
In Oct. 2023, Boston Scientific presented results of its REAL-PE study at Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation. The corporation demonstrated that patients treated for pulmonary embolism (PE) with its EKOS Endovascular System (EKOS) had lower rates of adverse events within seven days following their procedure compared to the Inari FlowTriever System.
According to the Centers for Disease Control and Prevention (CDC), approximately 350,000 U.S. patients are affected by PE each year. The condition, in which a blood clot causes a blockage in one or more pulmonary arteries in the lungs, is a leading cause of in-hospital death in the United States. Treatment for PE has historically included anticoagulant medication; however, the development and use of new interventional therapies is increasing. Boston Scientific’s EKOS system, for instance, uses a combination of ultrasound energy and a low thrombolytic drug dose to restore blood flow in patients with PE and other occlusions in the peripheral vasculature.
“In the past decade, there have been a number of advances in interventional therapies for the treatment of PE, but gaps in clinical evidence still exist when it comes to determining the optimal modality for each patient's unique needs,” said Peter Monteleone, MD, FACC, FSCAI, an interventional cardiologist with Ascension and principal investigator of the REAL-PE study. “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.”
REAL-PE is the largest comparative study to use near real-time health system-based electronic health record (EHR) data to understand clinical practices and outcomes related to PE. Researchers reviewed analytics from Truveta, a company that provides EHR data, such as lab values, co-morbidities, images, demographics and clinical outcomes, from more than 30 U.S. health systems and 100 million patients. It also provides information about the performance of specific medical devices.
The research team identified 2,259 patients who experienced PE and received treatment with either the EKOS system or the FlowTriever system between 2009 and 2023. Then, it observed the safety events associated with both devices to form its findings.
- The cohort treated with the EKOS system showed statistically significant reduced rates of major bleeding up to one week post-procedure in comparison to the cohort treated with the FlowTriever system (12.4% vs. 17.3%, according to the International Society on Thrombosis and Haemostasis’s definition of major bleeding).
- Medical coding data demonstrated that post-procedure intracerebral hemorrhage occurred less frequently among patients treated with the EKOS system (0.3% vs. 1.3%).
- All other studied safety events also trended 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%).
- Median lengths of hospital stay were comparable at 3.6 days for both groups.
“Electronic health record data of this scale provides in-depth information about larger, more diverse patient populations, while also accounting for multiple variables including complex medical histories or co-morbidities that often exclude patients from clinical trials,” said Michael R. Jaff, DO, chief medical officer and vice president, Clinical Affairs, Technology and Innovation, Peripheral Interventions, Boston Scientific. “While data from clinical trials and registries will always play an important role in healthcare, access to the breadth of data such as that used in the REAL-PE study has the potential to better inform and accelerate clinical decision-making and, ultimately, improve patient care.”
To date, the EKOS system has been used to treat more than 100,000 patients with PE globally. The next-generation EKOS+ Endovascular System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2022.