St. Jude Medical, Inc. (NYSE:STJ) applauds the updated level of evidence
for Fractional Flow Reserve (FFR)-guided treatment in the Guidelines on
Percutaneous Coronary Intervention (PCI). The American College of
Cardiology (ACC)/American Heart Association (AHA)/Society for
Cardiovascular Angiography and Interventions (SCAI) guidelines upgrade
the level of evidence for FFR, a physiological measure of coronary
stenosis, from a “B” to an “A” because of new research conducted to
determine its efficacy; the landmark FAME (Fractional
Flow Reserve (FFR) vs. Angiography
in Multivessel Evaluation)
trial demonstrated improved outcomes for patients with multivessel
coronary artery disease whose treatment was guided by St. Jude Medical
FFR Measurement Systems rather than by standard angiography alone.
The ACC/AHA/SCAI guidelines, which are intended to assist healthcare
providers in clinical decision making, now classify FFR as “Class IIa
with level of evidence A.” Level of evidence “A” is the highest level
available, requiring the most clinical evidence, and is awarded only
when data is derived from multiple populations and multiple randomized
clinical trials or meta-analyses. The updated recommendation for FFR was
issued in response to the important FAME trial data, which demonstrated
many patient benefits, including a 34% reduced risk of combined death or
myocardial infarction (heart attack) for those whose treatment was
guided by St. Jude Medical’s PressureWire Certus™ technology prior to
coronary stenting rather than angiography alone.
Because data show that having physiological lesion assessment available
prior to placement of coronary stents helps physicians better determine
which specific lesion or lesions are responsible for a patient’s
ischemia, a deficiency of blood supply to the heart caused by blood
restriction, the guidelines suggest that FFR can be useful to optimize
clinical outcomes. The recommendations supported by a level of evidence
“A” state that FFR can be useful in assessing whether an intervention in
a coronary lesion(s) is necessary, as an alternative to noninvasive
functional testing, and to help assess intermediate stenosis in patients
with anginal symptoms.
“St. Jude Medical is dedicated to providing physicians with technologies
that aid them in making the best treatment decisions for their
patients,” said Frank J. Callaghan, president of the St. Jude Medical
Cardiovascular Division. “The higher level of evidence confirms what we
have already known about FFR, that it is a technology that benefits
patients, improves clinical outcomes and reduces the overall cost of
treatment.”