Patients Prone to Recurrence after Endovascular Treatment: Periprocedural Results of the PRET Randomized Trial on Large and Recurrent Aneurysms

Raymond, Jean; Klink, Ruby; Chagnon, Miguel; Barnwell, Stanley L.; Evans, Avery J.; Mocco, J; Hoh, Brian L.; Turk, Aquilla S; Turner, Raymond D; Desal, Hubert; Fiorella, David; Bracard, Serge; Weill, Alain; Guilbert, F; Roy, Daniel

doi:10.3174/ajnr.a4035

Cited by 23 publications

(29 citation statements)

References 25 publications

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“…20 Twenty-seven additional adverse events (14 platinum, 13 hydrogel) occurred after 1 month. Eighteen were serious (7 platinum, 11 hydrogel).…”

Section: Resultsmentioning

confidence: 99%

“…20 There were few delayed adverse events after 1 month. Treatment-related morbidity (4.0%) and mortality (0.7%) were relatively low for both groups.…”

Section: Discussionmentioning

confidence: 99%

“…Details of data collection are given elsewhere. 20 Briefly, following registration, intervention, and discharge data collection, clinical follow-up data were recorded at 1, 6, and 18 months and angiographic follow-up imaging was performed at 6 and 18 months. Adverse events and additional interventions on the target aneurysm were reported at any time during the trial.…”

Section: Data Collectionmentioning

confidence: 99%

“…Similar periprocedural (30 days) outcomes were reported for hydrogel and platinum coiling. 20 We now report the primary outcome of the trial: The primary hypothesis was that the use of hydrogel coils would decrease the proportion of residual or recurrent aneurysms from 50% to 30% (range from 50%-40% to 30%-21%) at 18 months compared with bare platinum coils.…”

mentioning

confidence: 99%

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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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“…20 Twenty-seven additional adverse events (14 platinum, 13 hydrogel) occurred after 1 month. Eighteen were serious (7 platinum, 11 hydrogel).…”

Section: Resultsmentioning

confidence: 99%

“…20 There were few delayed adverse events after 1 month. Treatment-related morbidity (4.0%) and mortality (0.7%) were relatively low for both groups.…”

Section: Discussionmentioning

confidence: 99%

Section: Data Collectionmentioning

confidence: 99%

mentioning

confidence: 99%

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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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“…However, large and giant aneurysms remain difficult to treat by using assist techniques and bioactive coils, 1,2 possibly because the requisite coil-packing attenuation is often not achieved. We recently developed a "maze-making and solving" technique to occlude these large/giant aneurysms by achieving high packing attenuation.…”

mentioning

confidence: 99%

The Maze-Making and Solving Technique for Coil Embolization of Large and Giant Aneurysms

Ohta

Nakahara

Ishibashi

et al. 2014

AJNR Am J Neuroradiol

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BACKGROUND AND PURPOSE: Despite major progress in treating aneurysms by coil embolization, the complete occlusion of aneurysms of Ͼ10 mm in diameter (large/giant aneurysms) remains challenging. We present a novel endovascular treatment method for large and giant cerebral aneurysms called the "maze-making and solving" technique and compare the short-term follow-up results of this technique with those of conventional coil embolization.

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Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable

Volovici,

Verploegh,

Satoer

et al. 2023

JAMA Netw Open

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ImportanceTesting new medical devices or procedures in terms of safety, effectiveness, and durability should follow the strictest methodological rigor before implementation.ObjectivesTo review and analyze studies investigating devices and procedures used in intracranial aneurysm (IA) treatment for methods and completeness of reporting and to compare the results of studies with positive, uncertain, and negative conclusions.Data SourcesEmbase, MEDLINE, Web of Science, and The Cochrane Central Register of Clinical Trials were searched for studies on IA treatment published between January 1, 1995, and the October 1, 2022. Grey literature was retrieved from Google Scholar.Study SelectionAll studies making any kind of claims of safety, effectiveness, or durability in the field of IA treatment were included.Data Extraction and SynthesisUsing a predefined data dictionary and analysis plan, variables ranging from patient and aneurysm characteristics to the results of treatment were extracted, as were details pertaining to study methods and completeness of reporting. Extraction was performed by 10 independent reviewers. A blinded academic neuro-linguist without involvement in IA research evaluated the conclusion of each study as either positive, uncertain, or negative. The study followed Preferring Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Main Outcomes and MeasuresThe incidence of domain-specific outcomes between studies with positive, uncertain, or negative conclusions regarding safety, effectiveness, or durability were compared. The number of studies that provided a definition of safety, effectiveness, or durability and the incidence of incomplete reporting of domain-specific outcomes were evaluated.ResultsOverall, 12 954 studies were screened, and 1356 studies were included, comprising a total of 410 993 treated patients. There was no difference in the proportion of patients with poor outcome or in-hospital mortality between studies claiming a technique was safe, uncertain, or not safe. Similarly, there was no difference in the proportion of IAs completely occluded at last follow-up between studies claiming a technique was effective, uncertain, or noneffective. Less than 2% of studies provided any definition of safety, effectiveness, or durability, and only 1 of the 1356 studies provided a threshold under which the technique would be considered unsafe. Incomplete reporting was found in 546 reports (40%).Conclusions and RelevanceIn this systematic review and meta-analysis of IA treatment literature, studies claiming safety, effectiveness, or durability of IA treatment had methodological flaws and incomplete reporting of relevant outcomes supporting these claims.

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Patients Prone to Recurrence after Endovascular Treatment: Periprocedural Results of the PRET Randomized Trial on Large and Recurrent Aneurysms

Cited by 23 publications

References 25 publications

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

The Maze-Making and Solving Technique for Coil Embolization of Large and Giant Aneurysms

Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable

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