|[September 02, 2014]
Two Year Data from FAME 2 Trial Shows Sustained Benefits of FFR-Guided PCI over Medical Treatment in Patients with Stable CAD
ST. PAUL, Minn. & BARCELONA, Spain --(Business Wire)--
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company,
today announced primary outcome two-year data from the FAME 2 Trial
which demonstrated sustained superiority with FFR-guided
PCI using St. Jude Medical PressureWireTM technology in
patients with stable coronary artery disease (CAD) compared to standard
medical therapy alone.
The data were published online in The
New England Journal of Medicine (NEJM) and presented during a
hot line late-breaking session at the European
Society of Cardiology Congress 2014.
The results of FAME 2 show patients with stable CAD who received
FFR-guided PCI (News - Alert) using drug-eluting stents and medical therapy (PCI+MT)
had reduced rates of death, myocardial infarction (MI) or urgent
revascularization compared to patients who received medical therapy (MT)
alone. In particular, in patients who had at least one significant
coronary blockage with an FFR value =0.80, FFR-guided PCI+MT reduced
urgent revascularization by 77 percent compared to medical therapy alone.
"As physicians, we're beginning to understand the challenges of basing
treatment decisions on coronary angiograms that simply do not provide
the full battery of information needed to properly assess lesions
blocking blood flow to the heart," said Dr. Bernard De Bruyne, of the
OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of
the FAME 2 Trial. "The FAME 2 trial demonstrates that for patients with
stable CAD, FFR-guided PCI is the favorable strategy as we look to
improve treatment outcomes, reduce adverse health events and better
assess which lesions require medical intervention."
Specifically, the two year data from FAME 2 shows:
Patients who received FFR-guided PCI+MT had a significantly lower rate
of death, MI or urgent revascularization than patients who received MT
alone (8.1 percent vs. 19.5 percent).
In a landmark analysis, patients who received FFR-guided PCI+MT had a
lower rate of death or MI than patients who received MT alone after
seven days (4.6 percent vs. 8.0 percent).
Patients who received FFR-guided PCI+MT had fewer urgent
revascularizations than patients who received MT alone (4.0 percent
vs. 16.3 percent).
Preliminary results of the FAME
2 trial were originally presented during a hot line session at ESC (News - Alert)
2012 and published in The
New England Journal of Medicine.
"As a sponsor of the FAME 2 Trial, we are excited that our technology
has been shown to provide such profound clinical benefit to patients
living with coronary artery disease," said Dr. Mark Carlson, chief
medical officer at St. Jude Medical. "Our goal in bringing new products
to market is to generate a meaningful clinical impact. The FAME family
of studies continues to demonstrate that our FFR technology provides
meaningful information for physicians, improves patient outcomes, and
reduces costs for health care systems."
Coronary artery disease is the most common form of heart disease and the
leading cause of death for both women and men worldwide. Diagnosis,
management and treatment of this epidemic disease continue to account
for hundreds of billions of dollars in global health care expenditures
annually. Results from the landmark FAME trials have continued to add to
the growing body of evidence demonstrating improved outcomes and cost
savings when FFR-guided therapy is used during coronary interventions.
About FAME 2
The FAME 2 trial began enrolling patients in May 2010 and was designed
to evaluate FFR-guided PCI+MT (with second generation drug-eluting
stents) versus MT alone in patients with stable CAD. The study sought to
assess reductions in death from any cause, a difference in rates of
nonfatal myocardial infarction (MI) or unplanned hospitalization leading
to urgent revascularization over the first two years. FFR was measured
using two St. Jude Medical products, the PressureWire™AerisTM
CertusTM intravascular pressure sensors. Medical therapy
included daily aspirin, a beta blocker alone or in combination with a
calcium channel blocker and/or long-acting nitrate, and medication to
control and lower blood pressure.
Preliminary results revealed that in patients with stable CAD,
FFR-guided PCI relying on St. Jude Medical PressureWireTM yielded
an 87 percent relative risk reduction for unplanned re-admission to the
hospital with urgent revascularization. At the time, analysis suggested
the benefits of PCI+MT may increase over time.
Due to a highly significant between-group difference favoring FFR-guided
PCI+MT, recruitment to the FAME 2 trial was stopped prematurely by the
trial's independent Data Safety Monitoring Board. The Board believed
there was increased patient risk of major adverse cardiac events (MACE)
among patients randomized to medical therapy alone. At the time
enrollment was stopped in January 2012, 1,220 patients with stable CAD
were enrolled at 28 centers across Europe, the U.S. and Canada.
About Fractional Flow Reserve (FFR)
FFR 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 (News - Alert). 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 health care 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 (News - Alert) @SJM_Media.
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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 (News - Alert), including those described in the Risk Factors and
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10-K for the fiscal year ended December 28, 2013 and Quarterly Report on
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