OPTALYSE PE Long Term Results Reinforce Safety and Efficacy of Shorter, Lower Dose EKOS® Therapy For Pulmonary Embolism
06 February 2018 - 10:00PM
Business Wire
BTG plc (LSE: BTG), the global healthcare company, today
highlighted OPTALYSE PE one year trial results, presented at the
International Society on Endovascular Therapy in Florida. The
findings confirm that bilateral pulmonary embolism patients treated
in as little as 2 hours with a total tissue plasminogen activator
(tPA) dose as low as 8mg continue to show improvements in RV/LV
ratio over the long term with a very low all-cause mortality rate
of 2%, an equally low recurrent PE rate of 2%, and continued
quality of life improvements - further demonstrating the efficacy
and safety of the OPTALYSE PE treatment regimens.
“The long term follow-up results reinforce that a new
interventional standard is being set for PE treatment,” said
principal investigator Victor Tapson, Director, VTE and Pulmonary
Vascular Disease Research Program at Cedars-Sinai Medical Center,
Los Angeles, CA. “The 2% one-year all-cause mortality rate observed
in OPTALYSE PE is much lower than the ~8% rate seen in comparable
anticoagulation studies1. This is important for institutions that
are adopting the new low-dose, shorter duration treatments explored
in OPTALYSE PE.”
The authors followed the 12 month outcomes of 101 patients at 17
centers who participated in the OPTALYSE PE study in which the
patients were randomized one of four cohorts. These patients were
diagnosed with acute proximal PE in at least one main or proximal
lobar pulmonary artery and a right ventricular-to-left ventricular
diameter ratio (RV/LV) greater or equal to 0.9 on chest computed
tomographic angiography (CTA). Patients received treatment within
48 hours of diagnosis. The four cohorts ranged from 2-6 hours in
treatment duration and 8mg to 24mg total tPA for bilateral PE.
All cohorts saw a significant reduction in RV/LV by
approximately 23 to 26 percent taken via CTA at 48 hours. For
follow-up, patients received echocardiograms at four hours, 48
hours, 30 days, 90 days, and at one year post-EKOS therapy. The
initial significant reductions in RV/LV continued to improve in all
cohorts through one year – with mean RV/LV ratios in the 0.70 range
at one year for all cohorts. Multiple quality of life measurements
showed valuable improvements between 30 days and 365 days – further
demonstrating the long-term benefit of EKOS® therapy.
“EKOS is the only device cleared for the treatment of pulmonary
embolism. This is the first time that long-term mortality and
quality of life data has been reported for an interventional PE
treatment, which continues to show our commitment to evidence-based
innovation, predictable and cost-effective procedures, and strong
safety profiles that improve patient outcomes and help make the
most challenging cases easier,” said EKOS Vice President and
General Manager Matt Stupfel. “Within a short time we have seen the
science advance so that patients today can be treated in as little
as 2 hours and with total tPA doses as low as 8mg, providing
greater flexibility to clinicians, improved safety to patients, and
potential cost savings to hospitals at a time when healthcare
systems need these efficiencies.”
A separate registry study, KNOCOUT PE is currently underway to
measure how hospitals are adopting and benefiting from the new
standard of care. At full enrollment, the KNOCOUT PE study is
expected to include as many as 100 centers internationally. Cases
will include those from before and after the release of the
original OPTALYSE PE study. Physicians seeking to participate in
the KNOCOUT PE study or to learn more should contact the BTG IV
Clinical Affairs department.
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 healthcare company focused on Interventional
Medicine. Our innovative medical technology helps physicians treat
their patients through minimally invasive procedures. We have a
growing portfolio of products that advance the treatment of cancer,
vascular conditions and severe emphysema. BTG’s Pharmaceuticals
business provides products that help patients overexposed to
certain medications or toxins. To learn more about BTG, please
visit: btgplc.com.
1. Konstantinides, MD, et al, “Impact of Thrombolytic Therapy on
the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism”
Journal of the American College of Cardiology; vol 69,
pp.1536-1544, 2017.
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