Rationale and design of the multicentric randomized EVAOLD trial: evaluation of a strategy guided by imaging versus routine invasive strategy in elderly patients with ischemia.

Abstract

Background: The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain.

Study design: EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥ 80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be non-inferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, non-fatal myocardial infarction, non-fatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show non-inferiority with 80% power. Non-inferiority based on exponential survival curves will be declared if the upper limit of the one-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a non-inferiority margin of 7% in absolute difference and an event rate of 40% in the INV group.

Conclusion: EVAOLD is a nationwide, prospective, open-label trial testing the non-inferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients.

Clinicaltrials: gov Identifier: NCT03289728.