FAME II Trial Demonstrates FFR-Guided PCI Superior to Medical Treatment in Preliminary Findings
St. Jude Medical PressureWire helped reduce the risk of urgent revascularization by more than eleven times in patients with stable coronary artery disease compared to medical treatment alone
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Dr. Bernard De Bruyne |
May 15, 2012 -- St. Paul, Minn and Paris -- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced that data from the FAME II trial demonstrated a
significant difference in the need for urgent revascularization when
Fractional Flow Reserve (FFR)-guided assessment was used to direct
treatment in patients with stable coronary artery disease. These highly
statistically significant results validate the profound role that
FFR-guided therapy has in improving patient outcomes. The preliminary
data were presented at a late breaking trial session at EuroPCR.
The FAME II (Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary
Intervention Plus Optimal Medical Treatment vs. Optimal Medical
Treatment Alone in Patients with Stable Coronary Artery Disease) trial
began enrolling patients in
May 2010
with the goal of further studying
the role of FFR in the treatment of stable coronary artery disease in
one or more vessels. The trial compared clinical outcomes, safety and
cost effectiveness of percutaneous coronary intervention (PCI) guided by
FFR plus optimal medical treatment (OMT) to OMT alone in patient with
stable coronary artery disease.
Earlier this year,
St. Jude Medical
announced that it was stopping
enrollment in the FAME II trial after an Independent Data Safety
Monitoring Board (DSMB) deemed it unethical to continue to randomize
patients into the arm of the trial receiving optimal medical treatment
alone. The DSMB found a highly statistically significant reduction in
the need for unplanned hospital readmission and urgent revascularization
when FFR-guided assessment was used to direct treatment in patients with
coronary artery disease. The data presented today provided background
into why the decision was made to stop the trial.
Preliminary results from the FAME II trial reveal that of patients with
one or more significant lesions as determined by FFR guidance, those
treated with PCI plus OMT experienced superior outcomes. For patients
with one or more significant lesions there was a 7.6 times greater risk
of hospital readmission with revascularization for patients who received
OMT alone. Further, there was an 11.2 times greater risk of the need of
unplanned hospital readmission with urgent revascularization.
"While we are still analyzing the full data, what we have seen to date
confirms that an FFR-guided treatment strategy reduces the rate of
re-hospitalization, which has the potential to benefit the health of
patients and the bottom line of health care providers," said Dr. Bernard
De Bruyne, M.D., Ph.D., of the
OLV Clinic
in Aalst,
Belgium
, and
coordinating clinical investigator of the FAME II trial. "Whether a
patient needs PCI, or is better off with medical treatment, the data
thus far reveal that treatments based on FFR guidance provide superior
outcomes."
With additional data, the trial may provide new insights about the
benefits of coronary intervention and answer questions raised by the
COURAGE (Clinical Outcomes
Utilizing Revascularization
and Aggressive Drug Evaluation)
trial, which demonstrated no difference in the outcomes between PCI plus
OMT compared to OMT alone. However, the COURAGE trial did not require
use of PressureWire FFR measurement technology.
"Through FAME II, we now have additional evidence that PCI can help
improve patient outcomes when a treatment strategy is guided by FFR,"
said Frank Callaghan, president of the St. Jude Medical Cardiovascular
Division. "Going to the hospital a second or third time is both a burden
for patients and a burden on a hospital's resources. We expect
additional data will continue to reveal the important role that FFR
plays in developing an optimal treatment strategy."
The data to-date reveal that patients treated based on FFR guidance had
a lower risk for events and a reduced risk of readmission for treatment.
These positive preliminary findings help demonstrate that stenting
ischemic lesions and medical treatment of non-ischemic ones can improve
outcomes in patients with single or multivessel disease. Further data
are expected to be presented later this year.
About FFR
FFR is a physiological index used to determine the hemodynamic severity
of narrowings in the coronary arteries, and is measured using St. Jude
Medical PressureWire Aeris and PressureWire
Certus. 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 the Original FAME Trial
The original FAME (Fractional Flow Reserve (FFR) vs. Angiography in
Multivessel Evaluation) trial compared outcomes for patients whose
treatment was guided by FFR to those whose treatment was guided only by
angiography using St. Jude Medical PressureWire Certus technology.
Results demonstrated improved clinical outcomes in patients with stable
coronary artery disease and two or three vessel disease.
St. Jude Medical
is sponsoring a symposium on the clinical evidence
provided by the FAME-Trials on
Tuesday, May 15
from
17:00 to 18:30 p.m.
in Room 252AB.
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FAME-Trials Family: Physiology, Decision-Making and Clinical
Outcomes This session will provide an update on
clinical evidence offered by the FAME-Trials offering a better
understanding of the link between coronary physiology and clinical
outcomes. The session will include presentations and discussion on why
findings from the FAME-Trials should help change clinical practice.
Attendees can also visit
St. Jude Medical
at booth F8 and F9 on Level 1
of the exhibition hall during EuroPCR or visit us on the web for
show-specific information at: http://www.sjmprofessional.com/europcr.
EuroPCR is the official congress of the
European Association of
Percutaneous Cardiovascular Interventions
(EAPCI), a leading
international course for interventional cardiovascular specialists.
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.
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, including those described in the Risk Factors and
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Source:
St. Jude Medical
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