Clinical Trials
FAME Trial
Acronym: Fractional Flow Reserve Versus Angiography for Multivessel Evaluation
Purpose: Comparison of fractional flow reserve-guided percutaneous coronary intervention vs. angiography-guided percutaneous coronary intervention
Treatment Group: fractional flow reserve-guided percutaneous coronary intervention
Control group: Angiography-guided percutaneous coronary intervention
Number of Participants: 1,005
Centers: Multicenter
Inclusion Criteria: Multivessel coronary artery disease
Primary Outcome(s): Incidence of major adverse cardiac events at 1 year, including all-cause mortality, MI and repeat revascularization
Secondary Outcome(s):
- Major adverse cardiac events at 2 and 5 years
- Individual components of major adverse cardiac events at 1, 2 and 5 years.
Summary: The 1-year major adverse cardiac event rate was approximately 30% lower in the fractional flow reserve-guided group vs. the angiography-guided group. Rates of death/MI were also significantly lower with angiography-guided percutaneous coronary intervention. This effect persisted at 2 years. Major adverse cardiac events had occurred in 31% of the angiography-guided group vs. 28% of the fractional flow reserve-guided group at 4 years (RR = 0.91; 95% CI, 0.75-1.1). Multivariate analyses adjusting for potential confounders did not significantly alter the results. Individually, all-cause mortality occurred in 10% of the angiography-guided group vs. 9% of the fractional flow reserve-guided group (RR = 0.88; 95% CI, 0.59-1.29), myocardial infarction occurred in 12% vs. 9% (RR = 0.81; 95% CI, 0.56-1.16) and repeat revascularization occurred in 17% vs. 15%, respectively (RR = 0.9; 95% CI, 0.68-1.2). The researchers observed a significant interaction between treatment strategy and sex, favoring men in the fractional flow reserve-guided group (P = .027 for interaction). In an analysis limited to men, the primary endpoint occurred in 34% of those in the angiography-guided group vs. 27% of the fractional flow reserve-guided group (RR = 0.8; 95% CI, 0.64-0.99).
Original Publication:
van Nunen LX, et al. Lancet. 2015;doi:10.1016/S0140-6736(15)00057-4.
Link to Cardiology Today Article: