FAMOUS-NSTEMI Data Support St. Jude Medical's FFR Technology to Guide PCI Treatment

September 1, 2014—St. Jude Medical, Inc. announced that the new multicenter FAMOUS-NSTEMI clinical trial has found that using the company’s fractional flow reserve (FFR) technology changed the course of percutaneous coronary intervention (PCI) treatment for more than one-fifth of patients experiencing non-ST segment elevation myocardial infarction (NSTEMI). The data also demonstrated that FFR-guided PCI is safe and tended to reduce procedure-related myocardial infarctions in NSTEMI patients over angiography alone. The FAMOUS-NSTEMI trial is the first comprehensive clinical assessment of the ability of PressureWire FFR technology to guide treatment in patients with NSTEMI, noted the company.

The data were presented during a late-breaking session at the European Society of Cardiology’s ESC Congress 2014 in Barcelona, Spain. The British Heart Foundation’s FAMOUS-NSTEMI randomized trial was also published by Jamie Layland, MD, et al online in the European Heart Journal.

The FAMOUS-NSTEMI trial enrolled 350 patients in six hospitals in the United Kingdom between October 2011 and May 2013. Patients enrolled had at least one coronary stenosis at least 30% occluded at time of admission for NSTEMI. In patients randomized to the FFR-guided group, an FFR of > 0.8 indicated revascularization by PCI or coronary bypass surgery.

According to St. Jude Medical, the FAMOUS-NSTEMI study demonstrated that the company’s PressureWire FFR measurement technology altered the treatment strategy for approximately 22% of patients. The study also demonstrated a trend toward a reduction in procedure-related myocardial infarction among patients whose therapy was guided by FFR using the PressureWire technology.

Colin Berry, MD, served as principal investigator of the FAMOUS-NSTEMI clinical trial. In St. Jude Medical’s press release, Dr. Berry commented, “In patients suffering NSTEMI, traditional diagnostic imaging tools have limited our ability to optimally assess which blockages require revascularization. What we’ve now found is FFR 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.” Dr. Berry is Professor of Cardiology and Imaging at the University of Glasgow in Glasgow, Scotland.

St. Jude Medical noted that physicians currently treating NSTEMI patients at a high risk for serious cardiac complications will often opt for a treatment strategy that relies on coronary angiography to assess blood flow within the arteries of the heart. FFR represents a new approach to managing NSTEMI patients because it relies less on subjective visual assessments of angiography and instead offers an objective physiological assessment of blood flow blockages.

According to the company, 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. 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, and repeat revascularization. Preliminary data from FAME 2 further supported FFR and found FFR-guided PCI with PressureWire measurement technology is a cost-effective strategy that can improve clinical outcomes and quality of life in patients with stable coronary artery disease over medical therapy alone.

In January 2009, the FAME results were published in The New England Journal of Medicine (2009;360:213­–224). In September 2012, FAME 2 results were published in The New England Journal of Medicine (2012; 367:991–1001).