A study, sponsored by St. Jude Medical, will assess the costs and outcomes linked to fractional flow reserve (FFR) interventional strategies for coronary artery disease patients in seven regions.
According to the company, the data will be based on the results of its FAME ( Fractional Flow Reserve vs. Angiography in Multivessel Evaluation) trial and will outline the health and cost impacts of FFR strategies in Belgium, Canada, France, Germany, Italy, Switzerland and the U.K.
The study will evaluate cost savings from FFR strategies during PCI, savings for the healthcare system and patient outcomes, the company said.
During the FAME trial, 1,005 patients with CAD were enrolled and received either FFR treatment with the PressureWire Aeris or PressureWire Certus or standard PCI. Results showed that patients undergoing FFR saw a 34 percent decline in mortality and MI and also a cost savings of 14 percent.
The study will be investigated by Uwe Siebert, MD, PhD, in addition to a local clinical advisor from each country to validate the data.