Royal Philips Commences DEFINE GPS Study

June 22, 2021—Royal Philips announced the commencement of the DEFINE GPS study with the first patient enrolled by Allen Jeremias, MD, at St. Francis Hospital in Roslyn, New York.

Dr. Jeremias serves as principal investigator of DEFINE GPS. Gregg W. Stone, MD, who is the Director of Academic Affairs for the Mount Sinai Heart Health System in New York, New York, is Chairman of the DEFINE GPS study.

According to the company, the global, multicenter, prospective, randomized controlled trial will investigate if guidance by instantaneous wave-free ratio (iFR) measurements coregistered on the angiogram demonstrates superior outcomes and improves the cost-effectiveness of percutaneous coronary intervention (PCI) procedures.

DEFINE GPS (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting) will evaluate the use of iFR measurements in combination with Philips’ SyncVision, an image-guided coregistration system to enhance PCI guidance and provide superior treatment outcomes.

Using an adaptive study design, DEFINE GPS will include up to 3,200 participants across 100 sites worldwide. It will be one of the largest studies ever sponsored by Philips, noted the company. The Cardiovascular Research Foundation is overseeing core lab and clinical event committee activities.

Philips noted that DEFINE GPS is a follow-up to the DEFINE PCI study, a 1-year trial sponsored by Philips that evaluated the potential of treating residual ischemia to improve clinical outcomes for coronary stent patients. Philips announced the 1-year results of the DEFINE PCI study in October 2020 when they were presented at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation.

“The DEFINE GPS trial, designed to explore the promising hypotheses that emerged from DEFINE PCI, is a landmark trial that heralds the promise of post-PCI physiologic assessment,” commented Dr. Stone in the company’s press release. “While the benefits of physiology prior to PCI are unquestioned, this large-scale trial will definitively demonstrate whether after an angiographically successful PCI procedure the identification and treatment of unsuspected residual ischemia by routine iFR assessment can further improve patient event-free survival.”

Dr. Jeremias added, “Conducting rigorous clinical science is how we advance patient care, and, like the seminal FAME study that was carried out over 10 years ago, I believe DEFINE GPS has the potential to change the current standard of care in PCI. PCI has made a major positive impact on many coronary artery disease patients’ lives, but when we look back at all the major, high-quality stent trials over the past 20 years we see that around 20% to 30% of patients continue to have recurring chest pain at one year after receiving treatment. With DEFINE GPS we will be able to definitively determine if a physiology-based PCI approach results in superior patient outcomes compared to standard angioplasty.”