Fractional flow-reserve (FFR)-guided revascularization may not be a safe treatment strategy decision tool in patients with multivessel coronary artery disease (CAD), according to the results of the FUTURE Trial presented Nov. 14 during AHA 2016.

In a multicenter, controlled, randomized trial, Gilles Rioufol, MD, PhD, et al., explored FFR-guided revascularization in comparison with angioplasty alone among patients with multivessel CAD. Acute coronary syndrome and stable coronary artery disease consecutive patients were randomized to either FFR-guided management or traditional management. The primary end point was a composite of major adverse cardiovascular events, including all-cause death, non-fatal heart attack, stroke and repeat coronary revascularization at one year.

The trial was scheduled to include 1,728 patients over 39 centers in France. The study’s independent data safety monitoring board recommended to stop study enrollment due to a significant greater mortality in the FFR-group after analysis of the first 836 randomized patients.

The interim results for the 933 included patients show at least a non-significant excess of mortality trend in the FFR group and no clinical benefit of FFR in comparison with angioplasty.

Researchers conclude that in complex, high-risk patients, FFR may not help for treatment decisions and could be associated with a negative safety signal.

"Unfortunately, the Data Safety Monitoring Board stopped the trial prematurely and therefore the trial is not informative," commented Deepak L. Bhatt, MD, MPH, FACC. "I do sympathize with and commend the investigators for presenting the trial, as researchers have an obligation to present all human research. However, there is nothing here that should influence current clinical practice."

"The early termination of this study leaves behind questions without definitive answers," adds Richard A. Chazal, MD, FACC, president of the ACC.

Keywords: AHA16, American Heart Association, AHA Annual Scientific Sessions, Acute Coronary Syndrome, Cardiac Surgical Procedures, Coronary Artery Disease, Disease Management

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