Preliminary Data Available for FAME II FFR Trial

St. Jude Medical began the FAME II trial in 2010 to compare the difference between percutaneous coronary interventions (PCI) guided by fractional flow reserve (FFR) technology and optimum medical therapy (OMT) used without FFR. FFR is an index that measures and compares the pressure proximal to a coronary artery obstruction to the pressure distal to that obstruction. In other words, it measures how much a given lesion impairs flow to the myocardium. In January, the company was asked by an independent Data Safety Monitoring Board (DSMB) to halt the trial due to elevated adverse effects in the medication-only group. The DSMB felt the trial had sufficiently demonstrated “highly statistically significant reduction in the need for hospital readmission and urgent revascularization when fractional flow reserve-guided assessment was used to direct treatment in patients with coronary artery disease,” according to a release issued by the company.

Now, St. Jude has announced the physical data from the trial, which provides background into why the trial was stopped in January. Preliminary results from the 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. For these patients there was also 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 healthcare 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.”

The industry is continuously testing the difference between PCI and OMT, but with the introduction of FFR technology, measurement could now become more objective. Previously, decisions on whether to stent or perform angioplasty on moderate blockages had to be assessed by a physician’s clinical opinion. FFR, however, provides a measurable way of determining treatment. Thus the FAME II trial was born, intended to test how the use of FFR can help decisions involving PCI.

With additional data, the trial may provide new insights about the benefits of coronary intervention and answer questions raised by the COURAGE (Clinical Outcomes Utilizing Revascularization 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 St. Paul, Minn.-based St. Jude Medical’s 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 available now 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 later this year.