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. 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 , , and is completed. 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] 0·4 [0·2–0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35–70] 30 [5–60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4–50·8] 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] 38·8 [31·3–44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 15 [42%] of 36) and depression (18 [31%] 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]). 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. European Union Horizon 2020 Research and Innovation Programme.

中文翻译：

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血管内血栓切除术治疗伴有大面积梗塞的急性缺血性卒中 (TENSION)：多中心、开放标签、随机试验的 12 个月结果


显示血管内血栓切除术治疗大面积梗死卒中的益处的长期数据很少。 TENSION 试验显示了血管内血栓切除术治疗缺血性中风和大面积梗塞患者 90 天的安全性和有效性。我们的目的是调查参加 TENSION 试验的患者在 12 个月内接受血管内血栓切除术的安全性和有效性。 TENSION 是一项开放标签、盲法终点随机试验，在欧洲 40 家医院和加拿大一家医院进行。我们纳入了因前循环大血管闭塞而患有急性缺血性卒中且有大面积梗塞的患者（年龄≥18岁），根据阿尔伯塔卒中计划早期计算机断层扫描评分（ASPECTS）的标准评分为 3-5 分。护理中风成像。我们随机分配患者 (1:1) 接受血管内血栓切除术和药物治疗或仅在中风发作后 12 小时内接受药物治疗。主要结果是 90 天时整个改良 Rankin 量表范围的功能结果。在这里，我们报告了针对功能结果（使用简化的改良Rankin量表问卷）、生活质量（使用患者报告结果测量信息系统10项[PROMIS-10]和EQ- 5D 问卷）、中风后焦虑和抑郁（使用患者健康问卷 4 [PHQ-4]）以及总生存期。在意向治疗人群中评估结果（生存除外）；生存分析基于所接受的治疗。该试验已在 、 、 注册，并已完成。我们在2018年7月17日至2023年2月21日期间入组了患者，当时试验因疗效而提前停止。 253 名患者被随机分配，其中 125 名 (49%) 接受血管内血栓切除术，128 名 (51%) 接受仅药物治疗。中位随访时间为 8·36 个月（IQR 0·02–12·00）。血管内血栓切除术与改良Rankin量表的评分分布向12个月时更好的功能结果的转变相关（调整后的共同比值比2·39 [95% CI 1·47–3·90]）。与仅接受药物治疗相比，血管内血栓切除术还与更好的生活质量相关，正如 EQ-5D 问卷指数的中位数分数所反映的那样 (0·7 [IQR 0·4–0·9] 0·4 [0·2 –0·7]）、EQ-5D 问卷视觉模拟量表健康状况得分中位数（50 [IQR 35–70] 30 [5–60]）以及 PROMIS-10 问卷全球身体健康得分中位数（ T 分数 39·8 [IQR 37·4–50·8] 37·4 [32·4–44·9])；尽管没有足够的证据表明 PROMIS-10 的全球心理健康评分 (41·1 [IQR 36·3–48·3] 38·8 [31·3–44·7]) 或在 PHQ-4 上报告焦虑的患者数量（58 例中的 13 例 [22%]，36 例中的 15 例 [42%]）和抑郁症（18 例 [31%] 18 例 [50%]）。与单纯药物治疗相比，血管内血栓切除术组的总生存率略好（调整后的风险比为 0·70 [95% CI 0·50–0·99]）。对于大血管闭塞并已形成大面积梗死的急性缺血性卒中患者，与仅接受药物治疗相比，卒中后 12 个月进行血管内血栓切除术可带来更好的功能结果、生活质量和总体生存率。这些研究结果表明，血管内血栓切除术对缺血性中风和大面积梗塞患者的益处是长期持续的，并支持在这些患者中使用血管内血栓切除术。 欧盟地平线 2020 研究与创新计划。