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Randomized Controlled Trial
. 2023 Apr;44(4):381-389.
doi: 10.3174/ajnr.A7815. Epub 2023 Mar 16.

Stent-Assisted Coiling in the Treatment of Unruptured Intracranial Aneurysms: A Randomized Clinical Trial

W Boisseau  1 , T E Darsaut  2 , R Fahed  3 , B Drake  4 , H Lesiuk  4 , J L Rempel  5 , J-C Gentric  6 , J Ognard  6 , L Nico  7 , D Iancu  1 , D Roy  1 , A Weill  1 , M Chagnon  8 , J Zehr  8 , P Lavoie  9 , T N Nguyen  10   11 , J Raymond  12
Affiliations
Randomized Controlled Trial

Stent-Assisted Coiling in the Treatment of Unruptured Intracranial Aneurysms: A Randomized Clinical Trial

W Boisseau et al. AJNR Am J Neuroradiol. 2023 Apr.

Abstract

Background and purpose: Stent-assisted coiling may improve angiographic results of endovascular treatment of unruptured intracranial aneurysms compared with coiling alone, but this has never been shown in a randomized trial.

Materials and methods: The Stenting in the Treatment of Aneurysm Trial was an investigator-led, parallel, randomized (1:1) trial conducted in 4 university hospitals. Patients with intracranial aneurysms at risk of recurrence, defined as large aneurysms (≥10 mm), postcoiling recurrent aneurysms, or small aneurysms with a wide neck (≥4 mm), were randomly allocated to stent-assisted coiling or coiling 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 stent-assisted coiling would decrease treatment failures from 33% to 15%, requiring 200 patients. Primary analyses were intent to treat.

Results: Of 205 patients recruited between 2011 and 2021, ninety-four were allocated to stent-assisted coiling and 111 to coiling alone. The primary outcome, ascertainable in 203 patients, was reached in 28/93 patients allocated to stent-assisted coiling (30.1%; 95% CI, 21.2%-40.6%) compared with 30/110 (27.3%; 95% CI, 19.4%-36.7%) allocated to coiling alone (relative risk = 1.10; 95% CI, 0.7-1.7; P = .66). Poor clinical outcomes (mRS >2) occurred in 8/94 patients allocated to stent-assisted coiling (8.5%; 95% CI, 4.0%-16.6%) compared with 6/111 (5.4%; 95% CI, 2.2%-11.9%) allocated to coiling alone (relative risk = 1.6; 95% CI, 0.6%-4.4%; P = .38).

Conclusions: The STAT trial did not show stent-assisted coiling to be superior to coiling alone for wide-neck, large, or recurrent unruptured aneurysms.

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Figures

FIG 1.
FIG 1.
STAT participant flow CONSORT diagram.
FIG 2.
FIG 2.
Subgroup analysis of the primary outcome at 1 year. ACA indicates anterior cerebral artery.
See this image and copyright information in PMC

References

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