FAME II trial results published in New England Journal of Medicine


St Jude Medical has announced results of the FAME II trial demonstrating that patients with fractional flow reserve (FFR)-guided stenting plus the best available medical therapy had superior outcomes to those treated with medical therapy alone. Results published online in the New England Journal of Medicine (NEJM) and presented during a Hot Line session at the ESC (European Society of Cardiology) Congress 2012 revealed that use of the PressureWire (technology used to measure blood flow restriction in the coronary arteries) yielded an 86% relative risk reduction for unplanned re-admission to the hospital with urgent revascularisation in patients with stable coronary artery disease.

The FAME II trial (FFR-guided percutaneous coronary intervention (PCI) plus optimal medical treatment vs. optimal medical treatment alone in patients with stable coronary artery disease) examined the role of FFR in the treatment of stable coronary artery disease in one or more vessels. FFR specifically identifies which coronary narrowings are responsible for obstructing blood flow to a patient’s heart muscle, and is measured using PressureWire FFR measurement technology from St Jude Medical. The randomised trial compared percutaneous coronary intervention (PCI) guided by FFR plus the best available medical therapy to medical therapy alone.

Results from the FAME II Trial:


  • At the time trial enrolment ended, primary endpoint event occurrence (death, heart attack or urgent revascularisation) was significantly lower in patients with PCI plus medical therapy than in patients with medical therapy alone (4.3 versus 12.7%).
  • Instances of hospital re-admission leading to urgent revascularisation were reduced by 86% for patients in the FFR-guided PCI arm of the trial. There was no evidence of significant difference in mortality or heart attack between patients with PCI plus medical therapy and patients with medical therapy alone.
  • Analysis suggests that the benefits of PCI plus medical therapy may increase over time.

“The FAME II trial provides new evidence-based guidance demonstrating the profound role that FFR and second-generation drug eluting stents can have in improving patient care,” said Bernard De Bruyne, OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME II Trial. “Though there have been questions in the past about whether a patient should have a stent or is better off with medical treatment, we now know that if a lesion is significant as determined by FFR guidance, the stenting procedure will provide a better outcome. With this new knowledge, I believe that FFR should become the standard of care for treating patients with stable coronary artery disease and significant coronary narrowings.”

The FAME II trial provides insights about the benefits of coronary intervention and answers questions raised by the COURAGE (Clinical outcomes utilizing revascularization and aggressive drug evaluation) trial. The COURAGE trial demonstrated no difference in the outcomes between PCI plus medical therapy compared to medical therapy alone, but did not require use of FFR measurement technology. FAME II demonstrates that use of PressureWire FFR measurement technology has the ability to make a measurable difference in the outcome of patients. Where FFR found no evidence of ischaemia-producing narrowings, patients were treated with medical treatment alone and were followed up in a registry. The rate of primary endpoint events for these patients was low (3%), indicating that FFR measurements can be beneficial in directing which patients would benefit from medical treatment.

“As the sponsor of the FAME family of studies, St Jude Medical is proud to provide the medical community with additional evidence supporting the critically important role that the PressureWire FFR measurement technologies play in improving patient outcomes,” said Frank Callaghan, president of the St Jude Medical Cardiovascular Division. “Publication of this groundbreaking research in the
New England Journal of Medicine coinciding with a Hot Line session during ESC demonstrates that the role of FFR in guiding medical care has moved to broader and more mainstream acceptance within the cardiology community.”

The FAME II trial began enrolling patients in May 2010. At the time enrolment was stopped in January 2012, 1,220 patients with stable coronary artery disease were enrolled at 28 centres across Europe, the USA and Canada.

Enrolment in the FAME II trial was halted after an Independent Data Safety Monitoring Board (DSMB) found a highly statistically significant reduction in unplanned hospitalisations and urgent revascularisations in patients enrolled in the PCI plus medical therapy arm of the trial. The DSMB therefore deemed it unethical to continue to randomise patients into the arm of the trial receiving medical therapy alone. As a result, patients already enrolled in the trial continue to be followed, but no additional patients were added.

Health economics data derived from the FAME II trial are expected to be presented later this year.