St. Jude Halts FAME II Enrollment


Medical devices major St. Jude Medical (NYSE:STJ - News) will stop enrolling new patients in its FAME II clinical trial following positive results from an interim analysis.

The independent data safety monitoring board (“DSMB”) recommended investigators to halt patient enrollment in the study following the impressive results which have shown statistically significant reduction in the need for hospital readmission and urgent revascularization when fractional flow reserve (“FFR”)-guided assessment is used in treating patients with coronary artery disease.  

FFR is an index that identifies and measures the severity of coronary artery narrowing. It specifically locates the coronary narrowings which are responsible for occluding blood flow to a patient's heart muscle and directs the surgeons to identify the lesions requiring stenting. The approach is believed to help rein in healthcare costs and improve patient outcome.    

The company-sponsored FAME II trial is evaluating the use of St. Jude’s PressureWire FFR devices during the treatment of patient with stable coronary artery disease. The objective of the trial is 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 DSMB considered it unethical to continue randomize patients to OMT alone as patients experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization. The DSMB advised St. Jude to stop enrolling patients in the FAME II study given the higher risk of major adverse cardiac events in patients randomized to OMT alone versus “FFR-guided PCI plus OMT”. The board concluded that this difference was highly unlikely to change with the enrollment of additional patients.     

St. Jude said that the FAME II trial will continue to track the currently enrolled patients and will not add any new patients. The trial has enrolled 1,219 patients in 28 centers across the U.S., Europe and Canada. The company plans to publish initial results from the interim analysis this year.

Results from the original FAME trial showed that patients (with multivessel coronary disease) who received FFR-guided treatment experienced improved outcomes over time. The FAME II trial is expected to further project the benefits of FFR-guided PCI and its role in improving care for patients with coronary artery disease.

With its LightLab acquisition in July 2010, St. Jude emerged as the first company to offer a comprehensive lesion assessment product portfolio that includes the FFR technology and Optical Coherence Tomography (“OCT”), a next-generation imaging technology.

St. Jude reckons FFR and OCT, the two exciting emerging technologies, as the most important growth drivers in its vascular business, allowing it to compete in a roughly $600 million market. One of the company’s key competitors in the FFR space is Volcano Corp. (NasdaqGS:VOLC - News). We are currently Neutral on St. Jude, which is in tandem with a short-term Zacks #3 Rank (Hold).

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