Philips is launching a new randomized controlled trial—dubbed DEFINE GPS—to assess patient outcomes after PCI guided by instant wave-Free Ratio (iFR) measurements and angiograms.
DEFINE GPS (Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting) will enroll up to 3,000 participants at up to 75 different sites, according to a statement from Philips. The study will compare outcomes between patients who undergo PCI using Philips’ iFR and angiogram platform and those who undergo PCI guided by angiogram alone.
European and U.S. guidelines already endorse the use of coronary physiologic measurements with iFR and fractional flow reserve to determine the significance of a narrowed coronary artery, Philips said, but DEFINE GPS will be the first time the use of iFR and Philips’ Image-Guided Co-Registration System (SyncVision) will be evaluated together.
“PCI has made a major positive impact on many coronary artery disease patients’ lives,” Allen Jeremias, MD, of the Cardiovascular Research Foundation in New York, said in the release. Jeremias has been named principal investigator for DEFINE GPS. “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 DEFINE GPS we will be able to determine if a physiology-based PCI approach results in superior patient outcomes when compared with standard angioplasty.”
The global, prospective RCT will reportedly investigate the impact of iFR Co-Registration on both patient outcomes and cost-effectiveness. The primary endpoint will be target vessel failure 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 and enhancing the patient experience,” Chris Landon, senior vice president and general manager of image-guided therapy devices at Philips, said. “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.”