Critical review · Mar 22, 2026
PIONEER IV (interim analysis): QFR-guided PCI versus usual care
Serruys PW, Tsai TY, et al. Angiography-derived fractional flow reserve- vs usual care-guided percutaneous coronary intervention: interim analysis of the PIONEER IV trial. Eur Heart J. 2026.
doi:10.1093/eurheartj/ehag174 · Randomized non-inferiority trial, 26 European sites, all-comer population
Summary
In the interim analysis, QFR-guided PCI was declared non-inferior to usual care. The patient-oriented composite endpoint (POCE) occurred in 6.9% with QFR and 6.8% with usual care (non-inferiority p 0.015).
In the usual care arm, 41% of patients had physiological assessment (FFR or an angiography-derived index) and 59% had none.
Strengths
- Randomized, multicenter, in an all-comer population.
Methodological issues
- Non-inferiority hypothesis for a tool meant to improve decisions. Non-inferiority makes sense when QFR replaces FFR: same outcome, no pressure wire. That is what FAVOR III Europe tested. In PIONEER IV, 59% of usual care used no physiology. For those patients, QFR is an addition, and the hypothesis should be superiority.
- Heterogeneous comparator. 41% of the usual care arm used FFR or angiography-derived physiology, and 59% used none. It is unclear against what QFR was shown to be non-inferior.
Opinion
“Not worse” is not a reason to adopt. If QFR adds no benefit over a usual care that used no physiology in 59% of cases, there is no reason to adopt it. The question raised by FAVOR III Europe remains open.