Department of Neurology, The First Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, Hunan, China.
Department of Cerebrovascular Diseases, Guangyuan Central Hospital, Guangyuan, Sichuan, China.
BMC Neurol. 2023 Feb 27;23(1):84. doi: 10.1186/s12883-023-03111-y.
Two trials in Chinese population showed that endovascular treatment (EVT) alone was noninferior to alteplase follow by EVT at 90 days. However, results of long-term clinical outcomes remain unknown. We reported the results of prespecified 18-month analysis of the DEVT trail.
We assessed clinical outcomes 18 months after patients were randomly assigned to receive EVT alone or bridging therapy for acute ischemic stroke (AIS). The primary outcome was the proportion of functional independence [modified Rankin scale (mRS), 0-2] at 18 months. Secondary outcomes included all-cause mortality and the quality of life at 18 months as measured by means of a health utility index according to the European Quality of Life 5-Dimension 5-level scale (EQ-5D-5L). Kaplan-Meier event curves were used to investigate the risk of mortality in participants with EVT alone or bridging therapy.
Among 234 patients (EVT alone, n = 116; bridging therapy, n = 118) in the DEVT trial, only 231 (98.7%) patients were extended follow-up to 18 months. A total of 60 (51.7%) patients in the EVT alone achieved functional independence vs 56 (47.5%) patients in the bridging therapy (difference, 4.3%; 1-sided 97.5% CI, - 8.4% to ∞, P for noninferiority =0.014). No significant between-group difference was detected in EQ-5D-5L score (0.81 vs 0.73; difference, 0; 95% CI, 0 to 0.005). The cumulative mortality was 27.6% in the EVT alone and 28.8% in the bridging therapy.
At 18 months follow-up, EVT alone was noninferior to bridging therapy regarding favorable functional outcome in patients with AIS.
Trial was registered on Chinese Clinical Trial Registry (ChiCTR-IOR-17013568) on 27/11/2017.
两项针对中国人的临床试验表明，血管内治疗（EVT）单独治疗 90 天与阿替普酶联合 EVT 治疗非劣效。然而，长期临床结果尚不清楚。我们报告了 DEVT 试验预先设定的 18 个月分析结果。
我们评估了患者随机分配接受 EVT 单独治疗或急性缺血性卒中（AIS）桥接治疗后 18 个月的临床结果。主要结局是 18 个月时功能独立性的比例[改良 Rankin 量表（mRS），0-2]。次要结局包括全因死亡率和 18 个月时的生活质量，采用欧洲生活质量 5 维 5 级量表（EQ-5D-5L）测量健康效用指数。Kaplan-Meier 事件曲线用于研究接受 EVT 单独治疗或桥接治疗的参与者的死亡风险。
在 DEVT 试验中，234 例患者（EVT 单独治疗组 n=116，桥接治疗组 n=118）中，仅 231 例（98.7%）患者延长至 18 个月随访。EVT 单独治疗组 60 例（51.7%）患者实现功能独立性，而桥接治疗组 56 例（47.5%）患者（差异 4.3%；单侧 97.5%CI，-8.4%至∞，非劣效性 P=0.014）。EQ-5D-5L 评分两组间无显著差异（0.81 比 0.73；差异 0；95%CI，0 至 0.005）。EVT 单独治疗组累积死亡率为 27.6%，桥接治疗组为 28.8%。
18 个月随访时，EVT 单独治疗在 AIS 患者中的良好功能结局方面不劣于桥接治疗。
试验于 2017 年 11 月 27 日在中国临床试验注册中心（ChiCTR-IOR-17013568）注册。
