Key result
Angiography-derived physiology fails to establish non-inferiority to wire-based methods for 12-month MACE.
Why the study?
Procedural complexity limits the use of wire-based FFR and iFR for intermediate coronary lesions, and direct evidence comparing angiography-derived methods with wire-based methods remained inconsistent.
Are angiography-derived physiological assessment methods non-inferior to wire-based methods in reducing major adverse cardiac events at 12 months in patients with intermediate coronary lesions?
Meta-Analysis (n=6,141)
Randomized controlled trials
Are angiography-derived physiological assessment methods non-inferior to wire-based methods in reducing major adverse cardiac events at 12 months in patients with intermediate coronary lesions?
Although 12-month MACE rates were not significantly different, angiography-derived physiological assessment failed to meet the pre-specified non-inferiority margin compared to wire-based assessment and resulted in more index revascularizations despite shorter fluoroscopy times.
Background: Wire-based methods-fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are the gold standard for physiological assessment of intermediate coronary lesions, but procedural complexity limits their use. Angiography-derived methods estimate FFR without a pressure wire or hyperemic agent. Direct evidence comparing angiography-derived with wire-based methods remains inconsistent. We assessed whether angiography-derived methods are non-inferior to wire-based methods for assessment of intermediate lesions and their impact on procedural burden. Methods: We systematically searched for randomized controlled trials (RCT). The primary outcome was major adverse cardiac events a composite of all-cause mortality (MACE), myocardial infarction, and revascularization at 12 months. Non-inferiority was assessed using a risk-difference (RD) margin of 3.0%. Secondary outcomes included fluoroscopy and procedure times, contrast volume, individual components of MACE, stent thrombosis, stroke, and procedural complications. Results: Three RCTs comprising 6141 patients (3089 [50.3%] assigned to angiography-derived methods) were included. MACE did not differ between groups (RD 0.85%; 95% confidence interval (CI) −2.92 to 4.62%; p = 0.436); the upper CI crossed the 3.0% non-inferiority margin. Fluoroscopy time was significantly shorter with angiography-derived methods, whereas total procedure time, contrast volume, and other secondary outcomes were comparable. Using angiography-derived methods led to more index revascularizations. Conclusions: MACE did not differ significantly between angiography-derived and wire-based methods for physiological assessment of intermediate coronary lesions. However, non-inferiority of angiography-derived methods could not be established. They led to a modestly lower fluoroscopy time, but more index revascularizations without any difference in total procedure time and contrast used.
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Mittal et al. (2026) conducted a meta-analysis in Intermediate coronary lesions (n=6,141). Angiography-derived physiological assessment vs. Wire-based physiological assessment (FFR and iFR) was evaluated on Major adverse cardiac events (MACE: composite of all-cause mortality, myocardial infarction, and revascularization) at 12 months (RD 0.85%, 95% CI -2.92 to 4.62%, p=0.436). Angiography-derived physiological assessment did not differ from wire-based methods in 12-month MACE (RD 0.85%; 95% CI -2.92 to 4.62%; p=0.436), failing to establish non-inferiority (3.0% margin).
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