Abstract
BACKGROUND AND PURPOSE: There are few randomized trials comparing coiling (with or without stent placement) and flow diversion (FD) for the treatment of wide-neck unruptured intracranial aneurysms. MATERIALS AND METHODS: EVIDENCE was an investigator-led randomized (1:1) trial conducted in 7 French university hospitals. Patients with 7 to 20-mm intradural unruptured intracranial aneurysms with a 4- to 10-mm neck and a "dome/neck" ratio of ≥1 were randomly allocated to coiling with or without adjunctive stent placement or FD alone. The composite primary efficacy outcome was "treatment failure," defined as initial failure to treat the aneurysm; aneurysm rupture or retreatment during follow-up; death or dependency (mRS> 2); or an angiographic residual aneurysm adjudicated by an independent core laboratory at 12 months. The primary hypothesis (revised for slow accrual) was that FD would decrease treatment failures from 35% to 10%, requiring 90 patients. Primary analyses were intent to treat. RESULTS: Among the 91 enrolled patients, four (two in each group) withdrew consent; 87 patients were included in the analysis: 43 in the FD group and 44 in the control group. Most patients had <10 mm (57/87; 65.5%) asymptomatic ophthalmic aneurysms (75/87, 86.2%). A poor primary outcome, ascertainable in 86 patients, was reached in 8/43 patients with FD (18.6%; 95% CI, 9.7%-32.6%) compared with 10/43 coiling patients (23.3%; 95 CI, 13.1%-37.7%) (RR = 0.80; 95% CI, 0.35-1.83; P = .60). Serious adverse events were similar. CONCLUSIONS: For patients with mostly unruptured, wide-neck ophthalmic aneurysms of <10 mm, FD was not superior to coiling with or without stent placement.