PT  - JOURNAL ARTICLE
AU  - Raymond, J.
AU  - Klink, R.
AU  - Chagnon, M.
AU  - Barnwell, S.L.
AU  - Evans, A.J.
AU  - Mocco, J.
AU  - Hoh, B.H.
AU  - Turk, A.S.
AU  - Turner, R.D.
AU  - Desal, H.
AU  - Fiorella, D.
AU  - Bracard, S.
AU  - Weill, A.
AU  - Guilbert, F.
AU  - Lanthier, S.
AU  - Fox, A.J.
AU  - Darsaut, T.E.
AU  - White, P.M.
AU  - Roy, D.
TI  - Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial
AID  - 10.3174/ajnr.A5101
DP  - 2017 Jan 12
TA  - American Journal of Neuroradiology
4099  - http://www.ajnr.org/content/early/2017/01/12/ajnr.A5101.short
4100  - http://www.ajnr.org/content/early/2017/01/12/ajnr.A5101.full
AB  - BACKGROUND AND PURPOSE: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils.MATERIALS AND METHODS: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2).RESULTS: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%–53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%–61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838–2.295; P = .20) and in 49.0% (95% CI, 38.8%–59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%–52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428–1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011).CONCLUSIONS: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.