May 21, 2012 -- St. Jude Medical Inc. announced that data from the FAME II trial demonstrated a significant difference in the need for urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with stable coronary artery disease. These highly statistically significant results validate the profound role that FFR-guided therapy has in improving patient outcomes. The preliminary data were presented at a late breaking trial session at EuroPCR.
The FAME II (Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) trial began enrolling patients in May 2010 with the goal of further studying the role of FFR in the treatment of stable coronary artery disease in one or more vessels. The trial compared clinical outcomes, safety and cost effectiveness of percutaneous coronary intervention (PCI) guided by FFR plus optimal medical treatment (OMT) to OMT alone in patient with stable coronary artery disease.
Earlier this year, St. Jude Medical announced that it was stopping enrollment in the FAME II trial after an Independent Data Safety Monitoring Board (DSMB) deemed it unethical to continue to randomize patients into the arm of the trial receiving optimal medical treatment alone. The DSMB found a highly statistically significant reduction in the need for unplanned hospital readmission and urgent revascularization when FFR-guided assessment was used to direct treatment in patients with coronary artery disease. The data presented provided background into why the decision was made to stop the trial.
Preliminary results from the FAME II trial reveal that of patients with one or more significant lesions as determined by FFR guidance, those treated with PCI plus OMT experienced superior outcomes. For patients with one or more significant lesions there was a 7.6 times greater risk of hospital readmission with revascularization for patients who received OMT alone. Further, there was an 11.2 times greater risk of the need of unplanned hospital readmission with urgent revascularization.
“While we are still analyzing the full data, what we have seen to date confirms that an FFR-guided treatment strategy reduces the rate of re-hospitalization, which has the potential to benefit the health of patients and the bottom line of health care providers,” said Dr. Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME II trial. “Whether a patient needs PCI, or is better off with medical treatment, the data thus far reveal that treatments based on FFR guidance provide superior outcomes.”
With additional data, the trial may provide new insights about the benefits of coronary intervention and answer questions raised by the COURAGE (Clinical Outcomes UtilizingRevascularization and Aggressive Drug Evaluation) trial, which demonstrated no difference in the outcomes between PCI plus OMT compared to OMT alone. However, the COURAGE trial did not require use of PressureWire FFR measurement technology.
“Through FAME II, we now have additional evidence that PCI can help improve patient outcomes when a treatment strategy is guided by FFR,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “Going to the hospital a second or third time is both a burden for patients and a burden on a hospital’s resources. We expect additional data will continue to reveal the important role that FFR plays in developing an optimal treatment strategy.”
The data to-date reveal that patients treated based on FFR guidance had a lower risk for events and a reduced risk of readmission for treatment. These positive preliminary findings help demonstrate that stenting ischemic lesions and medical treatment of non-ischemic ones can improve outcomes in patients with single or multivessel disease. Further data are expected to be presented later this year.
For more information: www.sjm.com
November 12, 2025 
