Endovascular Therapy for Patients With Low NIHSS Scores and Large Vessel Occlusion in the 6- to 24-Hour Window: Analysis of the CLEAR Study

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • João Pedro Marto - , Centro Hospitalar Universitario de Lisboa Central (CHULC) (Author)
  • Muhammad Qureshi - , Boston Medical Center (BMC) (Author)
  • Simon Nagel - , Klinikum Ludwigshafen (Author)
  • Raul G Nogueira - , University of Pittsburgh Medical Center (UPMC) (Author)
  • Hilde Henon - , Université de Lille (Author)
  • Liisa Tomppo - , Helsinki University Hospital (HUS) (Author)
  • Peter Arthur Ringleb - , Helsinki University Hospital (HUS) (Author)
  • Diogo C Haussen - , Grady Health System (Author)
  • Mohamad Abdalkader - , Boston Medical Center (BMC) (Author)
  • Volker Puetz - , Department of Neurology, University Hospital Carl Gustav Carus Dresden (Author)
  • Osama O Zaidat - , Mercy Health, Ohio (Author)
  • Jelle Demeestere - , University Hospitals Leuven (Author)
  • João Nuno Ramos - , Centro Hospitalar Universitario de Lisboa Central (CHULC) (Author)
  • Marc Ribo - , Vall d'Hebron University Hospital (Author)
  • Marta Olive-Gadea - , Vall d'Hebron University Hospital (Author)
  • Mahmoud H Mohammaden - , Grady Health System (Author)
  • Santiago Ortega-Gutierrez - , University of Iowa (Author)
  • Sunil Sheth - , McGovern Medical School (Author)
  • Hiroshi Yamagami - , University of Tsukuba (Author)
  • Anne Dusart - , CHU de Charleroi (Author)
  • Jean Raymond - , Centre Hospitalier de l'Université de Montreal (CHUM) (Author)
  • Francois Caparros - , University Hospital of Lille (Author)
  • Daniel Kaiser - , University Medicine (Faculty of Medicine and University Hospital) (Author)
  • Kanta Tanaka - , National Cerebral and Cardiovascular Center (Author)
  • Pekka Virtanen - , Helsinki University Hospital (HUS) (Author)
  • Ajit S Puri - , University of Massachusetts Medical School (Author)
  • James Ernest Siegler - , The University of Chicago (Author)
  • Syed F Zaidi - , University of Toledo (Author)
  • Mouhammad Aghiad Jumaa - , University of Toledo (Author)
  • Eugene Lin - , Mercy Health, Ohio (Author)
  • Manuel Requena - , Vall d'Hebron University Hospital (Author)
  • Patrik Michel - , University Hospital of Lausanne (CHUV) (Author)
  • Simon Mathias Winzer - , Department of Neurology, University Hospital Carl Gustav Carus Dresden (Author)
  • Piers Klein - , Boston Medical Center (BMC) (Author)
  • Stefania Nannoni - , University of Cambridge (Author)
  • Flavio Bellante - , CHU de Charleroi (Author)
  • Sergio Salazar-Marioni - , McGovern Medical School (Author)
  • Milagros Galecio-Castillo - , University of Iowa (Author)
  • Anke Wouters - , University Hospitals Leuven (Author)
  • Rita Ventura - , Centro Hospitalar Universitario de Lisboa Central (CHULC) (Author)
  • Adnan Mujanovic - , Inselspital University Hospital Bern (Author)
  • Liqi Shu - , Rhode Island Hospital (Author)
  • Alicia C Castonguay - , University of Toledo (Author)
  • Jessica Jesser - , National Center for Tumor Diseases (NCT) Dresden (Author)
  • Hesham E Masoud - , SUNY Upstate Medical University (Author)
  • Johannes Kaesmacher - , Inselspital University Hospital Bern (Author)
  • Wei Hu - , The First Affiliated Hospital of USTC China (Author)
  • Daniel Roy - , Centre Hospitalier de l'Université de Montreal (CHUM) (Author)
  • Shadi Yaghi - , Rhode Island Hospital (Author)
  • Negar Asdaghi - , University of Miami Miller School of Medicine (Author)
  • Davide Strambo - , Inselspital University Hospital Bern (Author)
  • Robin Lemmens - , University Hospitals Leuven (Author)
  • Daniel Strbian - , Helsinki University Hospital (HUS) (Author)
  • Charlotte Cordonnier - , Université de Lille (Author)
  • Markus Möhlenbruch - , University Hospital Heidelberg (Author)
  • Thanh N Nguyen - , Boston Medical Center (BMC) (Author)

Abstract

BACKGROUND AND OBJECTIVES: There is uncertainty about whether patients with an anterior circulation large vessel occlusion (LVO) and a low NIH Stroke Scale (NIHSS) score (≤5) benefit from endovascular therapy (EVT) in the late time window (6-24 hours). We compared the clinical outcomes of these patients receiving EVT with those receiving medical management (MM).

METHODS: The CT for Late Endovascular Reperfusion multinational cohort study was conducted at 66 sites across 10 countries from January 2014 to May 2022. This subanalysis included consecutive patients with late-window stroke due to an anterior circulation LVO, defined as occlusion of the internal carotid artery or proximal middle cerebral artery (M1/M2 segments), and a baseline NIHSS score ≤5 who received EVT or MM alone. The primary end point was a 90-day ordinal shift in the modified Rankin Scale (mRS) score. Secondary outcomes were 90-day excellent outcome (defined as mRS scores 0-1 or return to baseline mRS score in patients with a prestroke mRS score >1) and favorable outcome (defined as mRS scores 0-2 or return to baseline mRS score in patients with prestroke mRS score >2). Safety outcomes were symptomatic intracranial hemorrhage and 90-day mortality. We used ordinal and binary logistic regression models to test for outcome differences.

RESULTS: Among 5,098 patients, 318 patients were included (median [interquartile range] age 67 [56-76] years; 149 [46.9%] were female; baseline NIHSS score was 4 [2-5]). A total of 202 patients (63.5%) received EVT and 116 MM (36.5%). There was no difference in favorable 90-day ordinal mRS score shift (adjusted common odds ratio [OR] 0.77, 95% CI 0.45-1.32), excellent outcome (adjusted OR 0.86, 95% CI 0.49-1.50), or favorable outcome (adjusted OR 0.72, 95% CI 0.35-1.50) in the EVT group compared with MM. Symptomatic intracranial hemorrhage risk (adjusted OR 3.40, 95% CI 0.84-13.73) and mortality at 90 days (adjusted OR 2.44, 95% CI 0.60-10.02) were not statistically different between treatment groups.

DISCUSSION: In patients with an anterior LVO and low NIHSS score in the 6-24-hour time window, there was no statistical difference in disability outcomes or intracranial bleeding risk between patients treated with EVT compared with MM. The retrospective and observational design limits our findings. Ongoing randomized controlled trials will provide further insight.

CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that in adult patients with anterior circulation LVO and low NIHSS score (≤5) presenting in the late time window (6-24 hours), EVT does not improve clinical outcome vs MM.

TRIAL REGISTRATION: This study was registered at clinicaltrials.gov under NCT04096248.

Details

Original languageEnglish
Article numbere213442
JournalNeurology
Volume104
Issue number7
Publication statusPublished - Apr 2025
Peer-reviewedYes

External IDs

Scopus 105000799447
ORCID /0000-0001-5258-0025/work/181860907

Keywords

Keywords

  • Humans, Male, Female, Endovascular Procedures/methods, Aged, Middle Aged, Treatment Outcome, Cohort Studies, Ischemic Stroke/therapy, Severity of Illness Index, Time-to-Treatment, Infarction, Middle Cerebral Artery/diagnostic imaging