Philips announces first patient enrolled in the WE-TRUST global
multicenter stroke study to assess the impact of the Direct to
Angio Suite workflow in improving patient outcomes
July 7, 2021
- First patient enrolled in global multi-center randomized
controlled trial with 564 patients at 15 sites comparing the impact
of the Direct to Angio Suite workflow (diagnosis and treatment in
the angio suite) to the conventional workflow (diagnosis in the CT
or MRI suite followed by treatment in the angio suite) on stroke
patient outcomes
- WE-TRUST trial to provide most comprehensive assessment to date
with the help of an advanced brain scan technology in the angio
suite for more effective and efficient stroke patient
outcomes.
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced that the first patient has been enrolled in the WE-TRUST
study at Vall d’Hebron University Hospital, Barcelona, Spain,
marking the official start of this major multicenter randomized
controlled trial to assess if the Direct to Angio Suite workflow
can improve outcomes for early time-window stroke patients (less
than six hours after stroke onset).
The WE-TRUST (Workflow optimization to rEduce Time to
endovascular Reperfusion for Ultra-fast Stroke Treatment) trial
will study the clinical impact of the Direct to Angio Suite
approach, enabled by a special scan in the angio suite developed by
Philips. This approach combines stroke diagnosis and subsequent
treatment in the same angio suite, which the study will compare to
the conventional workflow of diagnosing patients for treatment in
the CT or MRI suite and then treating them in a separate angio
suite. The Direct to Angio Suite approach can potentially reduce
the time to treatment for early time-window stroke patients for
whom every second counts. WE-TRUST will be the first global
multicenter randomized controlled trial to assess the impact of the
Direct to Angio Suite approach. Besides this clinical trial for
early time-window stroke patients, Philips is committed to
optimizing the care pathway for stroke patients in general.
“After suffering a stroke, fast time to treatment is paramount
to giving patients the best possible outcomes. What we will learn
about improving time to treatment in the WE-TRUST trial has the
potential to significantly improve how acute stroke patients are
diagnosed and treated,” said Dr. Raul Nogueira, Director,
Neuroendovascular Service Marcus Stroke and Neuroscience Center at
Grady Health in Atlanta, Georgia, and WE-TRUST Principal
Investigator. “With the help of an advanced brain scan technology
in the angio suite, for example, we intend to eliminate the need
for conventional CT or MRI scans for stroke triage in select
patients to save valuable time.”
This multicenter, prospective, randomized, controlled,
open-label, blinded-endpoint trial is intended to take place at 15
leading strokes sites and aims to enroll more than 560 patients
across the United States, Brazil, Argentina, the Netherlands,
France, Germany, Spain and Turkey. The trial is anticipated to be
completed by 2023.
Stroke is the leading cause of
disabilityGlobally, 1 in 4 adults over the age of 25
will have a stroke in their lifetime [1], and data show that 1
in 200 people are stroke survivors, making acute stroke the second
leading cause of death and a leading cause of serious long-term
disability [2]. Currently, when a possible stroke patient arrives
at the emergency department, they typically first undergo a CT or
MRI exam and, in the case of an ischemic stroke, are then treated
in an interventional suite. Outcomes for stroke patients are
closely tied to how quickly they receive treatment: every 30
minutes’ delay before treatment reduces the chance of a good
outcome by 14% [3], and every hour of delay ages the brain by 3.6
years compared to a normally aging brain [4]. Various single-center
studies have already shown that a Direct to Angio Suite workflow
can result in time-savings up to 54 minutes with improved patient
outcomes after 90 days [5].
Advanced brain scan in the angio suiteThe
Direct to Angio Suite workflow is enabled by an advanced brain scan
in the angio suite, developed by Philips, that uses improved
cone-beam computed tomography (CBCT) to improve image quality and
facilitate triage of patients. This investigational device
reconstructs the stroke CBCT images using specially designed
algorithms and filters to reduce artifacts caused by patient
motion, bone beam hardening and metal objects.
“In a single center randomized clinical trial in our center, the
Direct to Angio Suite workflow has shown a significant improvement
in clinical outcomes in patients who suffered a stroke,” said Dr.
Marc Ribó, WE-TRUST co-Principal Investigator, Interventional
Neurologist at the Vall d’Hebron University Hospital and researcher
at the Stroke Research group at the Vall d’Hebron Research
Institute (VHIR). “With the updated Stroke CBCT investigational
device we can better facilitate triage of patients through improved
image quality.”
“We are very excited to initiate this multicenter study,
partnering with leading stroke centers and physicians to innovate
the diagnosis and treatment of stroke patients,” said Dr. Atul
Gupta, Chief Medical Officer for Image Guided Therapy at Philips.
“The WE-TRUST study is a key milestone, building on Philips’
leading position in image guided therapy and our strong global
network of clinical partnerships. It adds to our deep commitment to
further optimize stroke workflow, remove the hurdles to fast,
decisive treatment, and improve stroke outcomes.”
The trial will primarily be carried out on Philips Image Guided
Therapy System – Azurion – the company’s leading system for
interventional procedures. The primary endpoint of the WE-TRUST
trial is clinical outcome measured by the patients’ functional
status (mRS) three months after the procedure. More information
about the study can be found at wetrust-study.com.
[1]
https://www.world-stroke.org/world-stroke-day-campaign/why-stroke-matters/learn-about-stroke[2]
Centers for Disease Control and prevention
(https://www.cdc.gov/stroke/facts.htm ); Virani SS, Alonso A,
Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart
disease and stroke statistics—2020 update: a report from the
American Heart Associationexternal icon. Circulation.
2020;141(9):e139–e596.
(https://www.ahajournals.org/doi/10.1161/CIR.0000000000000757
)[3] Mazighi, M. et al. Impact of Onset-to-Reperfusion Time on
Stroke Mortality. Circulation 127, 1980-1985,
doi:10.1161/circulationaha.112.000311 (2013).
(https://www.ahajournals.org/doi/10.1161/circulationaha.112.000311)
[4] Saver, J. L. (2006). Time is brain—quantified. Stroke, 37(1),
263-266. (https://www.ncbi.nlm.nih.gov/pubmed/16339467 )[5] Mendez,
B., et al., Direct Transfer to Angio-Suite to Reduce Workflow Times
and Increase Favorable Clinical Outcome. Stroke, 2018. 49(11): p.
2723-2727.
(https://www.ahajournals.org/doi/10.1161/STROKEAHA.118.021989)
For further information, please contact:
Joost MalthaPhilips Global Press OfficeTel: +31 610 558
116Email: joost.maltha@philips.comTwitter: JoostMaltha
Fabienne van der FeerPhilips Image Guided TherapyTel: +31 622
698 001Email: fabienne.van.der.feer@philips.comTwitter: FC_Feer
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health
technology company focused on improving people's health and
well-being, and enabling better outcomes across the health
continuum – from healthy living and prevention, to diagnosis,
treatment and home care. Philips leverages advanced technology and
deep clinical and consumer insights to deliver integrated
solutions. Headquartered in the Netherlands, the company is a
leader in diagnostic imaging, image-guided therapy, patient
monitoring and health informatics, as well as in consumer health
and home care. Philips generated 2020 sales of EUR 17.3 billion and
employs approximately 77,000 employees with sales and services in
more than 100 countries. News about Philips can be found
at www.philips.com/newscenter.
- Vall d'Hebron University Hospital Spain
- Clinical Team Vall d'Hebron
- WE-TRUST logo
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