Ekos Announces Results of DUET Study

April 15, 2013—Ekos Corporation (Bothell, WA) announced the results of the DUET multicenter, randomized trial comparing ultrasound-accelerated, catheter-directed thrombolysis (USAT) to standard side-hole, catheter-directed thrombolysis (CDT) for the treatment of acute peripheral arterial thrombotic occlusions. Jean-Paul de Vries, MD, presented the DUET results at the 35th Annual Charing Cross International Symposium in London, United Kingdom. Dr. de Vries is Head of the Department of Vascular Surgery at St. Antonius Hospital in Nieuwegein, The Netherlands.

The DUET study enrolled 60 patients at four medical centers in The Netherlands. Of these patients, 28 were randomly selected for treatment with the Ekos system, which generates ultrasound energy while simultaneously delivering a low dose of the thrombolytic drug, urokinase. The company stated that the ultrasound conditions the clot and allows for more effective delivery of the drug, aiming for faster and more complete clot dissolution.

Ekos noted that all 60 patients in the study were selected to represent the most challenging examples of arterial thromboembolic infrainguinal disease with symptom duration between 1 and 7 weeks. Average duration of symptoms was 19 days in both groups. All other factors, including average clot length and coexisting disease, also appeared similarly in both groups.

The company reported that despite challenges in placing catheters in these patients, technical success was achieved in 80% of all cases. The hourly thrombolytic drug dose rate was identical for both groups and angiograms were obtained every 6 hours (except overnight). The images were reviewed by an independent data safety monitoring board to determine when uninterrupted flow had been established and all thrombus (> 95%) was removed. On average, patients treated with USAT were completed 12 hours sooner than those treated with standard CDT.

“If this new technology could reduce treatment by 12 hours compared to standard CDT, then the additional device cost would be more than offset by savings in hospital and personnel time,” commented Dr. de Vries in the company's announcement. “An additional bonus would be if the incidence of bleeding associated with clot dissolving drugs could be reduced.”

“Our study objectives were met. Ekos significantly reduces treatment time with no increase of serious adverse events.” Dr. de Vries also added that plans are underway to commence the DUET II study, which will be a nonrandomized trial using the Ekos system and lower hourly drug dose with an expectation of further reducing bleeding complications.

“The DUET results confirm our years of experience using the Ekos system; that ultrasound-assisted thrombolysis reduces treatment times and associated thrombolytic drug dose,” explained Barry Katzen, MD, Medical Director of Baptist Cardiac and Vascular Institute in Miami, Florida.