St. Jude Medical Stops FAME II Enrollment Based on Positive Interim Analysis Data

January 18, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when fractional flow reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease. As a result of the positive interim analysis, the FAME II independent data safety monitoring board (DSMB) has recommended that investigators stop patient enrollment in the trial because the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) alone.

According to St. Jude Medical, the goal of the company-sponsored FAME II trial is to further study the role of FFR in the treatment of stable coronary artery disease by comparing OMT plus FFR-guided percutaneous coronary intervention (PCI) to OMT alone. In the trial, FFR is measured using St. Jude Medical's PressureWire Aeris and PressureWire Certus to specifically identify which coronary narrowings are causing ischemia and to guide the interventional cardiologist in determining which lesions warrant stenting. They hypothesize that this will result in improved patient outcomes and reduced health care costs.

The DSMB recommended that St. Jude Medical stop patient enrollment in this trial due to increased patient risk of major adverse cardiac events among patients randomized to OMT alone compared to patients randomized to OMT plus FFR-guided PCI. In particular, patients receiving OMT alone experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization. The DSMB determined that this difference was highly unlikely to change with inclusion of more patients. The data currently reflect no observed difference in the rates of death or heart attack, the company noted.

St. Jude Medical advised that the FAME II trial will continue following patients who are currently enrolled according to the trial protocol and will not enroll any new patients. The trial randomized 1,219 patients with stable coronary artery disease in 28 centers in the United States, Canada, and Europe. Data will be published as information is analyzed. The company expects that initial results will be presented in 2012.

“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,” commented Bernard De Bruyne, MD, Coordinating Clinical Investigator of the FAME II trial. “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.”

The company stated that the FAME II trial may provide new insights about the benefits of PCI and answer questions raised by the COURAGE trial. COURAGE demonstrated no difference in the outcomes between PCI plus OMT compared to OMT alone; however, that trial did not require use of FFR-measurement technology. William E. Boden, MD, et al published the COURAGE findings in the New England Journal of Medicine (2007;356:1503–1516).