Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial (EVAOLD)

EVAOLD

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 587 patients aged 80 years or over with NSTEMI, a selective invasive strategy guided by stress imaging was not non-inferior to routine invasive management for death, myocardial infarction or stroke at 12 months.

N

587pazienti

Disegno

Multicentre (France), open-label, 1:1 randomised, two-arm parallel non-inferiority trial; 12-month follow-up; non-inferiority declared if the upper limit of the one-sided 97.5% CI for the hazard ratio is <1.24 (7% absolute margin); registry status "terminated" after a planned interim analysis

Esito

MACCE (all-cause death, non-fatal myocardial infarction, non-fatal stroke) at 12 months

Rilevanza

2Importante — uno dei diversi pilastri.

RisultatoRecruitment stopped for futility after 587 of the planned 1,756 patients. Death, myocardial infarction or stroke at one year occurred in 24.1% with the selective strategy and 20.7% with routine invasive management (HR 1.22, 95% CI 0.86–1.72; P = 0.27), so non-inferiority was not shown. The selective strategy did reduce the number of angiograms and their attendant complications.

Barone-Rochette G, et al. Presented at ESC Congress 2026, Hot Line 11, 31 August.

Discussione e critica

Sparing the very old an angiogram is an attractive idea and this trial could not show it is safe: the point estimate ran the wrong way, the confidence interval reached 1.72, and the data monitors stopped enrolment at a third of target for futility. That is not proof of harm — 587 patients and 130-odd events leave room for a smaller difference either way — but it removes the argument that stress imaging first is a defensible default at 80 and over. What the strategy did buy is fewer catheterisations; whoever wants to trade procedures for a possible excess of events now has to say so explicitly.