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Randomized Controlled Trial
. 2017 Mar;38(3):432-441.
doi: 10.3174/ajnr.A5101. Epub 2017 Jan 12.

Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial

J Raymond  1 , R Klink  2 , M Chagnon  3 , S L Barnwell  4 , A J Evans  5 , J Mocco  6 , B H Hoh  7 , A S Turk  8 , R D Turner  8 , H Desal  9 , D Fiorella  10 , S Bracard  11 , A Weill  12 , F Guilbert  12 , S Lanthier  13 , A J Fox  14 , T E Darsaut  15 , P M White  16 , D Roy  12
Affiliations
Randomized Controlled Trial

Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial

J Raymond et al. AJNR Am J Neuroradiol. 2017 Mar.

Abstract

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.

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Figures

Fig 1.
Fig 1.
Trial profile. Patients screened are not reported because no eligibility logs were required per protocol. Four hundred forty-seven patients in PRET included 250 in PRET-1 and 197 in PRET-2 groups.
Fig 2.
Fig 2.
Subgroup analysis of primary outcome in PRET groups.
See this image and copyright information in PMC

References

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