Fractional flow reserve-guided percutaneous coronary intervention plus best medical therapy improved outcomes when compared with medical therapy alone in patients with stable coronary artery disease in the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2 (FAME 2) trial.
A composite outcome of death from any cause, nonfatal myocardial infarction, or urgent revascularization within 2 years occurred in 8.1% of 447 patients who had at least one stenosis with a fractional flow reserve (FFR) of 0.80 and were randomized to undergo percutaneous coronary intervention (PCI) performed on the basis of the FFR, compared with 19.5% of 441 such patients who received medical therapy alone.
The difference was driven mainly by a 77% reduction in the need for urgent revascularization in interventional group as compared with the medical therapy group (4.0% vs. 16.3%, hazard ratio, 0.23). The overall rates of death and myocardial infarction did not differ significantly between the groups, Dr. Bernard D. Bruyne of the Cardiovascular Center Aalst, Belgium, and his colleagues reported at the annual congress of the European Society of Cardiology.
The findings of the open-label, randomized, multicenter trial were simultaneously published online Sept. 1 (N. Engl. J. Med. 2014 Sept. 1[doi:10.1056/NEJMoa1408758]).
The improved outcomes in the PCI group were the result of outcomes that occurred between 8 days and 2 years after randomization; in the first 7 days, more primary end-point events occurred in the PCI group than in the medical therapy group (2.2% vs. 0.9%, hazard ratio 2.49).
The rate of the primary endpoint was 9.0% among 332 additional patients who had an FFR of more than 0.80 in all stenoses, were enrolled into a registry, and received medical therapy alone, the researchers said.
The original FAME trial studied the procedure in patients who had already been selected for PCI. Compared with patients whose PCI was guided by angiography alone, those whose PCI was guided by FFR had significantly reduced rates of the composite end point of death, nonfatal myocardial infarction, and repeat revascularization at 1 year (N. Engl. J. Med. 2009;360:213-24).
FAME 2 evaluated use of FFR for improving the benefits of initial stenting as an alternative to noninvasive medical therapy. The trial was halted after a median of 7 months’ follow-up, when data safety and monitoring board found a highly statistically significant reduction in hospital readmission and urgent revascularization in the patients who received FFR-based stenting compared with those who received optimal medical therapy alone.
FAME 2 was supported by St. Jude Medical. Dr. De Bruyne reported that his institution receives grant support and consulting fees on his behalf from St. Jude Medical. Detailed disclosure information for several other authors is available with the full text of the article at www.NEJM.org.