FFR-Guided Revascularization in Coronary Artery Disease Raises Concern

NEW ORLEANS — There is limited benefit—and greater harms—in using fractional flow-reserve (FFR)-guided angiography to treat patients with multi-vessel coronary artery disease (CAD), according to results from the FUTURE (FUnctional Testing Underlying coronary REvascularization; ClinicalTrials.gov identifier: NCT01881555) trial.

Gilles Rioufol, MD, PhD, of Hospices Civils de Lyon in France, presented the findings at the 2016 American Heart Association (AHA) Scientific Sessions, on behalf of the FUTURE investigators.  The purpose of the trial was to investigate the superiority of FFR-guided therapeutic management vs conventional management in patients with multi-vessel CAD.

One-year primary composite end points included all-cause mortality, myocardial infarction, repeat revascularization, and stroke. Participants with acute coronary syndrome and stable CAD randomly underwent either FFR-guided management or traditional management.

The researchers intended to include 1728 patients from 39 centers across France; however, an independent data safety monitoring board recommended that enrollment be stopped due to significantly greater mortality rates in the FFR group. The trial included 941 patients (aged 65 ± 10 years; 83% male) at that time.

Those individuals in the FFR-guided management group had FFR measured in each vessel with ≥50% coronary stenosis and underwent revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) only when FFR was ≤0.80. Conversely, those in the traditional management group underwent medical therapy only; the decision to conduct PCI or CABG was made based on patient angiogram.

The trial did not demonstrate any improvement in the composite end point after more than 50% of the anticipated recruitment, which suggested futility to pursue the trial, Dr Rioufol noted at an AHA press briefing.

Study limitations included a “lack of statistical power to conclude on the primary end point,” and similar all-cause mortality rates after study recruitment was halted (P =.07).

Disclosures: Dr Rioufol reports receiving research support from St. Jude Medical and Vocano, as well as honorarira from St Jude Medical and Astra Zeneca and consultant and advisory board fees from Saint Jude Medical and Boston Scientific. 

Reference

Rioufol G, Mewton N, Rabilloud M, et al. The functional testing underlying coronary revascularization (FUTURE) study: a “real world” comparison of fractional flow reserve-guided management vs conventional management in multi vessel coronary artery disease patients. Presented at: the 2016 American Heart Association Scientific Sessions. November 12-16, 2016; New Orleans, LA.