Philips announces DEFINE GPS global multicenter study to assess outcomes of PCI procedures guided by integrated iFR and inter...
February 11 2020 - 9:00AM
Philips announces DEFINE GPS global multicenter study to assess
outcomes of PCI procedures guided by integrated iFR and
interventional X-ray images
February 11, 2020
- Randomized controlled trial with up to 3,000 participants at 75
sites to compare outcomes between physiological guidance by iFR
data co-registered on the angiogram (interventional X-ray image)
versus the standard of care use of an angiogram alone
- Percutaneous coronary intervention (PCI) is one of the main
treatment options to open narrowed coronary arteries of the heart
in patients with coronary artery disease
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG,
AEX: PHIA), a global leader in health technology, today announced a
new randomized controlled trial to assess patient outcomes after
receiving a percutaneous coronary intervention (PCI) guided by
Philips’ unique co-registration platform, which combines data of an
instant wave-Free Ratio (iFR) measurement and the angiogram
(interventional X-ray image), compared with today’s standard of
care treatment guided by an angiogram alone. PCI is one of the main
treatment options to open narrowed coronary arteries of the heart
in patients with coronary artery disease.
European and US guidelines already endorse the use of coronary
physiologic measurements with iFR and Fractional Flow Reserve (FFR)
for diagnostic purposes to determine the significance of a narrowed
coronary artery. The DEFINE GPS (Distal Evaluation of Functional
performance with Intravascular sensors to assess the Narrowing
Effect: Guided Physiologic Stenting) study will be the first time
that the use of iFR in conjunction with the Philips Image-Guided
Co-registration System (SyncVision) is evaluated for PCI guidance
and the optimization of treatment outcomes.
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 (coronary
angiography). In the study, an iFR pullback measurement, which uses
pressure wires to map the pressure profile of the disease
distribution along the length of the affected vessel, will be
overlaid on the X-ray image to guide treatment. iFR is a
next-generation physiologic measurement that uses the same pressure
guide wires and equipment as FFR but avoids the administration of
hyperemic agents to patients.
“PCI has made a major positive impact on many coronary artery
disease patients’ lives,” said Allen Jeremias, MD of St. Francis
Hospital, Roslyn, NY, and Cardiovascular Research Foundation, New
York, NY, U.S. and principal investigator of the DEFINE GPS study.
“However, 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 the DEFINE PCI study we observed that the current
approach to PCI has limitations for identifying the locations of
physiologically significant arterial lesions. With DEFINE GPS we
will be able to determine if a physiology-based PCI approach
results in superior patient outcomes when compared with standard
angioplasty.”
“As coronary stenting is applied to increasingly complex
patients, it is essential that we ensure that all segments of
coronary artery disease that need treatment are treated, a process
that we believe can be facilitated by iFR assessment of the entire
coronary artery, co-registered to the angiogram.” said Dr. Gregg W.
Stone, chairman of the DEFINE GPS trial, Director of Academic
Affairs for the for the Mount Sinai Heart Health System, Professor
of Medicine (Cardiology) and Professor of Population Health
Sciences and Policy at the Zena and Michael A. Wiener
Cardiovascular Institute, Icahn School of Medicine at Mount Sinai,
New York, NY. “We are thrilled to be able to examine the extent to
which this technique improves patient outcomes in the large-scale
DEFINE GPS trial.”
The global multicentre, prospective, randomized controlled
DEFINE GPS study will investigate the impact of iFR Co-registration
on both outcomes and cost effectiveness. The primary endpoint is
target vessel failure (a composite of cardiac death, target vessel
Myocardial Infarction and ischemia-driven target vessel
revascularization) or rehospitalization for progressive or unstable
ischemia at two years.
“iFR continues to be adopted into clinical practice, with
mounting evidence that this innovative technology contributes to
improving outcomes, reducing costs [1, 2, 3] and enhancing the
patient experience,” said Chris Landon, Senior Vice President and
General Manager Image Guided Therapy Devices, Philips. “This major
study will provide a definitive answer to the question of the
overall improvement resulting from the use of a functional guidance
strategy on patient outcomes and cost.”
The Philips Image-Guided Co-registration System (SyncVision) is
part of Philips’ unique portfolio of systems, smart devices,
software and services in image-guided therapy, which combine to
provide healthcare providers with sophisticated, procedure-oriented
solutions.
The DEFINE GPS study is sponsored by Philips with the
Cardiovascular Research Foundation overseeing core lab and clinical
event committee activities. The first patients will be recruited in
the second half of 2020.
[1] 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.[2] 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.[3] 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: +31 631 639 916
Email: mark.groves@philips.com Twitter: mark_groves
Fabienne van der FeerPhilips Image Guided TherapyTel: +31 622
698 001Email: fabienne.van.der.feer@philips.com Twitter:
FC_Feer
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health
technology company focused on improving people's health 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 2019
sales of EUR 19.5 billion and employs approximately 80,000
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
Koninklijke Philips NV (EU:PHIA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Koninklijke Philips NV (EU:PHIA)
Historical Stock Chart
From Apr 2023 to Apr 2024