Key result
Screening CCTA with FAI-Score identifies ~52% of stable post-MI patients for targeted trial enrollment.
Why the study?
Residual coronary inflammation drives recurrent cardiovascular risk after MI despite guideline-directed secondary prevention. This trial tests whether the monoclonal antibody orticumab reduces local coronary inflammation in stable post-MI patients with an elevated FAI-Score despite well-controlled risk factors.
Does orticumab reduce local coronary inflammation (measured by percent change in mean FAI-Score) in clinically stable patients >6 months after type 1 myocardial infarction with elevated baseline FAI-Score?
RCT (n=185)
Double-blind
2:2:1:1
Yes
Does orticumab reduce local coronary inflammation (measured by percent change in mean FAI-Score) in clinically stable patients >6 months after type 1 myocardial infarction with elevated baseline FAI-Score?
CCTA-derived FAI-Score screening is a feasible enrichment strategy to identify clinically stable post-MI patients who harbor substantial residual coronary inflammation despite well-controlled risk factors on contemporary secondary prevention.
CCTA FAI-Score screening feasibly enriches stable post-MI patients with residual inflammation; supports targeted randomization in orticumab trials.
Background Residual coronary inflammation remains a driver of recurrent cardiovascular risk after myocardial infarction (MI), even in clinically stable patients receiving guideline-directed secondary prevention. The Fat Attenuation Index (FAI)-Score, derived from coronary computed tomographic angiography (CCTA), noninvasive measures local coronary inflammation associated with major adverse cardiovascular events. In a phase 2a pilot study, orticumab reduced coronary inflammation in patients with a high baseline FAI-Score. FORTIFY is a randomised clinical trial that aims to enroll patients with elevated FAI-Score after MI despite well-controlled risk factors. FORTIFY will test whether the monoclonal antibody orticumab reduces local inflammation. Methods FORTIFY is an ongoing, multicenter, randomised, double-blind, placebo-controlled, phase 2b trial of orticumab in clinically stable patients >6 months after type 1 MI. Participants must be on guideline-directed secondary prevention with well-controlled LDL-C, blood pressure, and glycemia. The entry criteria include elevated coronary inflammation defined as FAI-Score ≥75th centile in at least 1 coronary artery or ≥50th centile in at least 2 arteries. Eligible participants are randomised 2:2:1:1 to high-dose orticumab, low-dose orticumab, or matched placebo regimens. Follow-up CCTA is performed at 6 months. The primary endpoint is percent change from baseline in mean FAI-Score across the 3 major coronary arteries. Results of screening by FAI As of 25 February 2026, 185 participants underwent screening CCTA with FAI-Score assessment; 97 were eligible and 88 were not eligible for randomisation. In this clinically stable population >6 months after type 1 MI, FAI-Score centiles showed broad distribution in LAD, LCx, RCA, and the mean, providing the first description of FAI-Score centile distribution in a stable post-MI trial population. Across all screened participants, values spanned nearly the full 0–100 scale. LAD FAI-Score centiles ranged from 1% to 99% (mean 49.9%, SD 29.4). In the LAD, FAI score in eligible participants (n=97) ranged from 12% to 99% (mean 70.7%, SD 18.8), versus 1% to 72% (mean 26.5%, SD 20.0) in non-eligible participants (n=86). Similar patterns were observed for LCx and RCA. Conclusions These findings support the feasibility of use of FAI score as an enrichment strategy for residual coronary inflammation and support the choice of studying a stable population >6 months post-MI, where substantial coronary inflammation persists despite contemporary secondary prevention.
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Villines et al. (2026) conducted an RCT in Residual coronary inflammation after type 1 myocardial infarction (n=185). Orticumab vs. Matched placebo was evaluated on Percent change from baseline in mean FAI-Score across the 3 major coronary arteries at 6 months. Screening CCTA with FAI-Score identified 97 of 185 (52.4%) stable post-MI patients as eligible for orticumab randomisation, with mean LAD FAI-Score centiles of 70.7% vs 26.5% in non-eligible patients.
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