Health Economic Data Presented From DEFINE-FLAIR Study of iFR-Guided Revascularization Strategy

March 10, 2018—Royal Philips announced health economic results comparing cost-effectiveness between instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in the guidance of treating ischemic heart disease in the DEFINE-FLAIR clinical trial. DEFINE-FLAIR investigator Rasha Al-Lamee, MD, presented the data at the American College of Cardiology's (ACC) 67th annual scientific session held March 10–12 in Orlando, Florida.

According to Philips, DEFINE-FLAIR is a randomized, controlled, single-blinded comparison of clinical outcomes and cost efficiencies of iFR- and FFR-guided interventions of 2,492 patients in 49 centers across Europe, Asia, North America, and Africa. Patients were randomized 1:1 to iFR-guided (n = 1,242) or FFR- guided (n = 1,250) revascularization. The clinical outcomes from DEFINE-FLAIR were presented in 2017 at ACC's 66th annual scientific session in Washington DC.

The study was supported by unrestricted grants from Philips Volcano to investigate the company's iFR, a pressure-derived index that allows a simplified hyperemia-free physiologic assessment of coronary blockages.

The economic analysis found that an iFR-guided strategy offers a 1-year average cost savings of $896 per patient compared to an FFR-guided strategy while delivering consistent patient outcomes.

With a total procedure cost-savings of approximately 10% per patient versus FFR, iFR-guided procedures also resulted in fewer coronary artery bypass graft procedures and fewer subsequent revascularizations. Previous data from DEFINE-FLAIR released in 2017 found that iFR-guided treatments reduced procedure time by 10% versus FFR-guided treatments and reduced patient discomfort by 90%.

In the company's announcement, study co-chair Manesh Patel, MD, commented, "The findings from DEFINE-FLAIR continue to demonstrate the benefits of iFR, showing that an iFR-guided treatment offers proven outcomes, reduced costs and procedure time, and enhanced patient comfort compared to FFR. iFR is not only a faster diagnostic solution, but it also offers the advantage of significantly reduced patient discomfort. By implementing an iFR program at a hospital, this solution can deliver the clinical outcome benefits of physiology-driven PCI, while reducing annual health care costs significantly across the organization." Dr. Patel is Chief of the Division of Cardiology and Co-Director of the Duke Heart Center at Duke University School of Medicine in Durham, North Carolina.