RT Journal Article
SR Electronic
T1 Stent-Assisted Coiling in the Treatment of Unruptured Intracranial Aneurysms: A Randomized Clinical Trial
JF American Journal of Neuroradiology
JO Am. J. Neuroradiol.
FD American Society of Neuroradiology
SP 381
OP 389
DO 10.3174/ajnr.A7815
VO 44
IS 4
A1 Boisseau, W.
A1 Darsaut, T.E.
A1 Fahed, R.
A1 Drake, B.
A1 Lesiuk, H.
A1 Rempel, J.L.
A1 Gentric, J.-C.
A1 Ognard, J.
A1 Nico, L.
A1 Iancu, D.
A1 Roy, D.
A1 Weill, A.
A1 Chagnon, M.
A1 Zehr, J.
A1 Lavoie, P.
A1 Nguyen, T.N.
A1 Raymond, J.
YR 2023
UL http://www.ajnr.org/content/44/4/381.abstract
AB 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.CAcoiling aloneDSMCData and Safety Monitoring CommitteeRRrelative riskSACstent-assisted coilingUIAunruptured intracranial aneurysm