Flow diversion versus coiling ± stenting for unruptured wide-neck intracranial aneurysms: a randomized comparison

Abstract

Background and purpose: There are few randomized trials comparing coiling (with or without stenting) and flow diversion (FD) for the treatment of wide-necked unruptured intracranial aneurysms (UIAs).

Materials and methods: EVIDENCE was an investigator-led randomized (1:1) trial conducted in 7 French university hospitals. Patients with 7-20mm intradural UIAs with a 4-10mm neck and a "dome/neck" ratio ≥1 were randomly allocated to coiling with or without adjunctive stenting 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, 4 (2 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 < 10mm (57/87; 65.5%) asymptomatic ophthalmic aneurysms (75/87, 82.2%). A poor primary outcome, ascertainable in 86 patients, was reached in 8/43 FD patients (18.6%, 95%CI 9.7%-32.6%) as compared to 10/43 coiling patients (23.3%, 95 CI 13.1%-37.7%) (RR = 0.80, 95%CI [0.35-1.83]; p=0.60). Serious adverse events were similar.

Conclusions: For patients with mostly unruptured, wide-necked ophthalmic aneurysms <10mm, FD was not shown superior to coiling with or without stenting.

Abbreviations: FD＝ Flow Diversion; SAC＝Stent-Assisted Coiling; UIAs＝ Unruptured Intracranial Aneurysms.