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QFR-Guided Revascularisation Shows No Catch-Up Risk After Year One Versus FFR
At 2-year follow-up in the FAVOR III Europe trial, major adverse cardiac events occurred in 9.7% of patients guided by QFR versus 7.4% guided by FFR — a trend toward higher risk with QFR that did not reach statistical significance (HR 1.34, 95% CI 0.98–1.81; p=0.064). Importantly, a landmark analysis from year one to year two showed virtually identical event rates between the two strategies, suggesting the gap observed at 12 months did not widen further over the subsequent year.
What Was Studied
This 2-year follow-up analysis of the FAVOR III Europe trial examined whether the previously demonstrated inferiority of QFR-guided revascularisation, relative to FFR guidance, persisted or resolved beyond the initial 12-month period. The primary focus was the composite endpoint of all-cause death, myocardial infarction, and unplanned revascularisation, with additional interest in whether excess risk was temporally confined or accumulating over time.
How It Was Studied
FAVOR III Europe was a multicentre, randomised, open-label, non-inferiority trial enrolling 2,000 patients with intermediate coronary artery stenoses across 34 European medical centres. Patients were randomised to receive either QFR-guided or FFR-guided revascularisation decisions. The original trial reported 12-month outcomes; this report extends follow-up to 2 years, comparing rates of major adverse cardiac events (MACE) between groups using unadjusted Cox regression analysis for superiority. A landmark analysis was also conducted to isolate the event rates occurring specifically between the 1- and 2-year timepoints, separating earlier from later outcome trajectories.
What Was Observed
- 2-year cumulative MACE rates were 9.7% in the QFR group and 7.4% in the FFR group — an approximately 34% higher relative risk in the QFR arm (HR 1.34, 95% CI 0.98–1.81; p=0.064). The confidence interval just crosses 1.0, meaning the difference falls short of conventional statistical significance, and the result remains inconclusive regarding a true underlying difference.
- Landmark analysis from 1 to 2 years revealed identical MACE rates of 3.2% in both the QFR and FFR groups (HR 0.97, 95% CI 0.58–1.62; p=0.92). This near-perfect equivalence in the second year indicates no ongoing divergence in outcomes after the initial 12-month period, and the wide confidence interval reflects the relatively small number of events in this interval.
- The excess risk associated with QFR guidance was therefore confined entirely to the first year of follow-up, consistent with the original trial’s finding of non-inferiority failure. No late hazard attributable to QFR-guided decision-making was detected in the second year of observation.
Why This Matters
The FAVOR III Europe trial had already established that QFR-guided revascularisation failed to meet non-inferiority criteria against FFR at 12 months. This extended analysis clarifies the temporal character of that disadvantage — the gap between strategies does not continue to expand beyond the first year, which is relevant for understanding when and why the two physiological assessment methods may diverge in clinical outcomes. The finding that event rates converge from year one onward provides important information about the trajectory of angiography-based versus pressure-wire-based approaches to coronary revascularisation decisions, informing how clinicians and researchers should interpret long-term safety data for QFR as an FFR surrogate.
How to Read This Result
Although this is a large, well-designed multicentre RCT, the 2-year MACE comparison did not achieve statistical significance (p=0.064, HR 1.34, 95% CI 0.98–1.81), leaving genuine uncertainty about whether a real residual difference exists between strategies, and longer follow-up or larger samples would be needed to resolve this question definitively.
Limitations
The abstract does not explicitly report study limitations.