OPTALYSE PE Results Published in JACC: Cardiovascular Interventions
23 July 2018 - 9:49PM
Business Wire
BTG plc (LSE: BTG), the global healthcare company, highlighted
the publication of OPTALYSE PE trial results in JACC:
Cardiovascular Interventions. The published findings further
confirm that bilateral pulmonary embolism (PE) treated in as little
as 2 hours with EKOSⓇ Acoustic Pulse Thrombolysis™ therapy shows
significant improvement in RV/LV ratio and with a very low one-year
mortality rate of 2% and an equally low one-year recurrent PE rate
of 2%. This is with considerably less tissue plasminogen activator
(tPA) than used in previous studies1, as low as 8mg total.
“The publication of OPTALYSE PE further solidifies these
findings as a potential new standard for PE treatment,” said study
author Dr. Victor Tapson of the Pulmonary and Critical Care
Division at Cedars-Sinai Medical Center in Los Angeles. “The body
of clinical evidence, including the ULTIMA and SEATTLE II studies,
reveals an opportunity to advance PE patient care with more
flexible and efficient deployment of intensive care, drug and
clinician time, along with enhanced safety and speed.”
OPTALYSE PE included 101 patients with acute proximal PE at 17
centers randomized to one of four cohorts of EKOS® therapy. The
first cohort received 4mg per device of a standard clot dissolving
medication called tissue plasminogen activator (tPA) over 2 hours.
The second cohort received 4mg tPA per device over 4 hours. The
third cohort received 6mg tPA per device over 6 hours and the
fourth cohort received 12mg tPA per device for 6 hours.
All four cohorts saw 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%. This is consistent with previous studies where treatment took
place from 12 to 24 hours. The OPTALYSE PE results included a very
low bleeding rate of 3% compared to 10% in the SEATTLE II study, in
which patients received treatment with 24mg for 12 or 24 hours.
One-year data from OPTALYSE PE demonstrates improved quality of
life of over 30%.
The study’s authors include Dr. Tapson; Dr. Gregory Piazza and
Dr. Samuel Goldhaber of Brigham and Women’s Hospital, in Boston;
Keith Sterling of Inova Alexandria Hospital, Alexandria, Virginia,
Dr. Kenneth Ouriel of Syntactx, New York; and Ping-Yu Liu of the
Fred Hutchinson Cancer Center, Seattle.
“The published OPTALYSE PE study shows EKOS® therapy achieves
similar efficacy as previously successful EKOS trials, as well as
better safety in as little as 2 hours and with low tPA doses,” said
Lynn Allen, Vice President of Clinical Affairs for BTG Vascular.
“The favorable long-term mortality and QOL data and low recurrent
PE rate after EKOS therapy are compelling findings when you
consider that treating with systemic thrombolysis or
anti-coagulation2, comparable trials have found a one-year
mortality at 8% to 10%.”
A separate registry study underway, KNOCOUT PE is intended to
measure how institutions are adopting OPTALYSE PE and this new
standard of care. The study is expected to include as many as 100
centers globally and is currently enrolling.
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.
Product availability varies by country. Caution: Federal (USA)
law restricts this device to sale by or on the order of a
physician. Prior to use, please refer to the applicable
Instructions for Use (IFU) for complete product indications,
contraindications, warnings, and precautions.
About the OPTALYSE PE, ULTIMA and SEATTLE II studies
The OPTALYSE PE, ULTIMA and SEATTLE II studies prospective
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 and
proved that the EKOS® regiment was superior to anticoagulation
alone.
SEATTLE II, a prospective single arm study, looked at 150
patients across 22 centers and demonstrated improvement in RV/LV
ratio, pulmonary hypertension and angiographic obstruction with
EKOS® therapy.
OPTALYSE PE included 101 patients with acute proximal PE at 17
centers randomized to one of four treatment cohorts – with cohorts
ranging between 2-6 hours in treatment duration and from 4-6mg/tpA
total per device. 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. Beyond the acute
results, echocardiograms were provided at four hours, 48 hours, 30
days, 90 days, and at one year post-therapy. The initial
significant reductions in RV/LV continued to improve in all cohorts
through one year. Multiple quality of life measures showed key
improvements.
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.
- Piazza, G., et al., A Prospective,
Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Low-Dose
Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism:
the Seattle II study.” Journal of the American College of
Cardiology: Cardiovascular Interventions 2015; 8: 1382-92.
- 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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