Quantitative flow ratio-guided PCI improved 2-year MACE vs. angiography-based strategy
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BOSTON — Quantitative flow ratio-guided decision-making improved outcomes in patients with angina or recent MI vs. a standard angiography-guided strategy, regardless of whether preplanned PCI was performed or not, a speaker reported.
The findings were primarily driven by the deferral of vessels initially pre-planned for PCI after QFR guidance, according to the 2-year results of the FAVOR III China trial presented at TCT 2022 and simultaneously published in the Journal of the American College of Cardiology.
“As we know, in the multicenter, randomized, sham controlled FAVOR II China trial, quantitative flow ratio-based lesion selection improved 1-year clinical outcomes when compared with conventional angiographic guidance for percutaneous coronary intervention,” Lei Song, MD, from the department of cardiology at the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing, said during a press conference. “However, whether these early gains would be preserved, increase or diminish over time is uncertain, an issue of particular interest among those patients in whom the preplanned revascularization strategy was altered by QFR.”
In the FAVOR III China trial, researchers enrolled 3,825 patients with angina or recent MI to either a QFR-guided PCI strategy — defined as PCI performed only if QFR 0.8 — or a standard angiography-guided strategy to assess the impact of QFR guidance on outcomes (mean age, 63 years; 29% women).
As Healio previously reported, QFR-guided PCI was associated with lower rates of the primary outcome of MACE, defined as all-cause death, MI or ischemia-driven revascularization, compared with angiography-guided PCI at 1 year (HR = 0.65; 95% CI, 0.51-0.83; log-rank P = .0004).
In the present analysis, Song and colleagues presented the 2-year outcomes of the QFR-guided PCI strategy compared with standard angiography.
At 2 years, the primary composite endpoint of MACE occurred in 8.5% patients assigned to QFR-guidance and 12.5% of patients assigned to angiography (HR = 0.66; 95% CI, 0.54-0.81; P < .0001).
The researchers stated that the lower 2-year MACE observed in the QFR-guided group was primarily driven by lower rates of MI (4% vs. 6.8%; HR = 0.58; 95% CI, 0.44-0.77; P = .0002) and ischemia-driven revascularization (4.2% vs. 5.8%; HR = 0.71; 95% CI, 0.53-0.95; P = .02) compared with the angiography-guided group.
Revascularization strategy was changed after randomization for 23.3% of the patients in the QFR-guided group and 6.2% in the angiography-guided group (P < .0001), due to treatment deferral of at least one vessel originally intended for PCI or unplanned PCI of at least one vessel not originally intended for PCI, according to the study.
Song and colleagues reported that, although the 2-year MACE was lower in the QFR-guided group compared with angiography both in patients in whom the pre-planned PCI revascularization strategy changed (HR = 0.34; 95% CI, 0.21-0.55) and did not change (HR = 0.7; 95% CI, 0.56-0.88), patients whose treatment strategy was changed had a greater degree of improvement in MACE outcomes (P for interaction = .009). This finding was driven by reduced 2-year MACE in patients with vessels intended for PCI but deferred after QFR guidance (P for interaction = .009).
“Two-year follow-up of the multicenter, sham-controlled FAVOR III China trial demonstrated that a QFR-guided strategy of lesion selection for PCI improved 2-year clinical outcomes compared with standard angiography guidance, with incremental increasing benefit over time,” Song said during the presentation. “The reduction in MACE was most pronounced in patients in whom QFR assessment directed changes in the pre-PCI revascularization plan and in whom a QFR-concordant PCI strategy was performed. Longer-term follow-up is needed to determine whether the 2-year benefits of QFR guidance for PCI lesion selection are sustained or further increase.”
Following the presentation of the FAVOR III data, Eric A. Cohen, MD, FRCPC, deputy head of the division of cardiology at Sunnybrook Health Sciences Centre in Toronto, Canada, and Gary S. Mintz, MD, senior medical adviser for the Cardiovascular Research Foundation, further discussed the utility of QFR in clinical practice.
“[QFR] automates the process, perhaps a bit too much,” Cohen said. “At least that's one of the concerns, if the operator is taken out of the equation. It's a little bit like excessive reliance on the autopilot in the cockpit.”
“What we don't know is whether all of these [physiology assessment] systems are generically equivalent or whether they are some proprietary differences,” Mintz added.
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First of all, I don't think the difference between 1 year and 2 years really adds much to the clinical message that was delivered last year, showing this fairly large and, to me, hard to understand difference between the two groups. The main issue is we started to use pressure measurements to overcome limitations of angiography. Hoping that just putting together two views and some good software can completely overcome these limitations to me is childish. I confess, it will be quite difficult to adopt a technique widely once you don't believe in the rationale of it. I might be biased.
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Song L, et al. Late-Breaking Clinical Science in Coronary Artery Disease: Session V, in Collaboration With The Lancet. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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