Department of Neuroscience, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain.
Department of Statistics and Operations Research, Barcelona-Tech, Barcelona, Spain.
Lancet Neurol. 2017 May;16(5):369-376. doi: 10.1016/S1474-4422(17)30047-9. Epub 2017 Mar 16.
The REVASCAT trial and other studies have shown that the neurovascular thrombectomy improves outcomes at 90 days post stroke. However, whether the observed benefit is sustained in the long term remains unknown. We report the results of the prespecified 12-month analysis of the REVASCAT trial.
Patients with acute ischaemic stroke who could be treated within 8 h of symptom onset were randomly assigned to medical therapy (including intravenous alteplase when eligible) and neurovascular thrombectomy with Solitaire FR or medical therapy alone. The main secondary outcome measure at 1 year follow-up was disability, measured using the modified Rankin Scale (mRS), ranging from 0 (no symptoms) to 6 (death) with categories 5 (severe disability) and 6 (death) collapsed into one category (severe disability or death), analysed as the distribution of the mRS. Additional prespecified secondary outcome measures included health-related quality of life measured with the EuroQol five dimensions questionnaire (EQ-5D) utility index (ranging from -0·3 to 1, higher values indicate better quality of life), the rate of functional independence (mRS 0-2), and cognitive function measured with the Trail Making Test (reported elsewhere). Treatment allocation was open label but endpoints at 12 months were assessed by masked investigators. The trial was registered at ClinicalTrials.gov, number NCT01692379.
From Nov 24, 2012, to Dec 12, 2014, 206 patients were randomly assigned to medical therapy plus endovascular treatment (n=103) or medical treatment alone (n=103), at four centres in Catalonia, Spain. At 12 months post randomisation, based on 205 of 206 outcomes available at 12 months, thrombectomy reduced disability over the range of the mRS (common adjusted odds ratio [aOR] 1·80, 95% CI 1·09-2·99), and improved functional independence (mRS=0-2; 45 [44%] of 103 patients vs 31 [30%] of 103 patients; aOR 1·86, 95% CI 1·01-3·44). Health-related quality of life was superior in the thrombectomy group (mean EQ-5D utility index score, 0·46 [SD 0·38] in the thrombectomy group vs 0·33 [0·33] in the control group, difference 0·12 [95% CI 0·03-0·22]; p=0·01). 1-year mortality was 23% (24 of 103 patients) in the thrombectomy group versus 24% (25 of 103 patients) in the control group.
At 12 months follow-up, neurovascular thrombectomy reduced post-stroke disability and improved health-related quality of life, indicating sustained benefit. These findings have important clinical and public health implications for evaluating the cost-effectiveness of the intervention in the long term.
Fundació Ictus Malaltia Vascular through an unrestricted grant from Medtronic.
REVASCAT 试验和其他研究表明，神经血管血栓切除术可改善卒中后 90 天的预后。然而，观察到的益处是否能长期持续仍不清楚。我们报告了 REVASCAT 试验预先指定的 12 个月分析结果。
症状发作后 8 小时内可接受治疗的急性缺血性卒中患者被随机分配至药物治疗（包括适合时使用静脉内阿替普酶）加 Solitaire FR 血管内血栓切除术或单独药物治疗。主要次要终点是 1 年随访时的残疾程度，使用改良 Rankin 量表（mRS）进行评估（范围为 0（无症状）至 6（死亡），5 级（严重残疾）和 6 级（死亡）合并为一个类别（严重残疾或死亡），作为 mRS 的分布进行分析）。其他预先指定的次要终点包括使用 EuroQol 五维问卷（EQ-5D）效用指数（范围为-0.3 至 1，较高的值表示较好的生活质量）评估的健康相关生活质量，功能独立性率（mRS 0-2），以及使用追踪测试（ elsewhere 报告）评估的认知功能。治疗分配为开放标签，但 12 个月时的终点由盲法研究者进行评估。该试验在 ClinicalTrials.gov 注册，编号为 NCT01692379。
从 2012 年 11 月 24 日至 2014 年 12 月 12 日，在西班牙加泰罗尼亚的四个中心，206 名患者被随机分配至药物治疗加血管内治疗组（n=103）或药物治疗组（n=103）。在随机分组后 12 个月，基于可获得的 12 个月的 205 个结局，血栓切除术降低了 mRS 范围内的残疾程度（常见调整后的优势比[aOR]1.80，95%CI 1.09-2.99），并改善了功能独立性（mRS=0-2；103 例患者中有 45 例[44%] vs 103 例患者中有 31 例[30%]；aOR 1.86，95%CI 1.01-3.44）。血栓切除术组的健康相关生活质量更优（血栓切除术组平均 EQ-5D 效用指数评分 0.46[标准差 0.38]，对照组为 0.33[0.33]，差值 0.12[95%CI 0.03-0.22]；p=0.01）。血栓切除术组 1 年死亡率为 23%（103 例患者中的 24 例），对照组为 24%（103 例患者中的 25 例）。
在 12 个月的随访中，神经血管血栓切除术降低了卒中后的残疾程度，并改善了健康相关的生活质量，表明持续获益。这些发现对评估长期干预的成本效益具有重要的临床和公共卫生意义。
通过 Medtronic 的一项不受限制的赠款，由 Fundación Ictus Malaltia Vascular 提供。
