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Článek

PubMed

Záznam pochází z PubMed

Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial

The Lancet. Neurology. 2024 Sep ; 23 (9) : 883-892. [epub] 20240726

Lancet Neurol
ISSN 1474-4465 | 1474-4422
Zdroj

Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic

Typ dokumentu časopisecké články, randomizované kontrolované studie, multicentrická studie

Perzistentní odkaz https://www.medvik.cz/link/pmid39074480

PubMed 39074480
DOI 10.1016/s1474-4422(24)00278-3
PII: S1474-4422(24)00278-3
Knihovny.cz E-zdroje

MeSH
endovaskulární výkony * metody MeSH
ischemická cévní mozková příhoda * chirurgie terapie MeSH
kvalita života MeSH
lidé středního věku MeSH
lidé MeSH
senioři nad 80 let MeSH
senioři MeSH
trombektomie * metody MeSH
výsledek terapie MeSH
Check Tag
lidé středního věku MeSH
lidé MeSH
mužské pohlaví MeSH
senioři nad 80 let MeSH
senioři MeSH
ženské pohlaví MeSH
Publikační typ
časopisecké články MeSH
multicentrická studie MeSH
randomizované kontrolované studie MeSH

BACKGROUND: Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. METHODS: TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged ≥18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. FINDINGS: We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 8·36 months (IQR 0·02-12·00). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 2·39 [95% CI 1·47-3·90]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (0·7 [IQR 0·4-0·9] vs 0·4 [0·2-0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4-50·8] vs 37·4 [32·4-44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3-48·3] vs 38·8 [31·3-44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 0·70 [95% CI 0·50-0·99]). INTERPRETATION: In patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients. FUNDING: European Union Horizon 2020 Research and Innovation Programme.

Clinic of Neurology Jessenius Faculty of Medicine Comenius University of Bratislava Martin Slovakia

Clinic of Radiology Jessenius Faculty of Medicine Comenius University of Bratislava Martin Slovakia

Department of Medical Imaging St Anne's University Hospital Brno and Faculty of Medicine Masaryk University Brno Czech Republic

Department of Neurology Aarhus University Hospital Department of Neurology Aarhus Denmark

Department of Neurology and Stroke Center Hospital La Paz Institute for Health Research IdiPAZ Madrid Spain

Department of Neurology Charles University Faculty of Medicine Hradec Kralove Czech Republic

Department of Neurology Oslo University Hospital Rikshospitalet Oslo Norway

Department of Neuroradiology Aarhus University Hospital Department of Neurology Aarhus Denmark

Department of Neuroradiology Hôpital Maison Blanche Université Reims Champagne Ardenne Reims France

Department of Neuroradiology Medical University Innsbruck Innsbruck Austria

Department of Neuroradiology Oslo University Hospital Rikshospitalet Oslo Norway

Department of Radiology Charles University Faculty of Medicine Hradec Kralove Czech Republic