Boston Scientific Reports Results From Electronic Health Record Study Showing EKOS Has Lower Adverse Event Rate Compared to Inari’s FlowTriever System
A recent study presented at the Transcatheter Cardiovascular Therapeutics (TCT) symposium, conducted by the Cardiovascular Research Foundation, reveals that patients treated for pulmonary embolism (PE) with Boston Scientific’s EKOS™ Endovascular System (EKOS) experienced lower rates of adverse events, including significantly fewer incidents of major bleeding within seven days post-procedure compared to the Inari FlowTriever® System. The analysis stands as the largest comparative study employing near real-time health system-based electronic health record (EHR) data to comprehend clinical practices and outcomes related to PE.
Pulmonary embolism, a condition involving blood clots obstructing one or more pulmonary arteries in the lungs, affects approximately 350,000 U.S. patients each year and remains a leading cause of in-hospital mortality in the country. While traditional PE treatment consists of anticoagulant medications, interventional therapies like the EKOS system are gaining popularity. The EKOS system combines ultrasound energy and low thrombolytic drug dosages to restore blood flow in PE patients and those with other peripheral vascular occlusions. Inari’s FlowTriever system uses both mechanical and aspiration mechanisms to remove clots causing pulmonary embolisms.
The REAL-PE study analyzed data from Truveta, a data and analytics company that aggregates EHR data from over 30 U.S. health systems and 100 million patients, including lab values, co-morbidities, images, demographics, clinical outcomes, and medical device performance information. In this analysis, researchers identified 2,259 PE patients who underwent interventional treatment with either the EKOS system or the FlowTriever system between 2009 and 2023, and compared safety events associated with both devices.
The study found that major bleeding events within seven days of the procedure were notably lower among patients treated with the EKOS system with a 12.4% rate for patients treated with the EKOS system compared to 17.3% with the FlowTriever system, based on the International Society on Thrombosis and Haemostasis (ISTH) definition. Looking at another methodology, rates were 11.8% rate for patients treated with the EKOS system compared to 15.4% with the FlowTriever system, according to the Bleeding Academic Research Consortium type 3b (BARC3b) definition.
The data also showed that intracerebral hemorrhage within seven days following the procedure also occurred less frequently among patients treated with the EKOS system (0.3% vs. 1.3%, p=0.005). Other safety events studied were also in favor of the EKOS system, including in-hospital mortality (2.6% vs. 3.7%) and all-cause 30-day readmission rates (5.1% vs. 5.4%). The median lengths of hospital stays were comparable for both groups at 3.6 days.
Last year at TCT, Inari presented data from its FLASH registry, a real-world study that assessed patient outcomes following pulmonary embolism (PE) treatment using the FlowTriever system. The study’s primary endpoint looked at adverse events, which included device-related mortality, major bleeding within 48 hours, and device/procedure-related acute events, was found to be low at 1.8%. Patients experienced rapid improvement in hemodynamics and symptoms, resulting in minimal requirements for additional treatment and a median post-procedure ICU stay of zero days. The 30-day all-cause mortality rate was only 0.8% in the registry study.
Dr. Peter Monteleone, an interventional cardiologist with Ascension and the principal investigator of the REAL-PE study, commented on the significance of this research, stating, “The REAL-PE study provides comprehensive data and unprecedented insight into the real-world performance of specific interventional devices, which can help physicians make more informed clinical decisions.”
The EKOS system, which has been used to treat over 100,000 PE patients worldwide, received U.S. Food and Drug Administration 510(k) clearance for its next-generation EKOS+™ Endovascular System in 2022.