EVAOLD: selective care fails to show noninferiority in older NSTEMI

At 25 French centers, doctors assigned patients aged 80 and older who had been hospitalized with non-ST-segment elevation myocardial infarction (NSTEMI), the most common type of heart attack, to one of two paths. The EVAOLD trial was stopped after 587 of 1,756 planned patients had entered it: the chance of showing that selective care was no worse than routine care had become too low.

The question was whether stress imaging could act as a filter. This noninvasive test briefly makes the heart work harder with a drug while doctors image it using echocardiography or single-photon emission computed tomography (SPECT). Only patients showing moderate to severe disease then received angiography. The routine strategy sent every participant directly to angiography, which uses contrast dye injected through a catheter to visualize coronary blood flow and allows blocked arteries to be reopened when needed.

The main outcome combined death from any cause, nonfatal myocardial infarction and nonfatal stroke at one year. It occurred in 24.1% of patients assigned to selective management, compared with 20.7% assigned to routine invasive management. The hazard ratio was 1.22, with a 95% confidence interval of 0.86 to 1.72 and p=0.27. Because the trial was designed to test whether selective care was not meaningfully worse, the result did not establish that standard angiography was superior; it showed that selective care had not demonstrated noninferiority.

So what changes in practice? For clinicians treating older NSTEMI patients, the trial argues against replacing routine angiography with stress testing as the default route. Selective care did reduce angiography and related complications, but it did not demonstrate noninferiority for major cardiovascular events—and the researchers found the strategy challenging to put into practice in this population.

Professor Gilles Barone-Rochette of University Hospital of Grenoble, La Tronche, France, said the findings must be read alongside the early termination and lower-than-anticipated event rates. EVAOLD therefore offers a clear boundary rather than a final measure of every patient’s risk: stress imaging may spare procedures, but this trial did not demonstrate noninferiority to routine invasive management.