Five Year Data from the FAME Trial Further Confirms the Sustained, Long Term Benefit of FFR-Guided PCI over Angiography-Guide...
August 30 2015 - 10:34AM
Business Wire
Data presented at the ESC Congress 2015 contributes to the
growing body of long term clinical evidence supporting St. Jude
Medical PressureWire Fractional Flow Reserve technology
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that five year results from the landmark
FAME trial (Fractional Flow Reserve vs. Angiography in Multivessel
Evaluation) have confirmed the long term benefits of fractional
flow reserve (FFR) in guiding percutaneous coronary intervention
(PCI) over angiography alone. An analysis of the study’s five year
follow up data confirms that in patients with multi-vessel coronary
artery disease, FFR-guided PCI can contribute to reductions in
all-cause mortality, cardiac mortality and an overall use of health
care resources.
The data, which were presented at the ESC Congress 2015, build
upon previously-published results from the St. Jude Medical
sponsored FAME trial at 12-months and two-year follow up
intervals.
“Original 12 month results from the FAME trial and the study’s
two year follow-up data demonstrated clearly that PCI guided by
fractional flow reserve results in a significant reduction in major
adverse cardiac events for patients undergoing PCI,” said the FAME
study’s principal investigator, Nico H.J.Pijls, M.D., Ph.D., of
Catharina Hospital in Eindhoven, The Netherlands. “Now, the study’s
five year follow up data have given us a critical look at the
impact of FFR guidance over time. We’ve proven that the benefits
are sustained and can dramatically impact the long-term wellbeing
and clinical outcomes of patients as compared to only using
angiography to guide intervention.
After five years of patient follow up, FAME researchers have
found that FFR guidance using St. Jude Medical PressureWire™
technology can lead to a more favorable treatment and clinical
decision making, which can result in fewer events in the first two
years and a sustained benefit up to five years. In addition, five
year follow up data from the FAME trial demonstrate:
- Improved patient outcomes. In
patients with multi-vessel coronary artery disease, FFR-guided PCI
resulted in a 27 percent relative reduction of cardiac mortality
versus angiography alone.
- An overall decline in adverse
events. Adverse events among patients who received FFR-guided
PCI consistently decreased compared to patients who received
angiography-guided PCI.
- FFR’s positive economic impact on
health care cost. Five year data from the FAME trial further
supports the positive economic impact and reduction of health care
resource utilization shown by the original results of the
study.
“The five year data from the FAME study build upon our
understanding of applying FFR to guide the care of patients
battling coronary artery disease, and this study has continued to
demonstrate that St. Jude Medical’s PressureWire technology can
improve patient outcomes and the clinical benefits of PCI, while
reducing costs for the health care system,” said Mark Carlson,
M.D., chief medical officer at St. Jude Medical. “FFR technology
provides physicians with the insight they need to make improved
clinical decisions for their patients.”
Coronary artery disease is the most common form of heart disease
and the leading cause of death for both men and women worldwide.
The condition is caused by plaque build-up in the arteries, which
can narrow blood vessels and block blood flow to the heart. During
PCI procedures, FFR is used to provide physicians with a detailed
analysis of the blood flow blockage to make decisions on how to
best keep the artery expanded to restore blood flow to the heart
and to determine whether coronary intervention – such as stenting,
is necessary.
About the FAME Trial
The original FAME (Fractional Flow Reserve (FFR) vs. Angiography
in Multivessel Evaluation) Trial compared outcomes of patients
whose treatment was guided by FFR to those whose treatment was only
guided by angiography. Results from the landmark trial demonstrated
improved clinical outcomes in patients with stable coronary artery
disease and two or three vessel disease.
The 12 month results published in the New England Journal
of Medicine demonstrated that instances of major adverse
cardiac events were reduced by 28 percent for patients whose
treatment was guided by FFR rather than by standard angiography
alone. Two year results 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 Fractional Flow Reserve
Fractional flow reserve is a physiological index used to
determine the hemodynamic severity of narrowings (or lesions) in
the coronary arteries, and is measured using St. Jude Medical
PressureWire™ Aeris™ and PressureWire™ Certus™ FFR measurement
system. FFR specifically identifies which coronary narrowings are
responsible for obstructing the flow of blood to a patient’s heart
muscle (called ischemia), and helps guide the interventional
cardiologist in determining which lesions warrant stenting,
resulting in improved patient outcomes and reduced healthcare
costs.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer
dedicated to transforming the treatment of some of the world’s most
expensive epidemic diseases. The company does this by developing
cost-effective medical technologies that save and improve lives of
patients around the world. Headquartered in St. Paul,
Minn., St. Jude Medical has four major clinical focus
areas that include cardiac rhythm management, atrial fibrillation,
cardiovascular and neuromodulation. For more information, please
visit sjm.com or follow us on
Twitter @SJM_Media.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made
by the Company are based upon management’s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control
and the risk factors and other cautionary statements described in
the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the
Company’s Annual Report on Form 10-K for the fiscal year ended
January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 4, 2015. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
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version on businesswire.com: http://www.businesswire.com/news/home/20150830005036/en/
St. Jude Medical, Inc.Investor Relations:J.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia RelationsMatt Puplett,
651-756-6293mpuplett@sjm.com
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