• Myocardial Infarction
• Cardiology Clinical Trials
• Coronary Artery Disease
• Cardiology

• Myocardial Infarction
• Cardiology Clinical Trials
• Coronary Artery Disease

Guided management by fractional flow reserve (FFR) resulted in more patients with NSTEMI being allocated to medical therapy when compared with guided management by angiography alone. Colin Berry, FRCP, PhD, University of Glasgow, Glasgow, United Kingdom, presented data from the Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes study [FAMOUS NSTEMI; NCT01764334].

Currently, visual interpretation of diagnostic angiography is important in determining the need for revascularization in patients with NSTEMI. FFR has a class I recommendation in stable coronary artery disease, but there is insufficient evidence for a recommendation in acute coronary syndromes. Lesion-level ischemia is associated with increased risk of ischemic events, as prior studies have shown that lesions with an FFR ≤ 0.80 benefit from revascularization with either coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI). The hypothesis of the multicenter FAMOUS NSTEMI trial was that routine FFR is not only feasible in patients with NSTEMI but adds diagnostic, clinical, and economic benefits when compared with the current standard: angiography-guided management [Berry C et al. Am Heart J. 2013].

The primary outcome of the study was the proportion of patients who were administered medical management only at baseline. Secondary outcomes were the feasibility and safety of routine FFR, association between FFR and severity of stenosis, major adverse cardiac events (MACEs), resource use, and quality of life [Berry C et al. Am Heart J. 2013].

In this prospective clinical trial, 350 patients with intermediate- to high-risk NSTEMI were randomized to management that was guided by both angiography and FFR or by angiography alone. In the angiography-guided group, FFR was measured but not disclosed to clinicians or patients. Treatment decisions for any patient were left to the discretion of the treating physician. FFR was successful in 100% of patients, with a 0.03% rate of wire dissections. The treatment plan was altered in 22% of patients after FFR was disclosed, which decreased the number of patients treated with revascularization and type 4 myocardial infarctions (MIs).

FFR-guided management increased the number of patients allocated to medical therapy at the time of angiography (22.7% vs 13.2%; P = .02). A similar relationship was seen at 1 year, although this did not achieve statistical significance.

The rate of MACEs at 1 year was similar in both arms (log rank P = .79). The rates of procedure-related type 4 MIs and spontaneous MIs were similar in both arms; however, there was evidence that procedure-related type 4 MIs were greater in the FFR-guided arm compared with the angiography-guided arm (P = .12).

In conclusion, Prof Berry stated that the data from the FAMOUS NSTEMI trial suggest that FFR is feasible and safe and that the results can influence clinical decision making for patients with NSTEMI. However, Prof Berry noted that a larger trial is needed to further evaluate the clinical outcomes and cost-effectiveness of FFR-guided management of patients with NSTEMI.

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