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 - 02/12/24
, Gerald Vanzetto, MD, PhD a, b, c, Nicolas Danchin, MD, PhD c, d, e, Philippe Gabriel Steg, MD c, f, g, h, Olivier Hanon, MD, PhD i, j, Clemence Charlon, MSc a, Sandra David-Tchouda, MD, PhD k, l, Gaetan Gavazzi, MD, PhD m, n, Tabassome Simon, MD, PhD c, o, p, q, Jean-Luc Bosson, MD, PhD k, rFor the
EVAOLD study investigator
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 noninferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, nonfatal myocardial infarction, nonfatal 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 1,756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show noninferiority with 80% power. Noninferiority based on exponential survival curves will be declared if the upper limit of the 1-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a noninferiority 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 noninferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients. ClinicalTrials.gov Identifier: NCT03289728.
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Vol 279
P. 94-103 - janvier 2025 Retour au numéro
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