Using Artificial Intelligence to Adjudicate Major Adverse Cardiovascular Events in Clinical Trials

Marti-Castellote, PM; Badrouchi, S; Claggett, B; Xu, D; Maddah, M; Khurshid, S; Vardeny, O; Lewis, EF; Jhund, PS; Desai, AS; Ellinor, PT; Ho, JE; McMurray, JJV; Pfeffer, M; Solomon, SD; Cunningham, JW

doi:10.1016/j.jacc.2025.10.055

Using Artificial Intelligence to Adjudicate Major Adverse Cardiovascular Events in Clinical Trials

J Am Coll CardiolPublished 9 Nov 2025Validation study of an artificial intelligence (AI)-based adjudication system within the PARADISE-MI randomised trial

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Authors' conclusion

AI-based adjudication of MACE showed high agreement with human CEC adjudication, especially for CV death and stroke, and where the model was confident.

Study context

Population: Patients with myocardial infarction (MI) complicated by systolic dysfunction or pulmonary congestion in the PARADISE-MI global trial (sacubitril/valsartan vs ramipril)PARADISE-MI
Participants: 5,661 patients

Comparison: Auto-MACE vs clinical events committee (CEC) adjudication

Primary result

As reported in the abstract

Agreement of Auto-MACE with CEC adjudication

Confident adjudication: deaths: 315/455 (69%)
Confident adjudication: potential MIs: 301/659 (46%)
Confident adjudication: potential strokes: 136/167 (81%)
Agreement with CEC, confident events: deaths: 97%
Agreement with CEC, confident events: potential MIs: 89%
Agreement with CEC, confident events: potential strokes: 88%
Agreement with CEC, all events: deaths: 86%
Agreement with CEC, all events: potential MIs: 76%
Agreement with CEC, all events: potential strokes: 84%

Further findings

Outcome	← Lower risk with Sacubitril/valsartan ←→ Higher risk with Sacubitril/valsartan →	HR (95% CI)
Effect of sacubitril/valsartan vs ramipril on composite MACE, by adjudication methodSacubitril/valsartanvs RamiprilAuto-MACE adjudication	0.512	0.91 (0.78–1.07)
Effect of sacubitril/valsartan vs ramipril on composite MACE, by adjudication methodSacubitril/valsartanvs RamiprilCEC adjudication	0.512	0.90 (0.77–1.05)
	0.512Hazard ratio (log scale)

Effect of sacubitril/valsartan vs ramipril on composite major adverse cardiovascular events (MACE), by adjudication method

Similar estimated effect with Auto-MACE and CEC adjudication

Original publication

Using Artificial Intelligence to Adjudicate Major Adverse Cardiovascular Events in Clinical Trials. J Am Coll Cardiol. Published 9 November 2025. doi:10.1016/j.jacc.2025.10.055

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