Medical devices major,
St. Jude Medical, Inc.
) recently announced results from the FAME II (FFR-Guided
(Fractional Flow Reserve) Percutaneous Coronary Intervention (PCI)
Plus Optimal Medical Treatment versus Optimal Medical Treatment
Alone in Patients with Stable Coronary Artery Disease) trial.
The study revealed that the FFR-guided treatment using St. Jude
Medical's PressureWire technology plus best available medical
therapy helps curb healthcare costs and improves patient
FFR is an index that identifies and measures the severity of
coronary artery narrowing. It specifically locates the coronary
narrowing, responsible for occluding blood flow to a patient's
heart muscle and directs surgeons to identify the lesions requiring
The company-sponsored FAME II trial evaluated the use of St. Jude's
PressureWire FFR devices (PressureWire Aeris or PressureWire
Certus) during the treatment of patients with stable coronary
artery disease. The objective of the trial was to study the role of
FFR in treating this condition by comparing FFR-guided percutaneous
coronary intervention ("PCI") plus optimal medical therapy ("OMT")
with OMT alone.
The trial had enrolled 1,220 patients in 28 centers across the
U.S., Europe and Canada since May 2010. Following the independent
data safety monitoring board's ("DSMB") recommendation, the
enrollment was stopped in January 2012.
Study Indicates Positive Results for St. Jude's
Results revealed that clinical outcomes are far more successful
when patients are treated with the FFR-guided stenting along with
the best available medical therapy, than with medical therapy (MT)
alone. Results at the end of the trial enrolment indicated that the
occurrence of primary end-point events such as urgent
revascularization, cardiac arrest and death, were lower at 4.3% in
patients treated with PCI plus MT than in patients treated with MT
Further, the study demonstrated that St. Jude's PressureWire FFR
measurement technology reduces the incidence of urgent
revascularization by 86% for patients under FFR-guided treatment.
However, there is no evidence that mortality rate or cardiac arrest
is lower in patients with PCI plus MT than in MT alone. Findings
suggest that the benefits of PCI plus MT might increase with time.
The study was published in the
New England Journal of Medicine
(NEJM) and also presented at the ESC Congress 2012 (European
Society of Cardiology).
The FAME II results are in sharp contrast to the COURAGE (Clinical
Outcomes Utilizing Revascularization and Aggressive Drug
Evaluation) trial which reported that the outcomes of PCI plus MT
and the MT alone were similar and the FFR technology is not
required. The FAME II trial proves that the FFR measurement is
beneficial in identifying patients who would benefit from medical
treatment, thereby reducing the occurrence of primary end-point
Results from the original FAME trial showed that patients (with
multivessel coronary disease) who received FFR-guided treatment
experienced improved outcomes over time.
St. Jude reckons FFR and Optical Coherence Tomography ("OCT"), the
two exciting emerging technologies, as being the most important
growth drivers in its vascular business, allowing it to compete in
a roughly $600 million market. One of St. Jude's key competitors in
the FFR space is
). We currently have a Neutral recommendation on St. Jude, which
carries a short-term Zacks #3 Rank (Hold).
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