DEFINE PCI study one-year data show potential of treating residual ischemia to improve clinical outcomes for coronary stent p...
October 15 2020 - 1:00PM
October 15, 2020
New data suggest that PCI guided by iFR co-registered on the
angiogram can improve outcomes and reduce angina for patients more
effectively than treatment guided by angiography alone
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG,
AEX: PHIA), a global leader in health technology, today announced
the one-year results of the DEFINE PCI [1] study at the Cardiology
Research Foundation’s TCT Connect 2020 virtual conference. The
DEFINE PCI study assessed the level of residual ischemia, or
reduced blood flow to the heart muscle, found in patients after a
percutaneous coronary intervention (PCI), an image-guided,
minimally invasive treatment to open coronary artery blockages. The
assessment was carried out using a blinded instant wave-Free Ratio
(iFR) pullback measurement, a physiologic guidance technology
unique to Philips.
The exciting promise of this data is that by using iFR
co-registration physicians can identify precise locations causing
ischemia, plan stent length and even place a virtual stent to
predict physiologic improvement before the intervention is
performed. The blinded acute data of DEFINE PCI revealed that 24%
of patients with angiographically successful PCI still had residual
ischemia. In approximately 82% of these patients, the residual
ischemia was the result of a focal, potentially treatable lesion.
The data suggests patients could have benefited from planning tools
like iFR co-registration to find potentially treatable lesions that
are often not identified by angiography alone.
The DEFINE PCI one-year data release shows that patients whose
baseline ischemia was more effectively treated (post-PCI iFR ≥0.95)
had improved outcomes and less recurrent angina (chest pain) at one
year. The one-year data showed an optimal post-PCI iFR of ≥0.95 was
associated with improved event-free survival. In fact, patients
with a post-PCI iFR of ≥0.95 had 68% fewer clinical events than
patients with less than optimal post-PCI iFR values (1.8% vs 5.7%,
p=0.04).
“In DEFINE PCI we noted that if all lesions causing focal
ischemia had been treated up-front, the rate of significant
ischemia could theoretically be reduced from 24% to 5%,” said Allen
Jeremias MD, principal investigator of the DEFINE PCI study. “Now
with the one-year data, we find that patients with more complete
resolution of ischemia do better clinically. To some that may not
be a surprising finding, but we are conducting the science because,
today, most interventionalists are only using physiology as a
“who-to-treat” tool. Beyond who we should treat, tools like iFR can
guide “how” and “where” to treat within a vessel and then confirm
results after stent placement. It’s difficult to know which lesions
will produce a significant physiological gradient and which won’t.
If you don’t measure, really there’s no way of telling.”
“The goal is to get patients as close to normal,
physiologically, as possible,” said Manesh Patel, MD, co-author of
the DEFINE PCI study. “We’ve known this for a while, but we haven’t
had the mature technology to deliver on this. We now have
technology such as iFR co-registration to determine the
risk-benefit of revascularization as well as when, how, and where
we should treat – and that should lead to better outcomes for
patients.”
The DEFINE PCI one-year data release follows the 500 patients
who participated in the DEFINE PCI study announced last year at the
American College of Cardiology (ACC) annual conference. The initial
study results showed that 1 in 4 patients treated with standard of
care PCI left the cath lab with residual ischemia (iFR < 0.90)
[1].
“The one-year data from DEFINE PCI are the latest evidence that
iFR contributes to reduced costs, enhanced patient experience and
improved outcomes for PCI procedures [2, 3, 4],” said Chris Landon,
Senior Vice President and General Manager Image Guided Therapy
Devices at Philips. “With the recent introduction of OmniWire, the
world’s first solid core pressure guide wire for coronary artery
interventional procedures, as well as the next generation of our
Azurion platform, we are advancing image-guided therapy with
innovative, procedure-focused solutions.”
DEFINE GPS: evaluating whether iFR co-registration guidance
improves patient outcomes in a large, prospective, randomized
trialIn February, Philips announced DEFINE GPS, a randomized,
controlled prospective trial which represents the next step in the
DEFINE series of physiology studies. DEFINE GPS will assess the
clinical effectiveness of iFR co-registration guidance to minimize
post-PCI ischemia in patients. The study, which will include up to
3,000 participants at approximately 100 sites globally, will help
determine whether a physiology-based PCI approach results in
superior patient outcomes compared to standard angioplasty.
Enrolment is expected to begin in Q1 2021.
The DEFINE PCI and DEFINE GPS studies are 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] Manesh R. Patel. Cost-effectiveness of iFR
compared with FFR to guide coronary revascularization
decision-making-Analysis from DEFINE FLAIR. The American College of
Cardiology (ACC) annual meeting in Orlando, Florida, March 10–12,
2018.
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 81,000
employees with sales and services in more than 100 countries. News
about Philips can be found at www.philips.com/newscenter.
- iFR data co-registered on the angiogram
- iFR co-registered on the angiogram
- Philips OmniWire 3D view
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