director, VTE and Pulmonary Vascular Disease Research Program at Cedars-Sinai Medical Center, Los Angeles, CA. “The 2% one-year all-cause mortality rate observed in OPTALYSE PE is much lower than the ~8% rate seen in comparable anticoagulation studies1. This is important for institutions that are adopting the new low-dose, shorter duration treatments explored in OPTALYSE PE.”

 

The authors followed the 12 month outcomes of 101 patients at 17 centers who participated in the OPTALYSE PE study in which the patients were randomized one of four cohorts. These patients were diagnosed with acute proximal PE in at least one main or proximal lobar pulmonary artery and a right ventricular-to-left ventricular diameter ratio (RV/LV) greater or equal to 0.9 on chest computed tomographic angiography (CTA). Patients received treatment within 48 hours of diagnosis. The four cohorts ranged from 2-6 hours in treatment duration and 8mg to 24mg total tPA for bilateral PE.

 

All cohorts saw a significant reduction in RV/LV by approximately 23 to 26 percent taken via CTA at 48 hours. For follow-up, patients received echocardiograms at four hours, 48 hours, 30 days, 90 days, and at one year post-EKOS therapy. The initial significant reductions in RV/LV continued to improve in all cohorts through one year – with mean RV/LV ratios in the 0.70 range at one year for all cohorts. Multiple quality of life measurements showed valuable improvements between 30 days and 365 days – further demonstrating the long-term benefit of EKOS® therapy.

 

“EKOS is the only device cleared for the treatment of pulmonary embolism. This is the first time that long-term mortality and quality of life data has been reported for an interventional PE treatment, which continues to show our commitment to evidence-based innovation, predictable and cost-effective procedures, and strong safety profiles that improve patient outcomes and help make the most challenging cases easier,” said EKOS Vice President and General Manager Matt Stupfel. “Within a short time we have seen the science advance so that patients today can be treated in as little as 2 hours and with total tPA doses as low as 8mg, providing greater flexibility to clinicians, improved safety to patients, and potential cost savings to hospitals at a time when healthcare systems need these efficiencies.”

 

A separate registry study, KNOCOUT PE is currently underway to measure how hospitals are adopting and benefiting from the new standard of care. At full enrollment, the KNOCOUT PE study is expected to include as many as 100 centers internationally.  Cases will include those from before and after the release of the original OPTALYSE PE study.  Physicians seeking to participate in the KNOCOUT PE study or to learn more should contact the BTG IV Clinical Affairs department.