ABSTRACT

METHODS - Patients admitted with clinical suspicion of NSTE-ACS in the Capital Region of Copenhagen, Denmark were screened for inclusion in the VERDICT trial (ClinicalTrials.gov NCT02061891). Patients with ECG changes indicating new ischemia and/or elevated troponin, in whom ICA was clinically indicated and deemed logistically feasible within 12 hours, were randomized 1:1 to ICA within 12 hours or standard invasive care within 48-72 hours. The primary endpoint was a combination of all-cause death, non-fatal recurrent myocardial infarction, hospital admission for refractory myocardial ischemia or hospital admission for heart failure.

RESULTS - A total of 2147 patients were randomized; 1075 patients allocated to very early invasive evaluation had ICA performed at a median of 4.7 hours after randomization, whereas 1072 patients assigned to standard invasive care had ICA performed 61.6 hours after randomization. Among patients with significant coronary artery disease identified by ICA, coronary revascularization was performed in 88.4% (very early ICA) and 83.1% (standard invasive care) of the patients. Within a median follow-up time of 4.3 (IQR 4.1-4.4) years the primary endpoint occurred in 296 (27.5%) of participants in the very early ICA group and 316 (29.5%) in the standard care group (HR 0.92 [CI95 0.78-1.08]). Among patients with a GRACE risk score >140, a very early invasive treatment strategy improved the primary outcome compared with the standard invasive treatment (HR 0.81 95% CI 0.67-1.01, p-value for interaction = 0.023).

CONCLUSIONS - A strategy of very early invasive coronary evaluation does not improve overall long-term clinical outcome compared with an invasive strategy conducted within 2-3 days in patients with NSTE-ACS. However, in patients with the highest risk, very early invasive therapy improves long-term outcomes.

Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02061891