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Mortality link with FFR questioned in FUTURE trial
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NEW ORLEANS — The FUTURE trial, designed to evaluate the impact of therapeutic management guided by fractional flow reserve or conventional angiography, was halted early due to an excess of all-cause mortality among patients who received the fractional flow reserve strategy.
However, follow-up data on available patients enrolled before the study stopped showed a persistent but nonsignificant difference in all-cause mortality at 1 year between the two groups.
In the safety analysis that led to trial discontinuation, among the first 836 patients enrolled, 17 (4%) assigned the FFR-guided strategy and seven (2%) assigned the angiography-guided strategy died (HR = 2.39; P = .0193). CV deaths accounted for 72% of all deaths, Gilles Rioufol, MD, PhD, from Hospices Civils de Lyon, France, reported at the American Heart Association Scientific Sessions.
Among the 797 patients enrolled who reached 1-year follow-up (85% of the population), the rate of all-cause death was 3.9% in the FFR group vs. 1.8% in the angiography group (HR = 1.98; 95% CI, 0.85-4.6; P = .11), and the rate of CV death was 2.7% vs. 1.3%, respectively (HR = 1.88; 95% CI, 0.7-5.01; P = .16). Additionally, the rate of the primary endpoint at 1 year — death, MI, stroke or revascularization — was not significantly different between the two groups (HR = 1.09; 95% CI, 0.76-1.56; P = .63).
“The FUTURE trial does not demonstrate any improvement in the composite endpoint of death, MI, revascularization or stroke after more than 50% of the recruitment, suggesting futility to pursue the trial,” Rioufol said during a press conference.
The randomized, open-label, controlled all-comers study was conducted at 31 centers in France. Target enrollment in the trial was 1,728 participants. Those enrolled had stable or stabilized angina and multivessel disease (> 50% stenosis) including the left anterior descending artery. The mean age was 60 years, most were men, one-third had diabetes and one-quarter had a history of MI. Almost half of the patients in both groups presented with ACS.
Patients were randomly assigned in a 1:1 fashion to the FFR-guided or angiography-guided strategy. Only lesions with FFR 0.8 were included in the analysis. The investigators then decided, based on assessment, to treat patients with PCI, CABG or optimal medical therapy.
FFR-related complications were observed in 0.8% of patients.
One-year follow-up of all patients is currently ongoing, and results are expected in May 2017, Rioufol said.
“This diagnostic test has revolutionized the management of patients with coronary disease. We know from many other studies that the safety profile [of FFR] is acceptable,” Herbert D. Aronow, MD, MPH, director of interventional cardiology, Cardiovascular Institute, and director of cardiac cath labs at Rhode Island and The Miriam Hospitals, Providence, Rhode Island, said during a discussion of the FUTURE results.
“I think not only would it have been unethical to continue the trial in order to demonstrate harm, but I think it would have been unlikely that harm would have been demonstrated,” he said.
He also noted that FFR guidance was associated with less resource use up front, with 7% lower use of PCI.
Looking at the future of FFR, Aronow said he believes cardiologists should “assume FFR is safe and, until proven otherwise, assume that there is no difference in MACE between FFR-guided and angiography-guided strategies.” – by Katie Kalvaitis
Reference:
Rioufol G, et al. LBCT.02 – Pioneering the Future of HeART Interventions. Presented at: American Heart Association Scientific Sessions; Nov. 12-16, 2016; New Orleans.
Disclosure: Rioufol reports receiving research support from St. Jude Medical and Volcano; honoraria from AstraZeneca and St. Jude Medical; and consulting and/or serving on advisory boards for Boston Scientific and St. Jude Medical.
Perspective
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Vincent Bufalino, MD, FAHA
The results of FUTURE make one pause and ask the question if FFR is as beneficial to patients as standard care. Practically, we also have a concern that in an individual patient, FFR doesn’t always answer the question. The judgment of the interventionalist seems to sway the decision more often than not. This raises the issue that we have to be careful and not let FFR totally guide thinking. Having good judgment is still the most valuable thing in terms of managing these patients.
This is only one trial, so it may be too early for the findings to change how doctors use FFR in everyday practice. It will make those who have been a bit negative about FFR more energized. Overall, FFR has been very helpful and has changed practice patterns, helping us get better answers for cases that look borderline. It will still be utilized.
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