Boston Scientific(BSX) EKOS, the "disruptor" in pulmonary embolism treatment… event incidence reduced by 61%

Boston Scientific’s ‘EKOS’ intravascular therapy system has demonstrated clinical effectiveness that exceeds existing standard treatments in patients with moderate-risk pulmonary embolism (PE). Compared to monotherapy with anticoagulants, it significantly reduces the event rate, and the market is closely watching the potential paradigm shift it may bring to “pulmonary embolism treatment.”

Boston Scientific announced the results of the global randomized clinical trial ‘HI-PEITHO’ on the 28th (local time), indicating that the EKOS system combined with anticoagulants is more effective than single anticoagulant therapy. The results were presented at the annual scientific session of the American College of Cardiology (ACC.26) and published simultaneously in the New England Journal of Medicine (NEJM).

Pulmonary embolism is a condition caused by blood clots blocking the pulmonary arteries and ranks third among causes of cardiovascular death. Current medical guidelines recommend anticoagulants as the standard treatment regardless of risk level. The EKOS system utilizes ultrasound energy to directly deliver medication to the clot, allowing for rapid dissolution of the clot even at low doses, as a minimally invasive treatment device.

This clinical trial was conducted across 59 medical institutions in the United States and Europe, enrolling a total of 544 patients with moderate-risk pulmonary embolism. The primary composite endpoint included PE-related mortality within 7 days, non-fatal deterioration or failure of cardiopulmonary function, and symptomatic recurrence. Analysis showed that the event rate in the EKOS combination therapy group was 4.0%, a 61% reduction compared to the 10.3% in the anticoagulant monotherapy group, with statistical significance (P=0.005).

Notably, the incidence of “deterioration of cardiopulmonary function,” where the heart cannot maintain adequate blood flow, was also lower in the EKOS treatment group (3.7%), which is assessed to have reduced the need for emergency interventions. Additionally, no cases of intracranial hemorrhage were reported during the 30-day follow-up period, and safety was positively validated.

Dr. Stavros Konstantinides, the lead researcher, stated, “The EKOS-based ultrasound-guided thrombus removal has clearly demonstrated clinical efficacy and provided additional benefits of reduced hospital stay without increasing the risk of major bleeding.”

Michael R. Jaff, Chief Medical Officer of Boston Scientific, emphasized, “This study, based on rigorous patient selection and clear clinical objectives, is the first to provide randomized clinical data proving the decisive value of EKOS in ‘acute pulmonary embolism treatment,’ offering interventional specialists and referring physicians a basis for considering it as a first-line treatment option.”

Industry experts believe that these results could expand the applicability of the ‘EKOS system’ in the moderate-risk pulmonary embolism patient population and potentially change the current treatment strategy that centers around anticoagulants. However, long-term follow-up results and cost-effectiveness validation in actual clinical scenarios are seen as key issues for the future.

Comment: The EKOS system has validated its efficacy while confirming safety, and it may establish itself as a new standard treatment option in the pulmonary embolism treatment market in the future.