AMSTERDAM and WASHINGTON, March 18,
2017 /PRNewswire/ -- Royal Philips (NYSE: PHG,
AEX: PHIA) today announced that the results from two large
clinical trials comparing patient outcomes using instant wave-free
ratio (iFR) and fractional flow reserve (FFR) in the diagnosis and
treatment of heart disease have been published in the New England
Journal of Medicine. First released in 2013, iFR is an innovative
pressure-derived index unique to Philips, a global leader in
image-guided therapy solutions, allowing hyperemia-free
physiological assessment of coronary blockages.
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Findings from the DEFINE FLAIR and iFR Swedeheart trials, which
studied 4,529 patients as part of the largest randomized coronary
physiology outcome studies to date, were presented at the 2017
American College of Cardiology's Annual Scientific Session &
Expo (ACC.17) in Washington, D.C.,
March 17–19, 2017. Investigators Dr. Justin
Davies of Imperial College London in the United Kingdom, and Dr. Matthias Götberg of Lund University in Sweden, presented one-year outcome data
showing that, compared to an FFR-guided strategy, an iFR-guided
strategy offers a more cost-effective and faster diagnostic
solution with reduced patient discomfort, while delivering
consistent patient outcomes.
"Findings from these two major clinical outcome studies have the
potential to significantly improve the use of coronary
physiological assessment," said Dr. Manesh
Patel, MD, FACC, FSCAI, Chief of the Division of Cardiology
and Co-Director of the Duke Heart Center at Duke University School of Medicine. "One of the
barriers to iFR adoption has been the lack of outcome data, however
now we have evidence that an iFR-guided treatment strategy is as
reliable as an FFR-guided strategy with regard to future
cardiovascular events. Additionally, I believe iFR will reduce
patient discomfort. Together the results of these
studies demonstrate large simple trials in clinical practice
can be done, and should remove any barriers to the use of coronary
physiology in interventional procedures."
In image-guided therapies of coronary artery disease, clinicians
have been using FFR in addition to angiographic images to assess
the physiology of a suspected blockage in coronary arteries to
decide, guide, treat and confirm the appropriate therapy. iFR is
the next generation physiologic measurement that uses the same
pressure guide wires and equipment as FFR, but avoids the
administration of hyperemic agents to the patient that is required
with FFR.
The DEFINE FLAIR and iFR Swedeheart trials demonstrate that,
compared to FFR, iFR offers reduced procedure time, cost and
complexity without degradation of major adverse cardiac events
(MACE). The primary endpoint of DEFINE FLAIR and iFR Swedeheart
was MACE rate at one year in iFR and FFR groups. DEFINE FLAIR shows
MACE rates of 6.8 percent in the iFR-guided arm versus 7.0
percent in the FFR-guided arm, p=0.003 for non-inferiority. The
iFR Swedeheart outcome data showed MACE rates of 6.7 percent in
the iFR-guided arm versus 6.1 percent in the FFR-guided arm,
p=0.007 for non-inferiority.
The two trials further established that iFR offers a faster
procedure while almost completely eliminating severe patient
symptoms as compared to FFR. The DEFINE FLAIR study found that
due to eliminating the need for a hyperemic drug, iFR-guided
treatments lead to a 10 percent reduction in procedural time versus
FFR-guided treatment (p=0.001), while reducing patient
discomfort by 90 percent (p<0.01). Side effects of hyperemic
drugs can include increased heart rate, pounding of the heart,
flushing, elevated temperature and feelings of impending doom,
which simulate physical and emotional distress.
"The clinical validation of our innovations is a critical
element of our strategy in image-guided therapy," said Christopher Barys, Business Leader at Philips
Volcano. "The outcomes of these clinical studies underpin the value
of iFR and its benefits for patient safety and effective diagnoses.
It is our hope that the results advance the adoption of iFR to help
physicians improve patient care. This is one of the largest
coronary physiologic datasets ever collected and truly demonstrates
the value of iFR in the physiological assessment of coronary artery
disease in patients."
DEFINE FLAIR was a randomized, blind comparison of clinical
outcomes and cost efficiencies of iFR and FFR interventions of
2,492 patients in 49 centers across Europe, Asia,
North America, and Africa. iFR Swedeheart was a randomized trial
of 2,037 patients in 15 centers in Sweden, Denmark, and Iceland assessing outcomes of iFR versus FFR
guided intervention. Both studies conducted their comparisons of
iFR versus FFR using pressure guide wires and equipment from
Philips. Since the introduction of the hyperemia-free iFR modality
in 2013, iFR has been studied in nearly 15,000 patients and is used
in more than 4,100 catheterization labs across the world.
For more information on Philips and the iFR data, please visit
http://www.philips.com/iFR and follow the #ACC2017
conversation with @PhilipsLiveFrom throughout the event.
For further information, please contact:
Alicia Cafardi
Philips Group Press Office
Tel: +1 412-523-9616
Email: Alicia.Cafardi@philips.com
Kathleen Lozen
Philips Volcano
Tel: +1 617-529-2958
Email: Kathleen.Lozen@philips.com
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' health technology portfolio generated 2016 sales of
EUR 17.4 billion and employs
approximately 71,000 employees with sales and services in more than
100 countries. News about Philips can be found at
www.philips.com/newscenter.
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