From the DECISION-QFR trial, the Heart Team's treatment decisions based on the Quantitative Flow Ratio (QFR), which calculates FFR from contrast images in patients with multivessel coronary artery disease, were nearly identical to decision-making using FFR, as presented by Dr. Taku Asano of St. Luke's International Hospital at the Hotlines and Late-breaking trials session at EuroPCR 2022.
Heart Team Decision-Making Based on Angiography-Derived FFR: The DECISION-QFR Trial
The DECISION-QFR trial enrolled 260 patients with chronic coronary syndromes who had multivessel disease, including those with proximal LAD and who were deemed suitable for revascularization, from 10 centers in Japan between August 2020 and October 2021. Two heart teams consisting of cardiologists and cardiac surgeons were randomly assigned to a group in which the recommended treatment strategy (CABG only, equipoise [CABG or PCI], or PCI only) was determined based on the information provided, and the degree of concordance between the two groups' treatment recommendations was evaluated.
A total of 248 patients were included in the analysis, with a mean age of 70.8 years, 78.6% were male, 48.4% diabetic (of which 6% took insulin therapy), 23% currently smoked, 12.1% had a history of MI, 6.5% had peripheral artery disease, and 6.5% had a history of stroke. The mean LVEF was 59.3%, ≥50% stenosis was identified in an average of 3.9 lesions, 41.9% had 2-vessel disease, 58.1% had 3-vessel disease, and the mean anatomic SYNTAX score was 20.9. The estimated mortality rate at 10 years after PCI based on SYNTAX Score II 2020 was 36.1%, and 29.6% for CABG.
A total of 483 vessels were analyzed and between the QFR and FFR the Pearson’s R was 0.68 (0.63-0.73), while the area under the ROC curve for positive/negative prediction of FFR by QFR was 0.88 (0.84-0.91).
With regard to the functional SYNTAX scores between FSSQFR and FSSFFR, the agreement was almost perfect with an ICC of 0.94 (0.93-0.95) and a Pearson’s R of 0.94 (0.93-0.96), with the SYNTAX score quartile agreement of 91.9%.
There was also a near-perfect agreement regarding the 10-year mortality estimates after PCI from SYNTAX score II 2020 between SSII2020QFR and SSII2020FFR (ICC = 0.998 [0.998-0.999], Pearson's R = 0.998 [0.998-0.999]).
The Heart Team's concordance rate of recommended treatment was high at 91.5% (227/248 vessels, 76.2% PCI only/equipoise, 15.3% CABG only), with Cohen's kappa for the primary endpoint set at 0.73 (95%CI 0.62-0.83), exceeding the lower limit of 95%CI 0.40 for the pre-specified criterion, overall meeting the criteria.
In addition, the results of the evaluation of whether each vessel should be treated by PCI or CABG showed a concordance of 86.1% for PCI (Cohen's kappa 0.72 [95%CI 0.66-0.78]) and 88.0% for CABG (Cohen's kappa 0.72 [95%CI 0.66-0.78]) agreement.
The procedure time per vessel was 7.97 minutes for QFR and 8.38 minutes for FFR (p=0.035), and this difference was even greater for procedures following a predefined contrast protocol (76 vessels, 6.65 vs 10.17 minutes: p<0.001).
Dr. Asano summarized, “QFR can be calculated in a shorter time compared to FFR measurements and may enhance the practicability of physiology-guided decision-making for optimal revascularization.”
This report was published in Clinical Cardiology.
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