FAME 2 Trial

Acronym: Fractional Flow Reserve Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment

Purpose: Comparison of outcomes, safety and cost-effectiveness of fractional flow reserve-guided percutaneous coronary intervention and optimal medical treatment vs. optimal medical treatment alone in patients with stable coronary artery disease

Format: Prospective, randomized

Treatment Group: Fractional flow reserve-guided percutaneous coronary intervention plus optimal medical treatment

Control group: Optimal medical treatment only

Number of Participants: 1,220

Centers: 29

Countries: Worldwide

Inclusion criteria: Patients with angiographically significant stenoses, in whom at least one stenosis was hemodynamically significant (fractional flow reserve ≤ 0.80)

Primary Outcome(s):

  • Major adverse cardiac events, defined as a composite of all-cause death, documented myocardial infarction and unplanned hospitalization leading to urgent revascularization

Secondary Outcome(s):

  • Overall major adverse cardiac events at 5 years
  • Non-urgent revascularization procedures
  • Cost and cost-effectiveness
  • Functional class
  • Number of anti-anginal medications
  • Cerebrovascular events

Summary: At 5 years, the primary endpoint occurred in 13.9% of the fractional flow reserve-guided group vs. 27% of the optimal medical treatment group (HR = 0.46; 95% CI, 0.34-0.63). The difference was driven by urgent revascularization, which occurred in 6.3% of the fractional flow reserve-guided group vs. 21.1% of the optimal medical treatment group (HR = 0.27; 95% CI, 0.18-0.41), but also by spontaneous myocardial infarction. The difference between the two groups continued to increase after 3 years. There were no significant differences between the groups in death or myocardial infarction.

Original Publication:

Xaplantens P, et al. N Engl J Med. 2018; doi:10.1056/NEJMoa1803538.

Link to Cardiology Today Article: