"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 trial
In 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.
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.
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