St. Jude touts positive Fame II study results; safety board urges enrollment halt

Good news from St. Jude Medical ($STJ) this morning. A data safety monitoring board has recommended that investigators halt enrollment in the Fame II study after seeing that fewer coronary artery disease patients were readmitted to the hospital when fractional flow reserve (FFR)-guided assessment was used in conjunction with optimal medical therapy. In fact, the board deemed it "unethical" to treat trial subjects with optimal medical therapy alone, as more patients randomized to this group faced hospital readmission and revascularization procedures.

FFR is measured using St. Jude Medical's PressureWire Aeris and PressureWire Certus and helps identify those coronary narrowings that are responsible for obstructing the flow of blood to a patient's heart muscle. The company has touted the approach as a way to save the healthcare system money because FFR measurements can help eliminate unnecessary stenting procedures and guide doctors toward the correct treatment for each patient, according to the St. Jude website.

Last year, a study published in the Journal of the Medical Association found that in nearly 12% of nonemergency situations in which percutaneous coronary interventions were used, they were unnecessary, according to the Los Angeles Times. The most well-known procedure is angioplasty, during which a stent is inserted to keep the blood vessel open.

This new data gives St. Jude hope about the future of FFR-guided therapy. "The Fame II trial is unprecedented in its ability to provide further answers and evidence regarding the optimal way to treat patients with coronary artery disease and myocardial ischemia," said Bernard De Bruyne, of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the Fame II trial, in a statement. "What we observed to date regarding urgent revascularizations validates the profound role that FFR-guided therapy has in improving patient outcomes. This is further evidence that FFR should be considered the standard of care for patients with coronary artery disease."

In light of the data, investigators will continue to monitor currently enrolled patients. The company expects initial results from the trial sometime this year.

News of the positive data comes roughly a week after St. Jude said it expected net sales of about $1.4 billion for the fourth quarter of 2011, an increase of about 4% versus the same period of 2010. Company execs expressed optimism about the results. "MedTech fundamentals weakened during the second half of 2011," Daniel Starks said in a statement. "We therefore are especially pleased with our sales results, with two of four divisions exceeding our fourth-quarter guidance."

The company will discuss its Q4 results more fully Jan. 25.

- see the St. Jude release