Philips announces first patient enrollment in DEFINE GPS global multicenter study to assess superiority of PCI procedures gui...
22 Juin 2021 - 3:00PM
Philips announces first patient enrollment in DEFINE GPS global
multicenter study to assess superiority of PCI procedures guided by
co-registered iFR and interventional angiography
June 22, 2021
- First patient enrolled in global randomized controlled trial
with up to 3,200 participants at 100 sites comparing patient
outcomes after percutaneous coronary intervention (PCI) procedures
guided by iFR data co-registered on the angiogram (interventional
X-ray image) versus the current standard of care, an angiogram
alone
- One of the largest-ever studies sponsored by Philips highlights
company’s commitment to providing a strong evidence base for its
innovations in the pursuit of better patient outcomes, enhanced
patient and staff experiences, and lower cost of care
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced the official start of the DEFINE GPS study, with the
first patient being enrolled by the study’s Principal Investigator,
Dr. Allen Jeremias, at St. Francis Hospital, New York (U.S.). The
global, multi-center, prospective, randomized controlled DEFINE GPS
study will investigate if guidance by instantaneous wave-free ratio
(iFR) measurements co-registered on the angiogram demonstrates
superior outcomes and improves the cost-effectiveness of
percutaneous coronary intervention (PCI) procedures to open blocked
coronary arteries. DEFINE GPS employs an adaptive study design,
estimated to include up to 3,200 participants across 100 sites
worldwide and will be one of the largest studies ever sponsored by
Philips.European and U.S. clinical guidelines already endorse the
use of physiological measurement of coronary function in PCI
procedures, with iFR and fractional flow reserve (FFR) measurements
being used to diagnose the significance of a narrowed coronary
artery and determine patient selection for treatment. While iFR
uses the same pressure guide wires and equipment as FFR, it avoids
the use of hyperemic agents (vasodilators) such as adenosine that
can adversely affect some patients.
The DEFINE GPS (Distal Evaluation of Functional performance with
Intravascular sensors to assess the Narrowing Effect: Guided
Physiologic Stenting) study will evaluate the use of iFR
measurements in combination with Philips Image Guided
Co-Registration System – SyncVision – to enhance PCI guidance
and provide superior treatment outcomes. DEFINE GPS is a follow-up
to the DEFINE PCI study [1] – a one-year trial sponsored by Philips
that evaluated the potential of treating residual ischemia in order
to improve clinical outcomes for coronary stent patients.
“The DEFINE GPS trial, designed to explore the promising
hypotheses that emerged from DEFINE PCI, is a landmark trial that
heralds the promise of post-PCI physiologic assessment,” said Dr.
Gregg W. Stone, Chairman of the DEFINE GPS trial and the Director
of Academic Affairs for the Mount Sinai Heart Health System, New
York. “While the benefits of physiology prior to PCI are
unquestioned, this large-scale trial will definitively demonstrate
whether after an angiographically successful PCI procedure the
identification and treatment of unsuspected residual ischemia by
routine iFR assessment can further improve patient event-free
survival.”
“Conducting rigorous clinical science is how we advance patient
care, and, like the seminal FAME study that was carried out over 10
years ago, I believe DEFINE GPS has the potential to change the
current standard of care in PCI,” said Principal Investigator, Dr.
Allen Jeremias, at St Francis Hospital in Roslyn, New York State.
“PCI has made a major positive impact on many coronary artery
disease patients’ lives, but when we look back at all the major,
high-quality stent trials over the past 20 years we see that around
20-30% of patients continue to have recurring chest pain at one
year after receiving treatment. With DEFINE GPS we will be able to
definitively determine if a physiology-based PCI approach results
in superior patient outcomes compared to standard angioplasty.”
PCI is an image-guided, minimally-invasive treatment to open a
coronary artery blockage (stenosis) that is causing a reduced blood
flow (ischemia) to heart tissue. Under the current standard of
care, clinicians navigate a balloon catheter and coronary stent to
the treatment area using interventional X-ray guidance (a coronary
angiogram). In the DEFINE GPS study, an iFR pullback measurement,
which uses pressure wires to map the physiological profile of
disease distribution along the length of the affected vessel, will
be overlaid on the angiogram to provide more precise information on
where to treat within the vessel. The study will also use iFR to
measure if the treatment succeeds in restoring sufficient blood
flow to prevent ischemia or if further treatment is warranted.
“iFR continues to be adopted in clinical practice, with mounting
evidence that this innovative technology contributes to improved
outcomes, reduced costs [2, 3, 4] and enhanced patient
experiences,” said Chris Landon, Senior Vice President and General
Manager Image Guided Therapy Devices at Philips. “This major study
will provide a definitive answer to the question of whether a
functional guidance strategy throughout the procedure demonstrates
superior outcomes and reduces costs. The study has the potential to
drive a significant improvement in clinical practice, and it’s a
prime example of Philips’ commitment to providing a strong evidence
base for the benefits of its healthcare innovations.”
Philips Image Guided Co-Registration System – SyncVision – is
part of the company’s unique portfolio of systems, smart devices,
software and services available on its Image Guided Therapy System
– Azurion. In addition to advanced imaging systems, the portfolio
includes coronary imaging catheters, coronary atherectomy and
coronary crossing devices, specialty balloons, flow wires, and
pressure wires such as Philips’ new OmniWire – a unique solid-core
pressure wire that enhances the ability to maneuver the wire in the
patient’s circulatory system.
The DEFINE GPS study is sponsored by Philips, with the
Cardiovascular Research Foundation overseeing core lab and clinical
event committee activities.
[1] Jeremias A et al. The DEFINE PCI Trial: Blinded
Physiological Assessment of Residual Ischemia after Successful
Angiographic Percutaneous Coronary Intervention, presented at ACC
2019.[2] Davies JE, et al. Use of the Instantaneous Wave-free Ratio
or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May
11;376(19):1824-1834.[3] Gotberg M, et al. iFR Swedeheart
Investigators. Instantaneous Wave-free Ratio versus Fractional Flow
Reserve to Guide PCI. N Engl J Med. 2017 May
11;376(19):1813-1823.[4] Tonino, et al. Fractional Flow Reserve
Versus Angiography for Guiding Percutaneous Coronary Intervention.
N Engl J Med. 2009;360(3):213-224.
For further information, please contact:
Mark GrovesPhilips Global Press OfficeTel: +31 631 639 916Email:
mark.groves@philips.com
Fabienne van der FeerPhilips Image Guided TherapyTel: +31 622
698 001Email: fabienne.van.der.feer@philips.com
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.
- iFR co-registration with Philips SyncVision
- iFR data co-registered on the angiogram
- Dr. Allen Jeremias and the team at St. Francis Hospital
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