FFR Shows Benefit in FAME II; Enrollment Halted

January 18, 2012

January 18, 2012 (St Paul, Minnesota) — An interim analysis of the FAME II study-- which is comparing fractional-flow-reserve (FFR)–guided stenting with optimal medical treatment (OMT) compared with OMT alone--has shown a clear benefit of the FFR-guided approach and, as a result, the independent data safety monitoring board (DSMB) has recommended that patient enrollment be stopped [1]. "The DSMB considers it unethical to continue to randomize patients to OMT alone," notes St Jude Medical in a statement.

The analysis revealed a statistically significant reduction in the need for hospital readmission and urgent revascularization when FFR-guided assessment was used to direct treatment in patients with coronary artery disease (CAD) in FAME II, it adds.

FFR is a physiological index used to determine the hemodynamic severity of narrowings in the coronary arteries and is measured using St Jude Medical's PressureWire Aeris and PressureWire Certus. FFR specifically identifies which narrowings are responsible for obstructing the flow of blood to the heart and guides the interventional cardiologist in determining which lesions warrant stenting, "resulting in improved patient outcomes and reduced healthcare costs," the company notes.

FAME II has randomized 1219 patients with stable CAD in 28 centers in Europe, the US, and Canada; those who are already participating will continue to be followed according to the trial protocol, but no new patients will be enrolled. Currently, there is no difference in the rates of death or MI between the two study arms, says St Jude, noting that initial results from the trial will be presented this year.

FAME II was designed to look at PCI in the wake of the COURAGE trial, which demonstrated no difference in outcome between PCI plus OMT compared with OMT alone. However, COURAGE did not require use of FFR-guided stenting.

Wells Fargo analyst Larry Biegelsen notes [2]: "The FAME II data reinforce the positive outcomes seen in the earlier FAME I trial, which demonstrated a 25% reduction in major adverse coronary events (MACE) in patients undergoing FFR-guided PCI vs PCI alone. We think the FAME II results are good news for PCI in general because they will support the use of PCI in stable CAD patients (about 40% of all PCI patients), which has come under fire since the COURAGE study was presented in 2007."

Coordinating clinical investigator of the FAME II trial, Dr Bernard De Bruyne (OLV Clinic in Aalst, Belgium), says in the St Jude press release: "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 CAD."

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