Pulmonary Embolism Trial Compares Endovascular Ultrasound to Anticoagulation
February 3, 2014
February 3, 2013 — Ekos Corp., a BTG International group company, published 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), Miami, Fla.
The ULTIMA study is a prospective randomized controlled clinical trial of patients with submassive PE treated with either intravenous anticoagulation or the Ekos EkoSonic Endovascular System and rt-PA. Ekos’ 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 lead author and principal investigator of 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. 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.
For more information: ekoscorp.com