St. Jude Medical, a global medical device company, announced a new multi-center clinical trial has found that using St. Jude Medical Fractional Flow Reserve (FFR) technology changed the course of treatment for more than one fifth of patients suffering non-ST segment elevation myocardial infarction (NSTEMI) heart attacks.
The data also demonstrated that FFR-guided PCI is safe and tended to reduce procedure-related myocardial infarctions in NSTEMI patients over angiography alone. NSTEMI is the most common form of acute coronary syndrome and a leading cause of premature morbidity and mortality worldwide.
The data were presented during a hot line late-breaking session at the European Society of Cardiology Congress 2014 and appears in the online version of the European Heart Journal.
"In patients suffering NSTEMI, traditional diagnostic imaging tools have limited our ability to optimally assess which blockages require revascularization," said Dr. Colin Berry, a Professor of Cardiology and Imaging at the University of Glasgow and Principal Investigator of the FAMOUS-NSTEMI clinical trial. "What we’ve now found is fractional flow reserve technology has additive diagnostic and clinical benefits for NSTEMI patients. We need to continue to evaluate the technology’s potential in new segments of patients."
The FAMOUS-NSTEMI trial enrolled 350 patients in six UK hospitals between October 2011 and May 2013. Patients enrolled had at least one coronary stenosis at least 30 percent occluded at time of admission for NSTEMI. In patients randomized to the FFR-guided group, an FFR of greater than 0.80 indicated revascularization by PCI or coronary bypass surgery.
The FAMOUS-NSTEMI study builds on data from the FAME and FAME 2 clinical trials, which support FFR as the standard of care for the treatment of patients with coronary artery disease (CAD).
The original FAME trial, which concluded in 2008, found FFR allows for more accurate identification of narrowed passages most likely to cause a coronary event, reducing rates of death, myocardial infarction (heart attack) and repeat revascularization.
Preliminary data from FAME 2 further supported FFR, and found FFR-guided PCI with PressureWireTM measurement technology is a cost-effective strategy that can improve clinical outcomes and quality of life in patients with stable coronary artery disease (CAD) over medical therapy alone. Results of both the FAME and FAME 2 trials were published in The New England Journal of Medicine.