FAVOR III China Trial Evaluates QFR-Guided Lesion Selection for PCI

November 4, 2021—The FAVOR III China trial found that lesion selection for percutaneous coronary intervention (PCI) using the noninvasively assessed physiologic measurement quantitative flow ratio (QFR) improved outcomes for PCI compared with a standard angiography-guided strategy.

The trial findings were reported at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online and in Orlando, Florida, on November 4-6. The study was published simultaneously online by Bo Xu, MBBS, et al in The Lancet.

According to TCT, FAVOR III China is an investigator-initiated, multicenter, blinded, randomized, sham-controlled trial that compared QFR and angiography for lesion selection and monitored outcomes for 1-year postprocedure.

TCT noted that QFR is derived from three-dimensional coronary artery reconstruction and fluid dynamics computations from the angiogram. QFR enables online estimation of fractional flow reserve (FFR) without the use of a pressure wire or pharmacologic agents to induce hyperemia. Previous studies have demonstrated the feasibility and accuracy of online QFR assessment in assessing the hemodynamic significance of coronary stenoses compared with pressure wire–based FFR measurement.

As summarized in the TCT press release, FAVOR III China was composed of patients with stable or unstable angina pectoris or those > 72 hours post–myocardial infarction (MI) who had at least one lesion with a diameter stenosis between 50% and 90% in a coronary artery with a reference vessel diameter ≥ 2.5 mm by visual assessment. These patients were randomized 1:1 to a QFR-guided strategy (PCI performed only if QFR ≤ 0.80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment).

Between December 2018 and January 2020, 3,825 patients at 26 sites were randomly assigned to QFR-guided PCI (n = 1,913) or angiography-guided PCI (n = 1,912). Patient characteristics included the following: mean age, 62.7 years; 70.6% male; 33.9% with diabetes; 63.5% who presented with an acute coronary syndrome; and 54% with multivessel diseases.

All patients, post–catheterization lab physicians, and research personnel were blinded to treatment allocation. Participants in both arms underwent a preset 10-minute delay for real or sham QFR calculation before PCI. The target vessels intended to be treated with standard angiography guidance were declared by operators and recorded before randomization.

TCT reported that the primary endpoint of the 1-year rate of major adverse cardiac events (MACE; a composite of death from any cause, MI, or ischemia-driven revascularization) was 5.8% for the QFR-guided group compared to 8.8% for the angiography-guided PCI group (hazard ratio [HR], 0.65; 95% CI, 0.51-0.83; P = .0004).

The major secondary endpoint (1-year rate of MACE, excluding periprocedural MI) was 3.1% for the QFR-guided group versus 4.8% for the angiography-guided group (HR, 0.64; 95% CI, 0.46-0.89; P = .0073).

Dr. Xu, Director of Catheterization Laboratories at Fuwai Hospital in Beijing, China, commented in the TCT announcement, “A QFR-guided vessel and lesion selection strategy improved 1-year clinical outcomes compared with standard angiography guidance in patients undergoing PCI, due both to fewer procedural complications and superior long-term results. The simplicity and safety of QFR compared with wire-based physiologic measurements should facilitate the adoption of physiologic lesion assessment into routine clinical practice.”