Therapeutic ultrasound developer Ekos is highlighting results of its ultrasound-accelerated thrombolysis of pulmonary embolism (PE) trial (ULTIMA).
ULTIMA was 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 recombinant tissue plasminogen activator (rt-PA), according to the vendor. Ekos uses ultrasound to accelerate the action of clot-dissolving drugs.
Patients treated with the Ekos 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, according to results published in Circulation (November 13, 2013).
In the EkoSonic group, the mean right-ventricle/left-ventricle (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-EkoSonic group within 90 days for reasons other than PE.
For PE patients at intermediate risk of bad outcomes, ULTIMA demonstrated that treatment with the Ekos system was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications, Ekos said.
