LB-014 Final results of the ruptured aneurysms treated with hydrogel coils (RAGE) study: a multicenter North American study of 771 patients
Notice bibliographique
Résumé
Endovascular embolization of intracranial aneurysms with second-generation hydrogel coils lowers the risk of recurrence when compared to bare platinum coils, as demonstrated in the randomized controlled trial, HEAT. However, the proportion of ruptured aneurysms in existing studies is limited. The RAGE study is currently the largest prospective, single-arm, core lab adjudicated, multicenter, post-market study focusing exclusively on assessing the safety and effectiveness of HydroCoil Embolic System coils in the ruptured intracranial aneurysm population. Materials and Methods Subjects aged 18 to 80 years were eligible for enrollment if they had a previously untreated, ruptured saccular intracranial aneurysm between 2 and 15 mm in diameter, suitable for embolization with hydrogel coils. Inclusion criteria also required a Hunt and Hess score ≤III. Coiling was performed using any combination of second-generation hydrogel coils (HydroFrameTM, HydroFillTM, HydroSoftTM, HydroSoftTM 3D), with a minimum collective length of 90% of the total coil length used to treat the aneurysm. Study subjects were followed up clinically at 30 days and 18 months post-procedure with angiographic imaging collected at the 18-month visit. The primary efficacy endpoint was adequate angiographic occlusion at 18 ± 6 months without rebleed of the target aneurysm or retreatment secondary to aneurysm recurrence. The primary safety endpoint was procedure- or disease-related death or major stroke within 30 days of treatment or major ipsilateral stroke, neurological death or rebleeding from the target aneurysm within 18 months of treatment. Secondary outcomes included rebleed rate, retreatment rate, and clinical outcome. Rebleeds and other safety events were assessed by an independent clinical events adjudicator and an independent core lab adjudicated the angiographic outcomes. Results From November 2017 through September 2022, 771 subjects (mean age 53.8 years, 27.8% female) were enrolled across 43 sites in the US and two in Canada. Mean aneurysm size was 5.6 mm (range: 2-15mm) and the most common aneurysm locations were ACom (34%) and PCom (30%). 85.4% (455/533) of subjects had adequate angiographic occlusion at the 18-month visit. 76% (405/533) of subjects met the primary effectiveness endpoint of adequate angiographic occlusion at 18-month visit without rebleed of the target aneurysm or retreatment secondary to aneurysm recurrence. 6.1% (47/771) of subjects experienced a composite primary safety outcome event. Overall mortality rate was 4.8% (37/771) and the mRS score at 18 months was 0-2 in 87.5% (503/575) of subjects. Rebleed and retreatment rates at 18 months were 0.4% (3/771) and 13% (100/771) respectively, with retreatment due to recurrence within 18 months occurring in 10.1% (78/771) of subjects. Conclusion The RAGE study demonstrates that second-generation hydrogel coils are a safe and effective treatment option for ruptured intracranial aneurysms, with strong adequate angiographic occlusion rates (85.4%), exceptionally low rebleed rates (0.4%) and favorable neurologic outcomes (mRS 0-2 in 81.5%) at 18 months. As the largest prospective post-market study focused exclusively on this high-risk population, RAGE provides important long-term data that reinforces the clinical value of hydrogel coils in the management of ruptured aneurysms. Disclosures D. Fiorella: 1; C; Microvention/Teruma. 2; C; Microvention/Terumo. A. Arthur: 1; C; Microvention/Terumo. 2; C; Microvention/Terumo.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».