Centers Commence Enrollment in KNOCOUT PE Study to Measure the Impact of Shorter, Even Safer EKOS® Therapy Protocols for Pul...
December 14 2017 - 11:03AM
Business Wire
BTG plc (LSE: BTG), the global specialist healthcare company,
today highlights the commencement of the KNOCOUT PE study. The
KNOCOUT PE study will measure how hospitals and patients are
benefitting from a new standard of care in the treatment of
Pulmonary Embolism utilizing EKOS® therapy with faster, and even
safer protocols, proven effective in the OPTALYSE PE study.
Presented in May, the OPTALYSE PE study found pulmonary embolism
(PE) can be treated effectively with EKOS® therapy over a much
shorter period and at safer thrombolytic doses far below the
previous standard.
“We are excited to launch a large international registry of EKOS
use including the duration of ultrasound and the dose of
thrombolytic, in submassive PE. KNOCOUT PE permits a review of how
interventionalists are implementing the OPTALYSE PE protocols and
the results they are finding in real world practice,” said BTG Vice
President of Clinical Development Lynn Allen. “This importantly
expands our clinical evidence to understand how clinical study
findings such as these are adopted and what new best practices can
be shared.”
At full enrollment, KNOCOUT PE is expected to include up to 100
centers internationally. Cases will include those from before and
after the release of the OPTALYSE PE study.
“The results of the OPTALYSE PE trial suggest that a new
standard for PE treatment might be adopted, the question is how are
institutions adjusting to these new low dose, shorter duration
treatments and what are they finding,” said KNOCOUT PE principal
investigator Keith Sterling of Inova Alexandria Hospital,
Alexandria, Virginia. “KNOCOUT PE accelerates the sharing and
learning process and continues to build on the body of clinical
evidence, including the ULTIMA and SEATTLE II studies.”
Physicians seeking to participate or to learn more should
contact their local BTG sales representative.
About Pulmonary Embolism
Pulmonary Embolism (PE) is a condition that occurs when a piece
of a blood clot breaks off from a clot in the legs and travels
through the vasculature -- getting trapped in the Pulmonary
Arteries. When this happens the clot keeps blood from getting to
some areas of the lungs to receive oxygen. This may lead to
excessive strain on the right side of the heart, ultimately leading
to heart failure and/or cardiovascular collapse. PEs can be
immediately fatal, but if diagnosed and appropriate therapy
started, mortality can be reduced from approximately 30 percent to
less than 10 percent.
About the EkoSonic® Endovascular System
The EKOS® system uses ultrasonic waves in combination with
clot-dissolving thrombolytic drugs to effectively dissolve clots
and restore healthy heart function and blood flow.
In clinical studies, EKOS® therapy has been shown to speed
time-to-clot dissolution, increase clot removal and enhance
clinical improvement compared to either standard catheter-directed
drug therapy or thrombectomy. EKOS® therapy requires significantly
shorter treatment times and less thrombolytic compared to standard
catheter-directed drug therapy, lowering the risk of bleeding and
other complications.
About the OPTALYSE PE, ULTIMA and SEATTLE II studies
The OPTALYSE PE, ULTIMA and SEATTLE II studies were multi-center
trials examining ultrasound-facilitated, catheter-directed
thrombolysis using a low dose of a standard clot dissolving
medication called tissue plasminogen activator (tPA) to treat both
acute massive and submassive pulmonary embolism. ULTIMA, a
randomized controlled study comparing EKOS® therapy to
anticoagulation, looked at 59 patients across eight centers.
SEATTLE II, a prospective single arm study, looked at 150 patients
across 22 centers. OPTALYSE PE included 101 patients with acute
proximal PE at 17 centers randomized to one of four treatment
cohorts. The first cohort received 4mg of tPA per catheter over two
hours. The second cohort received 4mg of tPA per catheter over four
hours. The third cohort received 6mg of tPA per catheter over six
hours. The fourth cohort received 12mg of tPA per catheter over six
hours.
All cohorts saw a significant reduction in the main indicator of
right heart strain from PE (measured as right ventricular to left
ventricular diameter ratio (RV/LV)) by approximately 23 to 26
percent. The OPTALYSE PE results also showed a very low bleeding
rate of three percent compared to 10 percent in the previous
SEATTLE II study where patients were treated with 24mg for 12 or 24
hours.
About BTG
BTG is a global specialist healthcare company bringing to market
innovative products in specialist areas of medicine to better serve
doctors and their patients. We have a portfolio of Interventional
Medicine products to advance the treatment of cancer, severe
emphysema, severe blood clots and varicose veins, and Specialty
Pharmaceuticals that help patients overexposed to certain
medications or toxins. Inspired by patient and physician needs, BTG
is investing to expand its portfolio to address some of today’s
most complex healthcare challenges. To learn more about BTG, please
visit: btgplc.com. NA-EKO-2017-0496
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CommunicationsChris Gale, Vice President+1-646-695-2883;
Mobile: +1-203-570-4681
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