A paradigm shift in the management of acute ischemic stroke (AIS) due to large-vessel occlusion (LVO) occurred after 2015 when 7 randomized controlled trials demonstrated better outcomes using second-generation thrombectomy devices combined with best medical management than did stand-alone intravenous thrombolysis (IVT) with tissue plasminogen activator (tPA). All recently published landmark trials were designed to study the outcome of mechanical thrombectomy (MT); therefore, the majority of the patients enrolled in these trials received intravenous tPA. Currently, initiating IVT before MT is a matter of debate. Recent trials (DIRECT-MT, DEVT) exploring this clinical question showed noninferiority of MT alone compared with the combined treatment. With this uncertainty, the authors aimed to explore real-world data through the latest National Inpatient Sample (NIS) to compare the safety and outcomes of MT alone with bridging IVT and MT in AIS due to LVO in the middle cerebral artery (MCA).

NIS data from 2017 to 2018 were analyzed to compare the outcomes and safety profiles of patients who underwent MT+IVT with those who underwent MT alone.

A total of 2895 patients were included in the final analysis (MT, n = 1669; MT+IVT, n = 1226). The mean National Institutes of Health Stroke Scale score was 16.2 (SD 6.1) in the MT group and 16.6 (SD 5.97) in the MT+IVT group (p = 0.04). With respect to comorbidities, the two groups did not differ in rates of hypertension (p = 0.730), atrial fibrillation/flutter (p = 0.828), and smoking status (p = 0.914). The rate of diabetes mellitus was significantly higher in the MT group (28%) than in the MT+IVT group (22.1%) (p < 0.001). The frequency of intracerebral hemorrhage (ICH) in the MT group was 17.7% (n = 296) and 21.5% (n = 263) in the MT+IVT group (p = 0.012). Intraventricular hemorrhage (p = 0.875), subarachnoid hemorrhage (p = 0.99), and vasospasm (p = 0.976) did not differ significantly between the groups. The primary outcome considered was disability status between the groups; 23.8% of patients in the MT+IVT group had minimal disability versus 18.2% in the MT group (p = 0.001). The risk of progressing to severe disability from minimal disability decreased with the addition of IVT to MT (OR 0.762, 95% CI 0.637–0.912). The adjusted odds ratio for ICH in the MT+IVT group was 1.28 (95% CI 1.043–1.571, p = 0.018) and 2.676 (95% CI 1.259–5.686, p = 0.01) for access-site hemorrhages.

In the analysis of the NIS database, the MT+IVT group had significantly higher rates of minimal disability at the time of hospital discharge versus the MT-alone group, despite a higher rate of ICH. The question of whether to treat patients with MT+IVT rather than MT alone is currently being addressed in ongoing prospective clinical trials (SWIFT-DIRECT [NCT03494920], MR CLEAN–NO IV [ISRCTN80619088], and DIRECT-SAFE [NCT03494920]). The results of these studies will contribute to greater understanding and progressive improvement in outcomes for AIS patients.

2015 年之后发生了由大血管闭塞 (LVO) 引起的急性缺血性卒中 (AIS) 管理的范式转变，当时 7 项随机对照试验表明，使用第二代血栓切除装置结合最佳医疗管理的结果优于独立静脉注射用组织纤溶酶原激活剂 (tPA) 溶栓 (IVT)。所有最近发表的具有里程碑意义的试验都旨在研究机械血栓切除术 (MT) 的结果；因此，参加这些试验的大多数患者接受了静脉 tPA。目前，在 MT 之前启动 IVT 是一个有争议的问题。最近探索这一临床问题的试验（DIRECT-MT、DEVT）显示，与联合治疗相比，单独使用 MT 的非劣效性。带着这种不确定性，

分析了 2017 年至 2018 年的 NIS 数据，以比较接受 MT+IVT 的患者与仅接受 MT 的患者的结果和安全性概况。

最终分析共纳入 2895 名患者（MT，n = 1669；MT+IVT，n = 1226）。MT 组的美国国立卫生研究院卒中量表平均评分为 16.2 (SD 6.1)，MT+IVT 组为 16.6 (SD 5.97) (p = 0.04)。在合并症方面，两组的高血压（p = 0.730）、心房颤动/扑动（p = 0.828）和吸烟状况（p = 0.914）的发生率没有差异。MT 组的糖尿病发病率 (28%) 明显高于 MT+IVT 组 (22.1%) (p < 0.001)。MT 组的脑出血 (ICH) 发生率为 17.7% (n = 296) 和 MT+IVT 组的 21.5% (n = 263) (p = 0.012)。脑室内出血 (p = 0.875)、蛛网膜下腔出血 (p = 0.99) 和血管痉挛 (p = 0.976) 在各组之间没有显着差异。考虑的主要结果是组间的残疾状况；MT+IVT 组 23.8% 的患者有轻微残疾，而 MT 组为 18.2%（p= 0.001)。随着 IVT 与 MT 相结合，从轻度残疾发展为重度残疾的风险降低（OR 0.762，95% CI 0.637–0.912）。MT+IVT 组 ICH 的调整优势比为 1.28（95% CI 1.043-1.571，p = 0.018）和 2.676（95% CI 1.259-5.686，p = 0.01）。

在 NIS 数据库的分析中，尽管 ICH 发生率较高，但 MT+IVT 组在出院时的轻微残疾率显着高于单独 MT 组。目前正在进行的前瞻性临床试验（SWIFT-DIRECT [NCT03494920]、MR CLEAN-NO IV [ISRCTN80619088] 和 DIRECT-SAFE [NCT03494920]）正在解决是否治疗 MT+IVT 患者而不是单独 MT 的问题。这些研究的结果将有助于更好地理解和逐步改善 AIS 患者的预后。