FAME II Results Aid St. Jude


Medical devices major, St. Jude Medical, Inc. (STJ) 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 outcome.

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 stenting.

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 FFR

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 alone (12.7%).

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 events.
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 Volcano Corp. (VOLC). We currently have a Neutral recommendation on St. Jude, which carries a short-term Zacks #3 Rank (Hold).

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