Philips: results of DEFINE percutaneous coronary intervention study

At the American College of Cardiology’s annual meeting in New Orleans, U.S., Royal Philips announced the results of the DEFINE PCI study, which assessed the level of residual ischemia found in patients after percutaneous coronary interventions. This study found that 1 in 4 patients treated with standard of care PCI left the cath lab with residual ischemia, as demonstrated by using a blinded iFR pullback measurement, which is Philips’ new physiologic guidance technology. Sponsored by Philips, the DEFINE PCI study involved approximately 500 patients, and was led by investigators from the Cardiovascular Research Foundation, Duke Clinical Research Institute and the Imperial College London. The DEFINE PCI study, which took place at centers throughout the U.S. and Europe, shows that the current approach to PCI has limitations for identifying the locations of physiologically significant arterial lesions in patients suffering from coronary artery disease. Of the patients with residual ischemia, the study showed that 81.6% of those patients had an untreated focal stenosis. Further analysis of the study data showed that if all focal stenoses had been identified and successfully treated, only 1 in 20 patients would still have residual ischemia. This indicates that if the precise locations causing ischemia are better detected prior to stenting, patient outcomes may be improved. iFR is well established for determining whether a vessel is indicated for treatment through the landmark DEFINE FLAIR and iFR Swedeheart outcome studies, both published in the New England Journal of Medicine. The one-year patient outcomes were consistent with fractional flow reserve, while iFR involved less procedural time, reduced patient discomfort, and reduced cost. Philips SyncVision iFR Co-registration further advances physiology by mapping the pressure profile of the whole vessel onto the angiogram, providing physiologic guidance for where to treat within the vessel. With iFR Co-registration, physicians can identify the precise locations causing ischemia, plan stent length and placement with a virtual stent, and predict physiologic improvement. Philips SyncVision with iFR Co-registration provides physicians with a full physiologic image allowing them to see clearly and treat optimally.

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