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Flow Diversion versus Coiling with or without Stenting for Unruptured Wide-Neck Intracranial Aneurysms: A Randomized
William Boisseau1, Xavier Combaz2, Olivier Levrier2
1From the Interventional Neuroradiology Department (W.B., S.S., S.E., M.P.), Fondation Adolphe de Rothschild, Paris, Ile de France, France.
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.
