Philips at TCT 2019: New DEFINE iFR trial data; intravascular ultrasound trial kicks off
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Over the weekend, Transcatheter Cardiovascular Therapeutics 2019 (TCT 2019) took place in San Francisco, U.S. Now in its 31st year, TCT is the annual scientific symposium of the Cardiovascular Research Foundation (CRF) and is considered one of the world’s leading educational meetings specializing in interventional cardiovascular medicine. TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.
For Philips, TCT provided an opportunity to present its latest interventional cardiology innovations. As a leader in image-guided therapies, Philips offers turn-key solutions for its customers and their patients comprising interventional imaging systems, advanced diagnostic devices – such as Intravascular Ultrasound (IVUS) catheters and instant wave-free ratio (iFR) and fractional flow reserve (FFR) pressure measurement wires – and specialized treatment devices, planning and navigation software, as well as a broad range of services.
Chris Landon, the general manager of Philips’ Image Guided Therapy Devices business, was in San Francisco for the event. We took the opportunity to catch up with him after the show.
What were your highlights from TCT2019?
Chris Landon: With the significant expansion of our image-guided therapy devices portfolio over the last few years, TCT has become more important for Philips. There is tremendous value in coming together with clinical leaders and industry partners to be inspired by the latest innovations and learn from newly published research in interventional cardiology.
The medical community is always looking for ever more precise, accurate and efficient tools in order to decide, guide, treat and confirm the right therapy for the right patient at the point of care. Since 2014, a combined total of more than 5,000 patients have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions using an iFR pressure measurement technology versus conventional FFR measurements. The iFR index is unique to Philips, allowing a simplified hyperemia-free physiological assessment of blockages in the coronary arteries that feed the heart muscle with oxygen and glucose.
For Philips, the presentation of the two-year data of two of these studies, the DEFINE FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization) trial and the iFR SWEDEHEART trial was therefore an important moment at the symposium. The DEFINE FLAIR results continued to find consistent equivalent outcomes between iFR and FFR in the guidance of treatment of ischemic heart disease. The consistent outcomes between iFR and FFR were further reinforced with the presentation of the two-year results from the iFR SWEDEHEART study, which showed no difference in composite endpoint and mortality and included 100% follow-up.
Also published during the show was the DEFINE LM (Left Main) Registry. This international multi-center registry provides additional reassurance for physicians using iFR for the assessment of the left main coronary artery. Specifically, the registry shows that left main deferral – i.e. a decision not to treat – is safe with iFR. Patient outcomes were similar in both the deferred and revascularized groups, as determined by an iFR cutoff of ≤0.89.
What are the main industry trends at the event?
CL: When you step back and take a view of where healthcare is heading overall, the concept of value-based care is now becoming a reality on the ground, and that’s something we’re also seeing in interventional cardiology. Of course, we’ve always had a strong focus on proving the clinical and economic outcomes of our solutions. The growth of office-based labs and widening range of treatments they provide is a good example of delivering care at a lower cost and bringing treatment closer to the patient.
We’ve always had a strong focus on proving the clinical and economic outcomes of our solutions.
Philips is active on both the devices and systems side of image guided therapy. How is that translating into benefits for clinicians?
CL: By spanning both devices and systems it means we can focus on developing integrated, procedure-oriented solutions for our customers. A great example is our recently-introduced IntraSight interventional applications platform. It’s a secure, application-based platform that combines iFR, FFR, IVUS and co-registration of those modalities with interventional X-ray. Procedures are becoming more complex and demanding for physicians, so by integrating all these different information sources into one platform and making it more intuitive to interact with, we can help to make the interventional lab workflow smart, simple and seamless.
At TCT 2019 the MedStar Cardiovascular Research Network announced that it’s sponsoring a new trial looking at IVUS-Guided PCI of Complex Lesions. What is Philips’ view of this trial?
CL: IVUS helps assess disease, guide treatment decisions and confirm therapy results. The IMPROVE (IMPact on Revascularization Outcomes of intraVascular ultrasound guided treatment of complex lesions and Economic impact) randomized trial will compare IVUS to conventional angiography in the guidance of the treatment of complex lesions. Together with Medtronic, we’re collaborating with MedStar on this study. We’re excited about its potential to assess whether, in a complex PCI patient cohort, use of intravascular imaging may generate superior clinical outcomes compared to angiography alone.
Chris Landon is Senior Vice President and general manager of Philips Image Guided Therapy Devices