FAMOUS-NSTEMI - FAMOUS-NSTEMI

Sep 01, 2014
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
British Heart Foundation
Date Presented:
01/01/2014
Date Published:
01/01/2014
Date Updated:
09/01/2014
Original Posted Date:
09/01/2014
References

Description:

The goal of the trial was to evaluate a fractional flow reserve (FFR)-guided strategy compared with a coronary angiography-guided strategy among participants with non–ST-segment elevation myocardial infarction (NSTEMI).

Hypothesis:

An FFR-guided strategy will increase the proportion of patients managed medically.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Participants with NSTEMI and planned invasive therapy within 72 hours or recurrent ischemic symptoms within 5 days
  • At least one coronary stenosis ≥30% for which FFR could have diagnostic value

    Number of enrollees: 350
    Duration of follow-up: 6 and 12 months
    Mean patient age: 62 years
    Percentage female: 26%

Exclusions:

  • Refractory angina
  • Hemodynamic instability
  • STEMI
  • Intolerance to antiplatelet drugs
  • Ineligible for coronary revascularization
  • Planned valve surgery
  • History of coronary artery bypass grafting
  • Severe coronary artery disease (CAD) (i.e., diffuse calcification) or nonobstructive CAD (i.e., <30% stenosis)
  • Limited life expectancy

Primary Endpoints:

  • Proportion of patients allocated to medical management

Secondary Endpoints:

  • Safety of routine FFR measurement
  • MACE

Drug/Procedures Used:

Participants with NSTEMI were randomized to an FFR-guided strategy (n = 176) versus a coronary angiography-guided strategy (n = 174).

All coronary stenoses ≥30% underwent FFR. The FFR value was disclosed to the operator in the FFR-guided group, and revascularization was recommended for FFR ≤0.8. The FFR value was not disclosed to the operator in the angiography-guided group, and revascularization was according to operator discretion.

Concomitant Medications:

  • Aspirin: 99%
  • P2Y12 inhibitor: 100%
  • Statin: 95.5%
  • Beta-blocker: 91.5%

Principal Findings:

Overall, 350 patients were randomized. The mean age was 62 years, 26% were women, 41% were current smokers, 13% had a prior MI, and 15% had diabetes.

FFR was measured in 704 lesions, of which 61.1% were hemodynamically significant. Two dissections were attributable to the FFR wire. FFR resulted in a change in treatment plan in 22% of participants.

The proportion of patients treated medically was 22.7% in the FFR group vs. 13.2% of the angiography group (p = 0.022).

- Major adverse cardiac events (MACE) at 12 months: 8.0% vs. 8.6% (p = 0.89), respectively
- MACE, excluding periprocedural MI at 12 months: 5.7% vs. 2.9% (p = 0.25), respectively
- Periprocedural MI: 2.8% vs. 6.3% (p = 0.12), respectively
- Spontaneous MI: 4.0% vs. 2.9% (p = 0.69), respectively
- Freedom from revascularization at 12 months: 21.0% vs. 13.2% (p = 0.054), respectively

Interpretation:

Among patients with NSTEMI, an FFR-guided strategy was feasible. An FFR-guided strategy changed the initial treatment plan in approximately one-fifth of cases and resulted in a larger proportion of patients treated medically compared with an angiography-guided strategy. MACE were similar between treatment groups, although periprocedural MI tended to be higher in the angiography-guided group, and spontaneous MI tended to be higher in the FFR-guided group.

References:

Layland J, Oldroyd KG, Curzen N, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS–NSTEMI randomized trial. Eur Heart J 2014;Sep 1:[Epub ahead of print].

Presented by Dr. Colin Berry at the European Society of Cardiology Congress, Barcelona, Spain, September 1, 2014.

Keywords: Myocardial Infarction, Coronary Stenosis, Coronary Angiography, Hemodynamics, Diabetes Mellitus, ESC Congress


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