Pulmonary Embolism Trial Comparing Endovascular Ultrasound to Anticoagulation Published
EKOS Corporation, a BTG International group company, located in Bothell, Washington in the United States, today announced the publication of the results of its Ultrasound Accelerated Thrombolysis of Pulmonary Embolism (PE) trial (ULTIMA) in the peer-reviewed journal of the American Heart Association, CIRCULATION. The announcement was made at The International Symposium on Endovascular Therapy (ISET) in Miami, Florida in the United States .
The ULTIMA study is the world’s first and only prospective randomized controlled clinical trial of patients with submassive PE treated with either standard of care intravenous anticoagulation or the EKOS EkoSonic Endovascular System and rt-PA (Actilyse, Boehringer Ingelheim). EKOS’ unique technology uses ultrasound to accelerate the action of clot-dissolving drugs. Dr. Nils Kucher, Director of the Venous Thromboembolism Research Group at the University Hospital in Bern, Switzerland, is the lead author and principal investigator of the ULTIMA study.
In the ULTIMA study, patients treated with the EKOS EkoSonic Endovascular System demonstrated a statistically significant reduction in right heart strain within 24 hours with no adverse effects from the catheterization, whereas the patients treated only with the anticoagulant heparin showed no significant improvement. In the EKOS group, the mean RV/LV ratio was reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (p<0.001); in the heparin group, mean RV/LV ratio was 1.20±0.14 and 1.17±0.20, respectively (p=0.31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.30±0.20 versus 0.03±0.16 (p<0.001), respectively. There were no serious bleeding events in either group. There was one death in the non-EKOS group within 90 days for reasons other than PE.
For PE patients at intermediate risk of bad outcomes, the ULTIMA trial demonstrated that EKOS treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications.
Dr. Barry Katzen, Medical Director, Baptist Cardiac and Vascular Institute (Miami, FL), said, “The outcome and safety data are compelling. This study suggests we should be employing a more aggressive therapeutic approach to these patients with life threatening pulmonary emboli.”
Dr. Victor Tapson, Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, commented, “The ULTIMA study targets a patient population that is under-recognized and under-treated. Findings of the study support the role of the EKOS catheter-based technique as a treatment option for these patients in need.”
Matt Stupfel, General Manager at EKOS Corporation, added, “PE occurs in approximately 1 million patients in Europe annually (600,000 in the US), causing or contributing to 200,000 deaths each year.” Stupfel concluded, “The findings in this study will give hope to patients worldwide who may face chronic pulmonary hypertension or death, if inadequately treated.”