Prof PW Serruys from the CORRIB Research Center for Advanced Imaging and Core Laboratory, University of Galway, Ireland and local PIs of the Pioneer IV trial published this very important paper in the Eur Heart Journal as a Rapid Communication. The PIONEER IV (NCT04923191) is a multicentre, 1:1 randomized, open-label, all-comer, non-inferiority trial comparing clinical outcomes of PCI guided by QFR vs usual care, enrolling patients irrespective of clinical presentation or lesion complexity with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent.
This is the interim-analysis of the first 1270 patients (60% of the entire study population), with 631 randomized to the Medis QFR arm and 639 to the usual care arm, with a 1 year FU in 622 (98.6%) and 618 (96,7%), respectively. The mean number of implanted stents and the total stent length per patient were 1.6 stents and 34.0 mm in the QFR arm and 1.6 stents and 34.8 mm in the usual care arm. Intravascular imaging was used in 4.6% and 5.3% of the QFR and usual care patients, respectively. Post-PCI physiology was assessed in 76.5% of the QFR arm patients, with 17.9% (56/313) having an angio-FFR < 0.91, leading to additional treatment in 19.6% (11/56) of cases. The 1-year POCE rates were 6.9% in the QFR arm and 6.8% in the usual care arm. With a risk difference of 0.11%, non-inferiority was declared. The authors concluded that, QFR-guided PCI was non-inferior to usual care; these results must be confirmed in the whole population of 2130 patients.