Cost Effectiveness Study Determines FFR Can Improve Health while Reducing Economic Burden in UK, France and Italy
May 20 2011 - 3:40AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that an analysis of the benefits to using
a Fractional Flow Reserve (FFR)-guided intervention strategy found
that the technology can improve patient outcomes while saving
significant amounts of money. Full results for the UK, France and
Italy and preliminary results in Switzerland and Belgium were
announced at a Late Breaking Trial session today at EuroPCR.
The analysis, which was funded by an educational research grant
from St. Jude Medical, found that within each of the country’s
respective health care systems, the FFR-guided approach is
cost-saving, meaning that use of FFR improves health outcomes for
patients with multivessel coronary artery disease at lower costs
when compared to using angiography alone.
The magnitude of health and budget impact strongly depends on
assumptions about the cost of cardiovascular care in each country
and local clinical conditions. Additionally, in each country the
use of the PressureWire™ technology improved the quality-adjusted
life expectancy for PCI patients.
“In each region where this economic analysis was conducted, the
PressureWire was found to both improve clinical outcomes by
increasing quality-adjusted life years and reducing the number of
cardiac events and save a substantial amount of resources,” said
Professor Uwe Siebert, M.D., M.Sc., M.P.H., Sc.D., from the Health
and Life Sciences University of Hall (Austria), who led the
research project. “Our research reveals that the magnitude of the
health benefits and cost savings from FFR measurement for the
European patients and health care payers could be even more
significant under an optimal FFR implementation scenario.”
Specifically, in the context of the current healthcare model for
each respective country, the analysis found:
In the United Kingdom FFR use:
- Can prevent on average more than 30
avoidable deaths, more than 70 heart attacks and more than 120
major adverse cardiac events (MACE) over two years
- Could save the British healthcare
system more than 300,000£ in 2011 and more than 800,000£ in
2012
- Potentially reduces treatment cost for
PCI per patient by an average of about 600£ in the UK
In France FFR use:
- Can prevent on average nearly 300
avoidable deaths, nearly 700 heart attacks and about 1,200 MACE in
France over two years
- Could save the French healthcare system
more than 5 million€ in 2011 and more than 11 million€ in 2012
- Potentially reduces treatment cost for
PCI per patient by an average of about 900€ in France
In Italy FFR use:
- Can prevent on average more than 120
avoidable deaths, more than 300 heart attacks and more than 520
MACE in Italy over two years
- Could save the Italian healthcare
system more than 800,000€ in 2011 and more than 3 million€ in
2012
- Potentially reduces treatment cost for
PCI per patient by an average of about 500€ in Italy
The study was conducted to determine the incremental
cost-effectiveness of FFR-guided vs. angiography-guided PCI in
patients with multivessel coronary artery disease in the various
health care systems in question from the societal perspective. To
do this, original patient-level data from the landmark FAME
(Fractional Flow Reserve (FFR) vs.
Angiography in Multivessel Evaluation) study were used.
“Results in both the U.S. and now in Europe have demonstrated
that FFR both improves patient outcomes and reduces cost to the
healthcare system. With healthcare system finances under pressure
everywhere, we are proud to offer a technology that relieves
European health care systems from financial pressure and that
protects and saves the lives of European patients,” said Frank J.
Callaghan, president of the St. Jude Medical Cardiovascular
Division.
The methodology of the data analysis in each country was
verified by local physicians.
Preliminary results in Belgium and Switzerland also reveal a
trend towards cost-savings. The full report for these countries
will be revealed later this year.
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 patient’s ischemia, a deficiency of blood supply
to the heart caused by blood restriction. The benefits of FFR were
recognized in the European Society of Cardiology (ESC) and the
European Association for Cardio-Thoracic Surgery (EACTS) Guidelines
with new recommendations for the treatment of coronary artery
disease which support measuring FFR in a wide range of patients
before performing PCI or recommending surgery.
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 Medical’s PressureWire Certus
technology exclusively for FFR measurement. 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), including death, myocardial
infarction (heart attack) or repeat revascularization, were reduced
by 28% 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% 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.
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 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2011. 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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