FFR decreased stent procedures in patients with non-STEMI

BARCELONA, Spain — Results from the FAMOUS NSTEMI trial have shown that in addition to being safe and feasible, use of fractional flow reserve in patients with non-STEMI also reduced the rate of unnecessary stent implantations.

Perspective from Dipti Itchhaporia, MD, FACC

“While FFR reduces revascularization, the consequence is optimization of these procedures, which become safer,” Colin Berry, MD, PhD, study investigator of the University of Glasgow, United Kingdom, told Cardiology Today’s Intervention.

In the FAMOUS NSTEMI trial, Berry and colleagues randomly assigned 350 patients with non-STEMI to treatment guided by FFR (n=176) or angiography (n=174). Patients were included if they had possible obstructive CAD of at least one stenosis ≥30% severity that was amendable to revascularization. Before randomization in the cath lab, the cardiologist set the treatment plan — optimal medical therapy (OMT) only, PCI or CABG — based on the clinical information and angiographic findings. FFR was measured in all participants, but only disclosed to the attending clinical staff in the FFR-guided group.

Colin Berry

According to Berry, in the FFR group, patients with an FFR >0.8 were given medical therapy, whereas those with an FFR ≤0.8 were treated with revascularization. In the angiography group, treatment followed standard care.

In the FFR group, the initial treatment strategy of PCI plus OMT (n=144) was changed to OMT in 25 cases and CABG in two cases. Four of the patients planned for CABG plus OMT (n=14) underwent PCI and two received OMT only, and four of the patients planned for OMT only (n=18) received PCI and one received CABG. Overall, FFR disclosure was associated with a change in the initial treatment plan in 21.6% of the patients.

The primary endpoint — adoption of OMT alone after randomization in the cath lab — was significantly higher in the FFR-guided group vs. the angiography-guided group post-randomization (22.7% vs. 13.2%; P=.022), and there was a trend toward a higher rate of OMT adoption at 1 year in the FFR-guided group (P=.054).

“This trial demonstrated that FFR was feasible in 100% of patients in whom it was attempted. It was also safe, with guidewire-related dissections occurring in two (0.03%) patients,” Berry said during a presentation. “This resulted in a reduction in … stenting and open-heart surgery and optimization of these procedures.”

There were also trends in the reduction of duration of hospital stay and costs, Berry said, and a trend toward improved quality of life at 12 months in the FFR-guided group compared with the angiography-guided group.

“One of the main conclusions from this developmental study is that a larger … trial is needed to further assess the impact of routine FFR-guided management in [non-STEMI] for health outcomes and cost effectiveness,” he said. – by Brian Ellis

For more information:

Berry C. Hot Line IV. Myocardial Infarction. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.

Disclosure: Berry reports receiving travel support from Pfizer and is one of the trial investigators who serves as a consultant/speaker for St. Jude Medical and/or Volcano Corp. St. Jude Medical provided the pressure wires to the six hospitals that participated in the study.

Perspective

Dipti Itchhaporia, MD, FACC

The question most of us have is whether FFR is reliable. We know that in STEMI, it is difficult to get the vasodilation and measure an accurate FFR. It was an interesting observation in this study that FFR is feasible and safe in patients with non-STEMI. In some ways it’s also provocative because if you do an FFR, you may also be able to avoid doing some of the noninvasive other studies to risk stratify these patients. This may offset the cost of doing FFR, which is the other issue. If you do an FFR on every patient that comes in with a non-STEMI, how much would you save? There is also the possibility that if you do FFR and decide to defer the intervention, some patients will later have acute MI. Despite that, you are still saving money by not putting the stent in. So that is going to be a hard sell, especially when patients could be unstable. There is going to have to be really good data to justify that decision in a medical/legal environment. My sense is most interventionalists are not going to change their practice habits based on this study.

Dipti Itchhaporia, MD, FACC

Robert and Georgia Roth Endowed Chair for Excellence in Cardiac Care

Director of Disease Management

Hoag Memorial Hospital Presbyterian, Newport Beach, Calif.

Past Chair, ACC Board of Governors

Disclosures: Dipti reports no relevant financial disclosures.