Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial
Sprache des Titels:
Englisch
Original Kurzfassung:
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.
Forschungs-