Sex-Consistent Performance of an AI-Enabled ECG for Acute Myocardial Infarction: The ROMIAE Study

초록

Background Women with suspected acute myocardial infarction (AMI) are at increased risk of delayed or missed diagnosis. Artificial intelligence–enabled electrocardiogram (AI-ECG) may support earlier AMI detection, but prospective evidence for sex-consistent performance and rule-out safety is limited. Objectives The purpose of this study was to evaluate sex-stratified diagnostic performance, rule-out safety, and phenotype robustness of an AI-ECG for AMI in a prospective, multicenter emergency department cohort. Methods ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) was a prospective external validation study at 18 centers in South Korea. Adults with suspected AMI were enrolled. AI-ECG analyzed initial ECGs using prespecified risk thresholds. Diagnostic performance was assessed using the area under the receiver-operating characteristic curve. Rule-out safety was evaluated by sensitivity, negative predictive value, and missed AMI rate at the low-risk cutoff. All analyses were sex-stratified, with prespecified subgroup analyses. Results Among 8,493 patients, 3,186 were women. AI-ECG demonstrated comparable discrimination in women and men (area under the receiver-operating characteristic curve 0.875 [95% CI: 0.853-0.896] vs 0.871 [95% CI: 0.858-0.883]). At the prespecified low-risk cutoff, rule-out sensitivity was 98.8% (95% CI: 97.0-99.5) in women and 99.8% (95% CI: 99.4-100.0) in men, with high negative predictive value (99.2% [95% CI: 97.9-99.7] in women and 99.1% [95% CI: 96.7-99.7] in men) and low missed AMI rates (<1% in both sexes). Performance remained stable across ST-segment elevation and non–ST-segment elevation myocardial infarction, without degradation in women. Conclusions In a prospective, multicenter emergency department cohort, AI-ECG demonstrated sex-consistent diagnostic performance and preserved rule-out safety for AMI. Further validation and implementation studies are warranted. (ROMIAE [Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis] Trial; NCT05435391)

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