Abstract

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.

Method

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.

요약

• 소개 : 허혈성 뇌졸중에서 혈전제거술의 효능을 보여주는 초기 연구들은 광범위 경색을 제외한 작은 크기 혹은 중간 크기의 경색 환자들을 대상으로 진행되었다. 최근 2년간 일부 논문들에서 광범위 뇌경색 환자들을 대상으로 혈전제거술의 효능을 보여주었다. 본 논문에서는 광범위 허혈성 뇌졸중 발생 12시간 이내로 내과적 치료만 받은 환자군과 내과적 치료와 혈전제거술을 함께 받은 환자군에서 12개월 후의 기능적 임상 결과를 비교하는 무작위 임상연구이다.

  
  

• 방법 : 허혈성 뇌졸중이 발생한 만18세 이상의 성인 환자를 대상으로 시행된 무작위, 다기관 임상연구이다. 내과적치료를 단독으로 받는 환자군과 내과적치료와 혈전제거술을 함께 받는 환자군이 1:1로 무작위 배정되었고, 치료 90일 후와 12개월 후의 임상 결과를 비교하였다.

  
  

• 결과 : 혈전제거술을 함께 받은 환자군이 내과적 치료 단독으로 받은 환자군에 비해 치료 12개월 이후에 더 좋은 기능적 결과, 삶의 질, 생존율을 보였다.

  
  

• 결론 및 의의 : 광범위 뇌경색 환자에서도 내과적 치료와 혈전제거술을 함께 받는 것이 환자의 기능적 회복에 도움을 주며, 삶의 질과 생존율 측면에도 이득이 있다. 본 연구는 광범위 뇌경색 환자의 혈전제거술 시 기능적 회복에 대한 새로운 정보를 제공한다는 면에서 의의가 있다.

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