MARLBOROUGH, Mass.,
Aug. 4, 2021 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) has commenced enrollment in the
HI-PEITHO clinical trial, a collaborative research study with the
Pulmonary Embolism Response Team (PERT) Consortium and the
University Medical Center of the Johannes Gutenberg University of
Mainz comparing use of the EkoSonic™ Endovascular System (EKOS) in
combination with anticoagulation to anticoagulation alone for the
treatment of acute, intermediate-high-risk pulmonary embolism
(PE).
Each year nearly one million patients in the U.S. and
Europe are affected by PE, a blood
clot causing a blockage in one or more pulmonary arteries within
the lungs, representing the leading cause of in-hospital death in
the United
States.i,ii In intermediate-risk or
high-risk cases of PE, the blockage may lead to a strain on the
heart's ability to pump blood through the lungs and can be fatal.
The current standard of care for PE is anticoagulation, though
there are disparate guidelines to direct safe and effective
treatment of patients with intermediate-high-risk PE.
"This first-of-its-kind international randomized controlled
trial is intended to address current gaps in clinical guidelines
and underscores our support of the highest level of research that
may enable physicians to make data-based clinical decisions when
choosing the best therapy for their patients with PE," said
Michael R. Jaff, D.O., chief medical
officer and vice president clinical affairs, technology and
innovation, Peripheral Interventions, Boston Scientific.
The EKOS system uses ultrasound energy in combination with a
thrombolytic drug to dissolve blood clots and restore blood flow in
patients with PE and peripheral arterial occlusions. The ultrasound
technology used by the EKOS system accelerates thrombolysis – the
breakdown of the clot – minimizing the time it takes to treat a
patient and lowering the necessary thrombolytic dose, which can
result in optimized outcomes and a lower risk of bleeding.
"I am honored to be part of this study's global leadership whose
mission is to bring forth guidelines-informing data that will
ensure physicians can feel confident in the most appropriate
strategy for treating patients with intermediate-high-risk PE,"
said Stavros Konstantinides M.D.,
Ph.D., FESC, FRCP (Glasg.), study co-lead principal investigator,
professor and medical director, Center for Thrombosis and
Hemostasis, University Medical Center of the Johannes Gutenberg
University of Mainz, Germany.
The randomized HI-PEITHO trial will enroll up to 544 patients
with confirmed acute, intermediate-high-risk PE at as many as 65
sites in the U.S. and Europe. The
trial, which will follow patients for one year, will assess whether
treatment with the EKOS system in combination with anticoagulation
is associated with a significant reduction in adverse events
compared to anticoagulation alone, within seven days of
randomization. The composite primary endpoint is defined as
PE-related mortality, cardiorespiratory decompensation or collapse
and non-fatal symptomatic and objectively confirmed recurrence of
PE.
"Optimal treatment of PE is still poorly understood and there is
a need for a coordinated institutional approach to this complex,
life-threatening problem," said Kenneth
Rosenfield, M.D., study co-lead principal investigator and
section head, Vascular Medicine and Intervention, Division of
Cardiology, Massachusetts General Hospital, Boston. "The lead investigators of the trial
are pleased to collaborate with the PERT Consortium, which is
committed to evidence-driven therapy and is proud to take part in
the HI-PEITHO study, aiming to advance the care of patients with
PE."
To learn more about the HI-PEITHO clinical trial, please visit
https://www.bostonscientific.com/hi-peitho.
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 and connect on
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CONTACTS:
Karin Dalsin
Media Relations
(763) 494-1914
Karin.Dalsin@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
i Wood KE et al. Major pulmonary embolism: review of
a pathophysiologic approach to the golden hour of hemodynamically
significant pulmonary embolism. Chest 2002;121:877-905
ii Management strategies and determinants of outcome
in acute major pulmonary embolism: results of a multicenter
registry. Kasper et al., J Am Coll Cardiol, 1997; 30: 1165-1171
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SOURCE Boston Scientific Corporation