Two-Year FAME Results Show Benefit of FFR Guidance

September 24, 2009—TCT Daily, the conference newspaper for the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco, reported that 2-year results from the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trial presented at this year's meeting confirm and extend the 1-year results reported at TCT 2008. The results demonstrate that patients with multivessel disease experience a significant decrease in major adverse cardiac events (MACE) if they undergo percutaneous coronary intervention (PCI) guided by standard angiography plus fractional flow reserve (FFR) measurements. The new results also show a reduction in myocardial infarction (MI) risk with FFR guidance. William F. Fearon, MD, presented the results at TCT 2009.

According to TCT Daily, Dr. Fearon's presentation showed that the total number of MACE was 105 in the FFR group and 139 in the angiography-alone group. This translated into significantly lower rates of MI and death/MI, as well as a strong trend for lower death/MI/coronary artery bypass graft/repeat PCI with FFR-guided treatment. Survival free of MACE was 4.5% higher in the FFR group versus the angiography alone-group.

"The 2-year follow-up of the FAME study demonstrates durability of the improved outcomes noted at 1 year with an FFR-guided approach to PCI in patients with multivessel coronary artery disease," commented Dr. Fearon. He noted that the improvements seen in the risk of MI and other adverse events were particularly important. "At 2 years, there is now a significant decrease in the rate of MI in the FFR-guided arm. There continues to be a significant decrease in death and MI favoring the FFR-guided approach. There is also a strong trend toward a lower rate of death, MI, or the need for repeat revascularization in the FFR-guided arm."

The FAME trial was conducted at 14 participating centers in Europe and six participating centers in the United States. The trial included 509 patients with multivessel coronary artery disease who underwent PCI guided by angiography and FFR and 496 treated with PCI and standard angiography alone. The two groups were matched for age, sex, and risk factors such as diabetes, hypertension, hyperlipidemia, smoking history, previous PCI, and previous MI. The average number of indicated lesions per patient was 2.8 in the FFR group and 2.7 in the standard angiography group. The average number of stents per patient was 1.9 in the FFR group and 2.7 in the standard angiography group, reported TCT Daily.