Analysis is first to compare health system-based electronic
health record data for treatment of pulmonary embolism with
interventional devices
MARLBOROUGH, Mass., Oct. 24,
2023 /PRNewswire/ -- Data from the REAL-PE study was
presented today at Transcatheter Cardiovascular Therapeutics (TCT),
the annual scientific symposium of the Cardiovascular Research
Foundation, demonstrating that patients treated for pulmonary
embolism (PE) with the Boston Scientific (NYSE: BSX) EKOS™
Endovascular System (EKOS) had lower rates of adverse events,
including statistically significant lower rates of major bleeding,
within seven days following their procedure compared to the Inari
FlowTriever® System. The analysis 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.
Each year, approximately 350,000 patients in the United States are affected by PE, a blood
clot causing a blockage in one or more pulmonary arteries in the
lungs and a leading cause of in-hospital death in the
U.S. i,ii While treatment for PE
has historically included anticoagulant medication, the use of new
interventional therapies, such as the EKOS system, is
increasing.iii The 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.
The REAL-PE study reviewed data from Truveta, a data and
analytics company that provides EHR data from more than 30 U.S.
health systems and 100 million patients, including lab values,
co-morbidities, images, demographics and clinical outcomes, as well
information about the performance of specific medical devices. In
the REAL-PE analysis, 2,259 patients who experienced PE and
received interventional treatment with either the EKOS system or
the FlowTriever system between 2009 and 2023 were identified, and
safety events associated with both devices were compared.
"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."
Major bleeding events in the REAL-PE study were based on
definitions derived from established clinical criteria and
guidelines, with statistically significant lower rates within seven
days of the procedure consistently found in the cohort of patients
treated with the EKOS system:
- A rate of 12.4% for patients treated with the EKOS system vs.
17.3% for those treated with the FlowTriever system (p=0.0018),
using the International Society on Thrombosis and Haemostasis
(ISTH) definition, and;iv
- A rate of 11.8% for patients treated with the EKOS system vs.
15.4% for those treated with the FlowTriever system (p=0.0190),
using the Bleeding Academic Research Consortium type 3b (BARC3b) definition.v
Medical coding data in the analysis also demonstrated that
intracerebral hemorrhage within seven days following the procedure
occurred statistically significant less frequently among patients
treated with the EKOS system (0.3% vs.1.3%, p=0.005). 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%). 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, D.O., 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, and the next-generation EKOS+™
Endovascular System received U.S. Food and Drug Administration
510(k) clearance in 2022.
More information on the REAL-PE study is available here and on
the EKOS system here.
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology leader
for more than 40 years, we advance science for life by providing a
broad range of high-performance solutions that address unmet
patient needs and reduce the cost of healthcare. For more
information, visit www.bostonscientific.com and connect on Twitter
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CONTACTS:
Blake Rouhani
Media Relations
+1.763.494.2268
Blake.Rouhani@bsci.com
Lauren Tengler
Investor Relations
+1.508.683.4479
BSXInvestorRelations@bsci.com
*Dr. Peter Monteleone is a paid consultant of Boston
Scientific. He has not been compensated in connection with this
press release.
i Centers for Disease Control and Prevention
(CDC). Venous thromboembolism in adult hospitalizations -
United States, 2007-2009. MMWR
Morb Mortal Wkly Rep. 2012;61(22):401-404
ii Sedhom R, Megaly M, Elbadawi A, et al. Contemporary
National Trends and Outcomes of Pulmonary Embolism in the United States. Am J Cardiol.
2022;176:132-138. doi:10.1016/j.amjcard.2022.03.060.
iii Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ,
Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel
C, Barnes GD. Interventional Therapies for Acute Pulmonary
Embolism: Current Status and Principles for the Development of
Novel Evidence: A Scientific Statement From the American Heart
Association. Circulation. 2019;140:e774-801.
iv Definition based on criteria from the
International Society on Thrombosis and Haemostasis: Major bleeding
diagnosis or a hemoglobin decrease ≥2 mg/dL and transfusion.
v Definition based on criteria from the Bleeding
Academic Research Consortium: Major bleeding diagnosis or a
hemoglobin decrease ≥5 mg/dL.
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SOURCE Boston Scientific Corporation