Boston Scientific’s Ekos System Compared With Mechanical Thrombectomy in REAL-PE Study

October 24, 2023—Boston Scientific announced that data from the REAL-PE study demonstrated that patients treated for pulmonary embolism (PE) with the company’s Ekos endovascular system had lower rates of adverse events, including statistically significant lower rates of major bleeding, within 7 days after their procedure compared to the Inari FlowTriever system (Inari Medical, Inc). The analysis used near real-time health system-based electronic health record (EHR) data to understand clinical practices and outcomes related to PE, noted the company.

Boston Scientific’s Ekos system 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.

Peter Monteleone, MD, an interventional cardiologist with Ascension in Austin, Texas, serves as principal investigator of the REAL-PE study. The study data were presented at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

“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,” commented Dr. Monteleone in Boston Scientific’s press release. “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.”

According to Boston Scientific, the REAL-PE study reviewed data from Truveta, a data and analytics company that provides EHR data from more than 30 United States health systems and 100 million patients, including lab values, comorbidities, images, demographics, and clinical outcomes, as well information about the performance of specific medical devices.

In the REAL-PE analysis, investigators identified 2,259 patients who experienced PE and received interventional treatment with either the Ekos system or the FlowTriever system between 2009 and 2023, and compared safety events associated with both devices.

As summarized by the company, major bleeding events in the REAL-PE study were based on definitions derived from established clinical criteria and guidelines. Statistically significant lower rates within 7 days of the procedure were consistently found in the cohort of patients treated with the Ekos system versus FlowTriever, as follows:

• 12.4% versus 17.3% (P = .0018), using the International Society on Thrombosis and Hemostasis definition
• 11.8% versus 15.4% (P = .0190), using the Bleeding Academic Research Consortium type 3b definition.

Additionally, medical coding data in the analysis demonstrated that intracerebral hemorrhage within 7 days after the procedure occurred less frequently with statistical significance among patients treated with the Ekos system (0.3% vs 1.3%; P = .005).

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%).

Finally, median lengths of hospital stay were comparable at 3.6 days for both groups, reported the company.

Michael R. Jaff, DO, who is chief medical officer and vice president, Clinical Affairs, Technology, and Innovation, Peripheral Interventions, at Boston Scientific, stated in the press release, “EHR 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 comorbidities that often exclude patients from clinical trials. 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.”