ST. PAUL, Minn.–(BUSINESS
WIRE)–St. Jude Medical, Inc., a global medical device company,
today announced that an analysis of the benefits of using a Fractional Flow
Reserve (FFR)-guided intervention in Belgium to determine the severity of blood
flow blockages in patients coronary arteries can improve patient outcomes
while saving millions of Euros.
The analysis, which was funded by an educational research
grant from St. Jude Medical, found that within the Belgian health care system,
the FFR-guided approach is cost-saving, meaning that use of FFR technology
improves health outcomes for patients with multivessel coronary artery disease
at lower costs when compared to using angiography alone.
In the context of the current Belgian health care model, use
of the PressureWire™ technology to measure FFR:
- Can prevent, on average, more than 60 avoidable deaths, more
than 140 heart attacks and more than 245 major adverse cardiac events (MACE) in
Belgium
over two years - Could save the Belgian health care system nearly 4 million€
over two years - Potentially reduces treatment cost by an average of 950€ per
patient in Belgium
for Percutaneous Coronary Intervention (PCI), also known as coronary
angioplasty - Improves quality-adjusted life expectancy for Belgian PCI
patients
“It is rare in cardiology to find that a new technology not
only prevents heart attacks and saves lives, but also substantially saves
resources,” said Prof. Uwe Siebert, M.D., MSc, M.P.H., ScD. “Though the
FFR-guided strategy was determined to be cost saving in more than 99 percent of
the results, the magnitude of the health benefits and cost savings from FFR
measurement will depend on the willingness to make the use of the PressureWire
technology the standard of care for patients with multivessel coronary
disease.”
The study was designed to determine the incremental
cost-effectiveness of FFR-guided vs. angiography-guided PCI in patients with
multivessel coronary artery disease in the context of Belgian health care
system from the societal perspective. To conduct the analysis, original data
from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel
Evaluation) study was used. Results from the economic evaluation are based
solely on the use of the St. Jude Medicals PressureWire™ Certus, a FFR measurement
technology.
Previous analysis of the impact of FFR-guided treatment in Germany, France,
Italy and the U.S. also
revealed that use of the PressureWire technology can improve patient health
while significantly saving money in the context of the current health care
model for each respective country.
“Results in every country where an analysis has been
conducted have demonstrated that FFR-guided therapy both improves patient
outcomes and reduces cost to the health care system. With the PressureWire and
other patient-benefitting technologies, St. Jude Medical is proud to help lead
the way in improving the quality of life for patients and helping reduce the
cost of health care in Belgium,”
said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular
Division.
The detailed economic analysis for Belgium was
conducted by Prof. Uwe Siebert. The validity of the Belgian data modeling used
for the analysis was verified by Dr. Bernard De Bruyne, Cardiovascular Center
Aalst, OLV-Clinic-Aalst and Prof. Dr. Walter Desmet, University Hospitals
Leuven.
FFR measurements indicate the severity of blood flow
blockages in the coronary arteries. Using the PressureWire™ Aeris or
PressureWire™ Certus, this physiological measurement helps physicians to better
identify which specific lesion or lesions are responsible for a patients
ischemia, a deficiency of blood supply to the heart. The benefits of the
PressureWire technology were recognized recently in the ESC/EACTS Guidelines
with new recommendations for the treatment of coronary artery disease that
support measuring FFR before deciding to perform PCI or send the patient to
surgery in a wide range of patients.
About the FAME Trial
The FAME study is a randomized, prospective, multi-center trial which enrolled 1,005
patients with multivessel coronary artery disease. The FAME study compared
outcomes for patients whose treatment was guided by FFR to those whose
treatment was guided only by angiography using St. Jude Medicals PressureWire
Certus technology exclusively for FFR measurement. The 12-month results,
published in the Jan. 15, 2009 issue of the New England Journal of Medicine,
demonstrated that instances of major adverse cardiovascular events (MACE),
including death, heart attack or repeat revascularization, were reduced by 28
percent for patients whose treatment was guided by FFR rather than by standard
angiography alone.
Two-year results presented as a late-breaking trial during
the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference demonstrated
that patients who received FFR-guided treatment continued to experience
improved outcomes over time, including a 34 percent risk reduction in death or
heart attack.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting
more control into the hands of those who treat cardiac, neurological and
chronic pain patients worldwide. The company is dedicated to advancing the
practice of medicine by reducing risk wherever possible and contributing to
successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn.
and has four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information, please
visit sjm.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
