Cerecyte Coil Trial

Molyneux, Andrew; Clarke, A. M.; Sneade, Mary; Mehta, Ziyah; Coley, Stuart C.; Roy, Daniel; Kallmes, David F.; Fox, Allan J.

doi:10.1161/strokeaha.112.657254

Cited by 110 publications

(47 citation statements)

References 15 publications

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“…The Cerecyte trial reported a combined success rate, defined as stable angiographically visible occlusion, stable neck remnant, or improved occlusion of the aneurysm, of 57% (245/433) for ruptured and unruptured aneurysms at the 6-month follow-up. 7 The hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS) trial reported a major angiographically confirmed recurrence in 24%-33% of patients at the 18-month follow-up in a per-protocol analysis.…”

Section: Discussionmentioning

confidence: 99%

The Barrow Ruptured Aneurysm Trial: 6-year results

Spetzler

McDougall

Zabramski

et al. 2015

JNS

360

176

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obJect The authors report the 6-year results of the Barrow Ruptured Aneurysm Trial (BRAT). This ongoing randomized trial, with the final goal of a 10-year follow-up, compares the safety and efficacy of surgical clip occlusion and endovascular coil embolization in patients presenting with subarachnoid hemorrhage (SAH) from a ruptured aneurysm. The 1- and 3-year results of this trial have been previously reported. methods In total, 500 patients with an SAH met the entry criteria and were enrolled in the study. Of these patients, 471 were randomly assigned to the treatments: 238 to surgical clipping and 233 to endovascular coiling. Six patients who died before treatment and 57 patients with nonaneurysmal SAHs were excluded, leaving a total of 408 patients who underwent clipping (209 assigned) or coiling (199 assigned). Whether to treat patients within the assigned group or to cross over patients to the other group was at the discretion of the treating physician; 38% (75/199) of the patients assigned to coiling were crossed over to clipping and 1.9% (4/209) assigned to clipping were crossed over to coiling. The outcome data were collected by a dedicated nurse practitioner. The primary outcome analysis was based on the assigned treatment group; poor outcome was defined as a modified Rankin Scale (mRS) score > 2 and was independently adjudicated. Six years after randomization, 336 (82%) of 408 patients who had been treated were available for examination. results On the basis of an mRS score of > 2, and similar to the results at the 3-year follow-up, no significant difference in outcomes (p = 0.24) was detected between the 2 treatment groups. Complete aneurysm obliteration at 6 years was achieved in 96% (111/116) of the clipping group and in 48% (23/48) of the coiling group (p < 0.0001). In the period between the 3- and 6-year follow-ups, 3 additional patients assigned to coiling and none assigned to clipping received retreatment, for overall retreatment rates of 4.6% (13/280) for clipping and 16.4% (21/128) for coiling (p < 0.0001). When aneurysm location was considered, the 6-year results continued to match the previously reported results, with no difference in outcome for anterior circulation aneurysms at most time points. Of the anterior circulation aneurysms assigned to coiling treatment, 42% (70/168) were crossed over to clipping treatment. The outcomes for posterior circulation aneurysms continued to favor coiling. The randomization process was unexpectedly skewed, with 18 of 21 treated aneurysms of the posterior inferior cerebellar artery (PICA) being assigned to clipping, but even when PICA aneurysms were removed from the analysis, outcomes for the posterior circulation aneurysms still favored coiling. coNclusioNs Although BRAT was statistically underpowered to detect small differences, these results suggest little difference in outcome between the 2 treatments for anterior circulation aneurysms. This was not the case for the posterior circulation aneurysms, where coil embolization appeared to provide a sustai...

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Section: Discussionmentioning

confidence: 99%

The Barrow Ruptured Aneurysm Trial: 6-year results

Spetzler

McDougall

Zabramski

et al. 2015

JNS

360

176

View full text Add to dashboard Cite

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“…15 Recurrent aneurysms after platinum coiling are at high risk of re-recurring when retreated, but these patients were excluded from all published randomized trials. 8,14,[16][17][18] The Patients Prone to Recurrence After Endovascular Treatment (PRET) study was designed in 2007 to offer an alternative to platinum coiling in patients previously shown to be at high risk of recurrence: patients with large (Ն10 mm) or recurrent aneurysms after coiling. The trial protocol was published in 2008.…”

mentioning

confidence: 99%

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

Raymond

Klink

Chagnon

et al. 2017

AJNR Am J Neuroradiol

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“…1 Clinical trials for other modified coils, such as the Matrix (Stryker, Kalamazoo, Michigan) and Cerecyte coils, failed to show any significant benefit for polyglycolic acid/polyglycolic/polylactic acid-modified versus bare platinum coils. 11,25 Our data suggest that hydrogel-modified coils are more beneficial in certain subsets of patients and aneurysms; recurrence rates were reduced 17%-18% in patients with an aneurysm with a small D/N or an irregularly shaped aneurysm. Our study had several limitations.…”

Section: Discussionmentioning

confidence: 76%