Results of ULTIMA Trial Support Use of Ultrasound Accelerated Thrombolysis for Submassive PE

March 9, 2013—Results of the ULTIMA (Ultrasound Accelerated Thrombolysis of Pulmonary Embolism) trial, the first randomized, controlled trial comparing use of an endovascular approach with anticoagulation to treat submassive pulmonary embolism (PE) versus anticoagulation alone, were presented at the 62nd annual scientific session of the American College of Cardiology in San Francisco, California. Principal Investigator Nils Kucher, MD, of University Hospital in Bern, Switzerland, presented the data.

The 59-patient study was conducted at eight centers in Europe. Thirty patients were randomly selected and treated with the EkoSonic ultrasound accelerated infusion catheter (Ekos Corporation, Bothell, WA) and anticoagulation. All patients' heart function were measured before and 24 hours after therapy. Patients treated with the Ekos catheter demonstrated statistically significant reduction in right heart enlargement at 24 hours (improvement in RV/LV ratio, 23%; P < .0001) with no adverse effects from the catheterization. Anticoagulation-only patients had an average improvement of 3%, and there was one death for reasons other than PE. There were no serious bleeding events in either group.

The Ekos-treated group also experienced a greater reduction in right heart dysfunction at 90 days than patients treated with only anticoagulation (P < .0001).

“The crucial result of this study is that we didn't have a single patient with bleeding. Usually with systemic thrombolysis, we see up to 20% of patients with major bleedings,” said Dr. Kucher in comments to Endovascular Today. He explained that the next steps for the technology will be to compare results of the SEATTLE II—a prospective, single-arm, multicenter trial of the Ekosonic system—and to conduct a large phase 3 study. “If SEATTLE II confirms that the bleeding is truly that low, then I believe it will convince many physicians to use this technology.”