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Results from the FAVOR III China Trial Presented at TCT and Published Simultaneously in the Journal of the American College of Cardiology

BOSTON – September 19, 2022 – New results from the FAVOR III China Trial found that QFR-guided lesion selection for percutaneous coronary intervention (PCI) improved two-year clinical outcomes compared with standard angiography guidance. The benefits were most pronounced among patients in whom QFR assessment altered the planned revascularization strategy.

Findings were reported today at TCT 2022, the 34^th annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

QFR enables online estimation of fractional flow reserve (FFR) without the use of a pressure wire or pharmacologic agents to induce hyperemia. FAVOR III China was an investigator-initiated, multicenter, sham-controlled blinded randomized trial that compared QFR guidance with standard angiography guidance for lesion selection and monitored outcomes post procedure. The pivotal randomized FAVOR III China demonstrated that lesion selection for PCI using QFR guidance improved one-year clinical outcomes compared with conventional angiographic guidance.

Among the 3,825 randomized participants, two-year major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization (IDR), occurred in 8.5% of patients in the QFR-guided group compared to 12.5% of patients in the angiography-guided group (HR 0.66, 95% CI 0.54-0.81, p<0.0001). This was driven by fewer MIs (4.0% vs. 6.8%, HR 0.58, 95% CI 0.44-0.77, p=0.0002) and IDRs (4.2% vs. 5.8%; HR 0.71, 95% CI 0.53-0.95, p=0.02) in the QFR-guided group. In addition, results were consistent within the first year and between one to two years (p_int=0.99).

Compared with the pre-randomization intended lesion selection based on angiography guidance, the revascularization strategy was changed after randomization in 445 (23.3%) patients in the QFR-guided group and 119 (6.2%) in the angiography-guided group (P<0.0001), due to treatment deferral of at least one vessel originally intended for PCI (19.6% vs. 5.2% respectively, P<0.0001) and unplanned PCI of at least one vessel not originally intended to be treated (4.4% vs. 1.5% respectively, P<0.0001). PCI was performed less frequently, fewer stents and less contrast were used, and the residual SYNTAX score was lower in the QFR-guided group compared with the angiography-guided group in those patients who had the PCI strategy changed.

Although the MACE rate at two years was lower with QFR guidance in both patients in whom the pre-planned PCI revascularization strategy changed (HR 0.34, 95% CI 0.21-0.55) and did not change (HR 0.70, 95% CI 0.56-0.88) after randomization, those with strategy changes had a greater relative reduction in MACE (p_int=0.009), driven by better outcomes in patients in whom vessels that had been intended to be treated were deferred after QFR assessment. Patients with pre-PCI QFR-concordant versus non-concordant treatment had a lower risk of two-year MACE (8.8% vs. 17.2%, P<0.0001) and MACE excluding PMI (6.1% vs. 11.9%, P<0.0001). This benefit of QFR-concordant treatment was present in both patients randomized to QFR guidance and angiography guidance.

“Two-year outcomes of a QFR-guided vessel and lesion selection strategy showed that the benefits of QFR guidance continued to accrue over time compared with standard angiography guidance in patients undergoing PCI,” said Lei Song, MD, Professor of Interventional Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. “Improvement was greatest among patients in whom the PCI strategy was modified by QFR as well as those who had QFR-concordant PCI. Longer-term follow-up is needed to determine whether the 2-year benefits of QFR guidance for PCI lesion selection are preserved, increase or diminish over time.”

The study received grant support from the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital (Grant No. NCRC2020001), Beijing Municipal Science and Technology Commission (Grant No. Z191100006619107), and National High Level Hospital Clinical Research Funding (Grant Number: 2022-GSP-GG-20). Pulse Medical (Shanghai, China) provided the QFR system and software at no charge for the study.

Dr. Song had no disclosures to report.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 30 years, CRF has helped accelerate medical breakthroughs and educated doctors on the latest treatments for heart disease. CRF’s centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 34^th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.

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