New 2010 ESC Guidelines for Percutaneous Coronary Interventions Reinforce Importance of FFR in Treatment of Coronary Artery Disease
FFR is updated to Class 1, level
of evidence A, the highest class and level possible;
Update was driven by the positive results of the landmark FAME trial
|
|
August 31, 2010 -- St. Paul, Minneapolis --
St. Jude Medical, Inc. (NYSE:STJ) applauds the updated class and
level
of evidence for Fractional Flow Reserve (FFR)-guided treatment in
the
Guidelines on Percutaneous Coronary Intervention (PCI) announced Monday
at the European Society of Cardiology (ESC) congress in Stockholm.
Supporting this change are the very strong one and two year data
from
the landmark FAME (Fractional Flow
Reserve (FFR) vs. Angiography in Multivessel
Evaluation) trial, which
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 ESC guidelines, which are intended to assist health
care providers in clinical decision making, now classify FFR-guided treatment
as "Class
I, 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 has been derived from multiple randomized clinical trials or
meta-analyses. Class I indicates a general agreement that a given
treatment or procedure is beneficial, useful, and effective.
Stefan James, M.D., associate professor of cardiology
at Uppsala University Hospital in Uppsala, Sweden, and a member of the ESC
Guidelines task force for myocardial revascularization, commented on the
update, stating, "The overall aim of the new guidelines for both
percutaneous and surgical revascularization has been to shift emphasis
from using primarily the anatomical expression of coronary artery
disease to guide treatment toward a more patient oriented perspective,
where all aspects of the disease are taken into account. In this
context, the physiological impact of coronary lesions and
FFR-measurements play a central role."
Current data show that physiological assessment using FFR prior to
placement of coronary stents helps physicians better optimize clinical
outcomes by determining 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 recommendations supported by a level of
evidence A state that FFR measurements can be useful in assessing
whether an intervention in a coronary lesion is necessary, as an
alternative to noninvasive functional testing, and to help assess
intermediate stenosis in patients with anginal symptoms.
"Given the long-term investments St. Jude Medical continues to make in
lesion assessment technology, including FFR, we are pleased to see the
updated guidelines for this significant technology," said Frank J.
Callaghan, president of the St. Jude Medical Cardiovascular Division.
"This announcement reinforces the value of FFR as a technology that
benefits patients, improves clinical outcomes and reduces the overall
cost of treatment."
The FAME study was a randomized, prospective, multi-center trial which
enrolled 1,005 patients with multivessel coronary artery disease. It
compared outcomes for patients whose treatment was guided by FFR to
those whose treatment was guided only by angiography. The 12-month
results, published in the January 15, 2009 issue of the New England
Journal of Medicine, demonstrated that instances of major adverse
cardiovascular events (MACE), such as death, myocardial infarction or
repeat revascularization, were reduced by 30 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 of
death or myocardial infarction (heart attack). FFR-guided treatment was
also demonstrated to be cost-saving, with a difference of about $2,000,
or 14 percent, between total healthcare costs for the FFR-guided cohort
and the group treated by angiography alone. These lower healthcare costs
were a result of reduced procedural costs, reduced follow-up costs for
major adverse cardiac events and shorter hospital stays.
St. Jude Medical's FFR Measurement System portfolio includes both the
PressureWire Certus and the PressureWire Aeris(TM). The PressureWire Certus
was the only FFR Measurement System used in the FAME trial; the
PressureWire Aeris is the industry's only wireless technology available,
which requires no additional equipment or cabling in the cardiac
catheterization laboratory.
About Fractional Flow Reserve (FFR)
Fractional Flow Reserve (FFR) is an index determining the functional
severity of narrowings in the coronary arteries as measured by
PressureWire Certus and PressureWire Aeris. FFR specifically identifies
which coronary narrowings are responsible for significantly obstructing
the flow of blood to a patients' heart muscle (called ischemia), and it
is used by the interventional cardiologist to direct coronary
interventions and assess results for improved treatment outcomes.
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.
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 Quarterly Report on Form
10-Q for the fiscal quarter ended April 3, 2010. The Company does not
intend to update these statements and undertakes no duty to any person
to provide any such update under any circumstance.
Source: St. Jude Medical, Inc.
|