February 11, 2020
Philips’ DEFINE GPS Trial Will Assess Outcomes of PCI Guided by an Integrated Platform of iFR and Angiogram
February 11, 2020—Royal Philips announced a new randomized controlled trial to assess patient outcomes after receiving percutaneous coronary intervention (PCI) guided by Philips’ coregistration platform (which combines data of instant wave-free ratio (iFR) measurement and angiography) compared with the standard of care treatment guided by angiography alone.
The DEFINE GPS study will involve iFR in conjunction with the company’s SyncVision, an image-guided coregistration system, to evaluate PCI guidance and the optimization of treatment outcomes. The trial is expected to enroll up to 3,000 patients at 75 sites. The first patients will be recruited in the second half of 2020.
The global, multicenter, prospective, randomized controlled DEFINE GPS study will investigate the impact of iFR coregistration on outcomes and cost-effectiveness. The primary endpoint is target vessel failure (a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization) or rehospitalization for progressive or unstable ischemia at 2 years.
The DEFINE GPS study is sponsored by Philips, with the Cardiovascular Research Foundation in New York, New York, overseeing core lab and clinical event committee activities.
Allen Jeremias, MD, with St. Francis Hospital in Roslyn, New York, is Principal Investigator of the DEFINE GPS study. Dr. Jeremias commented in the company’s announcement, “PCI has made a major positive impact on many coronary artery disease patients’ lives. However, 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 1 year after receiving treatment.”
He continued, “With the DEFINE PCI study, we observed that the current approach to PCI has limitations for identifying the locations of physiologically significant arterial lesions. 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.”
Gregg W. Stone, MD, Chairman of the DEFINE GPS trial, stated, “As coronary stenting is applied to increasingly complex patients, it is essential that we ensure that all segments of coronary artery disease that need treatment are treated, a process that we believe can be facilitated by iFR assessment of the entire coronary artery, coregistered to the angiogram. We are thrilled to be able to examine the extent to which this technique improves patient outcomes in the large-scale DEFINE GPS trial.” Dr. Stone is Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai in New York, New York.