Boston Scientific’s EkoSonic System Studied With Anticoagulation in HI-PEITHO Trial

August 4, 2021—Boston Scientific Corporation announced that it has commenced enrollment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz, Germany.

According to Boston Scientific, the HI-PEITHO trial is evaluating the use of the company's EkoSonic endovascular system (Ekos) in combination with anticoagulation compared to anticoagulation alone for the treatment of acute, intermediate-high-risk pulmonary embolism (PE). More information is provided on the company’s web page for the trial, here.

The trial will assess whether treatment with the Ekos system in combination with anticoagulation is associated with a significant reduction in adverse events compared to anticoagulation alone within 7 days of randomization. The composite primary endpoint is defined as PE-related mortality, cardiorespiratory decompensation or collapse, and non-fatal symptomatic and objectively confirmed recurrence of PE.

The randomized controlled trial will enroll up to 544 patients with confirmed acute, intermediate-high-risk PE at as many as 65 sites in the United States and Europe. Patients will be followed for 1 year.

Ekos uses ultrasound energy in combination with a thrombolytic drug to dissolve blood clots and restore blood flow in patients with PE and peripheral arterial occlusions. The device’s ultrasound technology accelerates thrombolysis, thereby minimizing the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can result in optimized outcomes and a lower risk of bleeding, stated the company.

Stavros Konstantinides, MD, and Kenneth Rosenfield, MD, are the study’s co-lead principal investigators. Dr. Konstantinides is Professor and Medical Director, Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University of Mainz, Germany. Dr. Rosenfield is Section Head, Vascular Medicine and Intervention, Division of Cardiology, Massachusetts General Hospital in Boston, Massachusetts.

“I am honored to be part of this study's global leadership whose mission is to bring forth guideline-informing data that will ensure physicians can feel confident in the most appropriate strategy for treating patients with intermediate-high-risk PE,” commented Dr. Konstantinides in Boston Scientific's announcement.

Dr. Rosenfield added, “Optimal treatment of PE is still poorly understood and there is a need for a coordinated institutional approach to this complex, life-threatening problem. The lead investigators of the trial are pleased to collaborate with the PERT Consortium, which is committed to evidence-driven therapy and is proud to take part in the HI-PEITHO study, aiming to advance the care of patients with PE.”