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  3. Changes in Infarct Volume and Cerebral Edema After Mechanical Thrombectomy in Patients With Stroke Randomized to ApTOLL or Placebo: A Secondary Analysis of APRIL Trial

Changes in Infarct Volume and Cerebral Edema After Mechanical Thrombectomy in Patients With Stroke Randomized to ApTOLL or Placebo: A Secondary Analysis of APRIL Trial

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Hernández-Pérez M.
  • Valls-Carbó A.
  • Hernández-Jiménez M.
  • Molina C.
  • Mora J.V.
  • Castellanos M.
  • García-Madrona S.
  • Moniche F.
  • Terceño M.
  • Cardona P.
  • Arenillas J.F.
  • Calleja P.
  • Henon H.
  • Calviere L.
  • Mazighi M.
  • Olivot J.M.
  • Liebeskind D.S.
  • Ribo M.

Grupos

Abstract

BACKGROUND: APRIL (A Double-Blind, Placebo-Controlled, Randomized, Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke), a randomized placebo-controlled phase Ib/IIa trial, showed safety and reduced mortality and disability at 90 days of ApTOLL 0.2 mg/kg in combination with endovascular treatment in patients with acute large vessel occlusion within a 6-hour window. We studied the effect of ApTOLL against placebo on final infarct volume, infarct growth, and cerebral edema. METHODS: Post hoc analysis of a trial was conducted between 2020 and 2022 in Spain and France. Patients allocated to ApTOLL doses of 0.05 and 0.2 mg/kg and placebo were selected. The early infarct growth rate was defined as admission relative cerebral blood flow <30% volume/time elapsed from last-known well to imaging, considering fast progressors when >10 mL/h. An imaging core laboratory evaluated final infarct volume and cerebral edema on fluid-attenuated inversion recovery or noncontrast computed tomography at 72 hours if fluid-attenuated inversion recovery was not available. Cerebral edema was evaluated according to the SITS-MOST (Safe Implementation of Thrombolysis in Stroke-Monitoring Study) edema scale (cerebral edema degree [CED]; less severe: CED1; more severe: CED2; and with midline shift: CED3). Infarct growth was calculated as the final infarct volume: relative cerebral blood flow <30% volume at admission. Associations were studied through linear or ordinal models adjusted by prespecified variables. Admission relative cerebral blood flow <30% volume, fast recruitment, and final expanded Thrombolysis in Cerebral Infarction, among others, were examined for interaction with ApTOLL on final infarct volume and CED. RESULTS: A total of 136 of 139 patients had sufficient radiological data. Median admission relative cerebral blood flow <30% was 18 mL, and median final infarct volume was 36.53 mL. Edema grade was CED1 in 45%, CED2 in 34%, and CED3 in 21% patients. Compared with placebo, ApTOLL 0.2 mg/kg was independently associated with a lower final infarct volume (relative reduction, –45.2% [95% CI, -65% to -15%]), a lower infarct growth (61.51% [95% CI, -79% to -29%]), and a lower edema grade (common odds ratio, 0.38 [95% CI, 0.15–0.96]). No associations were found for ApTOLL 0.05 mg/kg. The study of interactions showed a greater benefit of ApTOLL 0.2 mg/kg among patients with larger core volume at admission, fast progressors, and patients achieving incomplete reperfusion (expanded Thrombolysis in Cerebral Infarction <2b). CONCLUSIONS: ApTOLL 0.2 mg/kg in combination with mechanical thrombectomy significantly reduced final infarct volume, infarct growth, and cerebral edema at 72 hours. ApTOLL seemed to be more effective under conditions prone to infarct growth. © 2025 American Heart Association, Inc.

Datos de la publicación

ISSN/ISSNe:
0039-2499, 1524-4628

STROKE  LIPPINCOTT WILLIAMS & WILKINS

Tipo:
Article
Páginas:
2422-2430
PubMed:
40677233
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
3,245 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • Aged; Aged, 80 and over; Brain Edema; Double-Blind Method; Female; Humans; Ischemic Stroke; Male; Middle Aged; Stroke; Thrombectomy; aptamer; aptoll; placebo; toll like receptor antagonist; unclassified drug; aged; Article; brain blood flow; brain edema; brain infarction; cerebrovascular accident; computer assisted tomography; controlled study; core laboratory; double blind procedure; female; France; growth rate; hospital admission; human; infarct volume; major clinical study; male; mechanical thrombectomy; phase 1 clinical trial; phase 2 clinical trial; post hoc analysis; randomized controlled trial; secondary analysis; Spain; cerebrovascular accident; clinical trial; diagnostic imaging; etiology; ischemic stroke; middle aged; multicenter study; procedures; therapy; thrombectomy; very elderly

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