Lower MACE Risk With FFR- vs Angio-Guided PCI in AS Patients: FAITAVI

PARIS, France—Patients with severe symptomatic aortic stenosis (AS) and stable intermediate CAD undergoing TAVI may be at lower risk of MACE when coronary revascularization is guided by fractional flow reserve (FFR) instead of angiography, according to the results of the FAITAVI trial.

In the multicenter RCT, the 12-month incidence of all-cause death, MI, ischemia-driven TVR, disabling stroke, or major bleeding was 8.5% in the FFR-guided group and 16.0% in the angiography-guided group (HR 0.52; 95% CI 0.27-0.99), a benefit driven by fewer deaths and TVR.

In his presentation here at EuroPCR 2025, Flavio Ribichini, MD (University of Verona, Italy), said that more than half of patients who present for TAVI also have CAD present on their diagnostic evaluation, but there is an evidence gap about the role of coronary physiology in their optimal management that has not been addressed by prior trials or guidelines.

“With the FFR strategy, you spare nearly 30% of treatment,” he said. An analysis of patients in whom PCI was deferred based on the results of FFR showed that they did as well at 1 year as those who underwent revascularization.

To TCTMD, Ribichini said trials like this FAITAVI are needed because guidelines are outdated and not based on solid, randomized evidence that revascularization should be the norm. The European Society of Cardiology/European Association for Cardio-Thoracic Surgery give a class IIa, level of evidence C recommendation for PCI only in severe AS (> 70% stenosis affecting the proximal coronary vessel). The American College of Cardiology/American Heart Association give a class 2a, level of evidence C recommendation for PCI of the left main or proximal segment before TAVI. 

“This is what most people have been doing, and [are] still doing everywhere,” he said. “It is changing because we have shown that . . . performing PCI [in all cases] is not clearly useful and it might even be harmful.”

The data on how to handle these patients remain conflicted and differ based on extent of coronary disease.

The REVASC-TAVI registry found no clinical benefit of PCI in patients with stable CAD detected on TAVI evaluation. In patients with severe, symptomatic aortic stenosis as well as at least one proximal stenosis of 70% or greater in a major epicardial coronary artery suitable for PCI, ACTIVATION found that revascularization did not improve the odds of surviving or staying out of hospital over the next 12 months.

NOTION-3, however, did find that those with stable CAD and severe AS had better outcomes at 2 years with PCI before TAVI than those treated with a conservative strategy.

Stephan Windecker, MD (Bern University Hospital, Switzerland), the discussant for the trial during the late-breaking session, said FAITAVI provides additional thinking on this topic, but also raises additional questions.

He pointed out that in those who did undergo PCI based on FFR, the percentage of complete revascularization was higher than for those in the angiography-guided group, at 99% versus 77%.

Windecker also noted that “the follow-up period of 1 year is too short and precludes assessment for long-term differences in ischemia-related outcomes.” Additionally, at a mean age of 86, it may be difficult to ascertain the prognostic impact of either strategy on this elderly population, he said.

FAITAVI

The trial enrolled 320 patients (42% women) with combined significant CAD and severe AS undergoing TAVI. Patients were randomized to an angiography- versus physiology-guided coronary revascularization strategy at 15 sites in Italy. Diabetes was present in more than 35%, and the mean STS score was 3% in the FFR group and 4% in the angiography group.

In the angiography group, all lesions ≥ 50% in a vessel > 2.5 mm were treated. In the physiology arm, lesions with FFR ≤ 0.80 were treated and those > 0.85 were deferred. It was recommended that all FFR values between 0.81 and 0.85 have a repeat measurement after TAVI implantation.

PCI was performed concomitant with TAVI prior to valve implantation in 42% of the FFR group and 40% of the angiography group, and it was done concomitant with TAVI after valve implantation in 18% and 24%, respectively; before TAVI in 16% and 12%; and after TAVI in 24% in each group. Ribichini said the staged procedures were performed within 1 month in most cases.

TAVI device success according to VARC-2 criteria was 93% and 92%, respectively, with FFR and angiography.

All-cause death was lower in the FFR-guided group at 2.4% at 1 year versus 7.7% in the angio-guided group (HR 0.31; 95% CI 0.10-0.96). No ischemia-driven revascularization occurred in the FFR group, with three cases in the angiography group. Rates of stroke were 0.6% and 2.5%, respectively (HR 0.24; 95% CI 0.03-2.11).

In terms of safety endpoints, no differences were seen between groups for major bleeding, acute kidney failure, periprocedural MI, and vascular complications.

Ribichini agreed with Windecker that the advanced age of the FAITAVI population is a significant limitation that may preclude understanding how FFR-guided management would play out in younger, less comorbid patients.

Both the panelists and some audience members wondered why lesions were selected for PCI with an angiographic value of ≥ 50% rather than the guideline-recommended cutoff of 70%.

Ribichini said this was done due to prior evidence that patients with severe aortic stenosis may have a greater level of myocardial mass that is not reflected accurately when measured. More myocardial mass induces ischemia, he said, even in less angiographically severe lesions.

Ribichini also was asked about the possibility of using a wire-free measure of physiology, such as quantitative flow ratio (QFR), which might be of particular relevance in an elderly, fragile population to avoid any risk of harm that could be caused by pressure wire. That is being investigated in FAITAVI 2, he said.