The non-invasive QFR-guided PCI approach is superior to the angio-guided PCI approach!

Today, November 4, 2021, Mr. Xu Bo, Dept of Cardiology, Fuwai hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, presented the results of the FAVOR III China Outcome trial entitled “A sham-controlled Randomized Trial Comparing QFR-guided and angiography-guided PCI” as a Late-Breaking Clinical Trial (LBCT) at the TCT2021 congress.

FAVOR III China
This prospective study includes 3825 patients from China in which the QFR-guided PCI was compared with an angiography-guided PCI based on standard visual angiographic assessment. The hypothesis was that the non-invasive QFR-guided approach would be superior to the angio-guided approach.

The authors are to be congratulated on the excellent 1-year follow-up results, which have demonstrated that the 1-year primary endpoint (MACE) occurred in 5.8% of the participants in the QFR-guided group and in 8.8% of the participants in the angio-group, a highly significant difference of -3%!

Given the fact that the great majority of the PCI’s worldwide is still based on visual interpretation, this outcome should have far-reaching consequences for the daily clinical practice of PCI. Based on this solid evidence of the FAVOR III China trial and previously published data, the clinical guidelines should be revised to make the use of non-invasive image-based coronary physiology the preferred approach in the planning and the treatment of patients with coronary artery disease admitted to the cardiac catheterization laboratory. This non-invasive approach has many undeniable advantages for the patient, the healthcare professionals and the healthcare system in general. Benefits include no pressure wire insertion, no need to use adenosine, stent sizing is supported, treatment effect can be predicted, PCI quality can be assessed immediately after procedure, and all on a cost-effective basis.

Medis QFR trials
The QFR analyses in the FAVOR III China trial were performed with the Pulse AngioPlus product, based on the innovative and proprietary Medis’ QFR® system.

The Medis QFR® is FDA and CE approved and commercially available for clinical usage in the USA, EU and over 30 other countries worldwide. This FAVOR III China trial is the first in a series of major QFR outcome trials. The next one is the Medis’ sponsored FAVOR III EU/JP outcome trial, including 2000 patients and comparing QFR to FFR on a non-inferiority basis, with enrolment completed in the course of 2022