直接取栓与桥接治疗对急性大血管闭塞性缺血性卒中疗效比较的荟萃分析 Efficacy and Safety of Direct Thrombectomy versus Bridging Therapy for Acute Ischemic Stroke: A Meta-Analysis

目的 比较急性大血管闭塞性缺血性卒中（acute ischemic stroke with large vessel occlusion，AIS-LVO）患者直接取栓治疗（direct endovascular thrombectomy，DEVT）和桥接治疗（bridging therapy，BT）的疗效和安全性。 方法 检索1990年1月1日-2022年7月15日PubMed、Embase和Cochrane图书馆数据库已经发表的英文文献。纳入标准：在符合IVT条件（卒中发作时间≤4.5 h）的AIS-LVO患者中，应用随机临床试验（randomized controlled trial，RCT）或基线匹配分析的前瞻性观察性研究，比较DEVT与BT治疗的有效性和安全性。首要有效性终点为卒中发病90 d神经功能独立（mRS 0～2分），首要安全性终点是全因死亡率，其他终点包括症状性颅内出血（symptomatic intracerebral hemorrhage，sICH）发生率和血管成功再通率（TICI≥2b/3级）。主要有效性的非劣效性界值定义为RD的95%CI下限≥-6.5%。 结果 共6项RCT研究（2334例）和5项前瞻性观察性研究（2947例）纳入荟萃分析。DEVT组2620例（49.6%），BT组2661例（50.4%）。对于首要有效性终点，DEVT的发病90 d神经功能独立性差于BT（44.4% vs. 47.6%），差异有统计学意义（RD -0.03，95%CI -0.06～-0.01）。DEVT组sICH发生率低于BT组（4.3% vs. 5.5%；RD -0.01，95%CI -0.02～-0.00），差异有统计学意义；两组全因死亡率（20.0% vs. 18.8%，RD 0.01，95%CI -0.01～0.03）和血管成功再通率（85.1% vs. 86.4%；RD -0.01，95%CI -0.04～0.01）比较，差异无统计学意义。 结论 对于卒中发病后≤4.5 h的AIS-LVO患者，直接取栓对急性大血管闭塞性缺血性卒中的疗效差于桥接治疗，还需要进一步行RCT研究。 Abstract: Objective To compare the efficacy and safety of direct endovascular thrombectomy (DEVT) and bridging therapy (BT) for acute ischemic stroke (AIS) with large vessel occlusion (LVO). Methods The literature involving the DEVT and BT for AIS-LVO were retrieved in the PubMed, Embase database and Cochrane library database from January 1, 1990 to July 15, 2022. The studies included randomized controlled trials (RCTs) or prospective observational studies enrolling the patients with AIS-LVO who were eligible for intravenous thrombolysis (IVT) (time from stroke onset ≤4.5 h). The efficacy and safety of DEVT and BT were compared. The primary efficacy outcome was 90-day functional independence, defined as a mRS score of 0-2, the primary safety outcome was all-cause mortality, the other endpoints were symptomatic intracranial hemorrhage (sICH), and successful vascular recanalization (defined as TICI 2b/3). The non-inferiority cutoff for primary validity was defined as the lower limit of 95%CI for RD ≥-6.5%. Results Finally, six RCTs (n=2334) and five observational prospective trials (n=2947) were included in the meta-analysis. There were 2620 patients (49.6%) in DEVT group and 2661 (50.4%) in BT group. The primary efficacy endpoint in DEVT group was inferior to that in BT group (44.4% vs. 47.6%, RD -0.03, 95%CI -0.06--0.01). The incidence of sICH in DEVT group was lower than that in BT group (4.3% vs. 5.5%, RD -0.01, 95%CI -0.02--0.00); while there were no statistical differences in all-cause death (20.0% vs. 18.8%, RD 0.01, 95%CI -0.01-0.03), and the rate of successful recanalization (85.1% vs. 86.4%, RD -0.01, 95%CI -0.04-0.01) between the two groups. Conclusions For patients with AIS-LVO within 4.5 hours from stroke onset, DEVT was inferior to BT and more RCTs were needed in the future.