January 19, 2014
ULTIMA Study Supports EkoSonic System for PE Treatment
January 20, 2014—Ekos Corporation (Bothell, WA), a BTG International group company, announced that the results of the company’s ULTIMA (Ultrasound-Accelerated Thrombolysis of Pulmonary Embolism [PE]) trial were published by Nils Kilcher, MD, et al in Circulation. Dr. Kilcher, who served as principal investigator of the ULTIMA study, is Director of the Venous Thromboembolism Research Group at the University Hospital in Bern, Switzerland.
The company announced the publication at ISET 2014: the International Symposium on Endovascular Therapy in Miami Beach, Florida. In Ekos’ press release, Barry Katzen, MD, who is Course Director of ISET and Medical Director of Baptist Cardiac and Vascular Institute in Miami, commented, “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.”
According to the company, the ULTIMA study is a 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 (alteplase, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany). The Ekos technology uses ultrasound to accelerate the action of clot-dissolving drugs.
As summarized by Ekos, patients in the ULTIMA study who were treated with the EkoSonic 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 EkoSonic group, the mean right ventricular/left ventricular (RV/LV) ratio was reduced from 1.28 ± 0.19 at baseline to 0.99 ± 0.17 at 24 hours (P < .001); in the heparin group, mean RV/LV ratio was 1.2 ± 0.14 and 1.17 ± 0.2, respectively (P = .31). The mean decrease in RV/LV ratio from baseline to 24 hours was 0.3 ± 0.2 versus 0.03 ± 0.16 (P < .001), respectively. There were no serious bleeding events in either group. There was one death in the heparin group within 90 days for reasons other than PE, advised the company.
The company stated that for PE patients at intermediate risk of bad outcomes, the ULTIMA trial demonstrated that treatment with the Ekos EkoSonic system was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications.
Also commenting in the company’s press release, Victor Tapson, MD, Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California, observed, “The ULTIMA study targets a patient population that is underrecognized and undertreated. Findings of the study support the role of the Ekos catheter-based technique as a treatment option for these patients in need.”