Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center (UPMC) Stroke Institute, University of Pittsburgh School of Medicine, PA (R.G.N.).
Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden (T.A.).
Stroke. 2024 Dec;55(12):2804-2814. doi: 10.1161/STROKEAHA.124.047324. Epub 2024 Nov 19.
The EXCELLENT registry aimed to evaluate the effectiveness of the EMBOTRAP Revascularization Device in an all-comer population in a real-world setting, with a focus on the composition of retrieved clots.
EXCELLENT is a prospective, global registry of patients with acute ischemic stroke treated with EMBOTRAP as the first-line mechanical thrombectomy device conducted at 34 sites (25 sites contributing clot) from September 2018 to March 2021, utilizing core imaging and central histology laboratories blinded to clinical data, independent 90-day modified Rankin Scale assessment and Clinical Events Committee.
After screening 3799 patients, a total of 997 subjects (mean age, 70.0±14.2 years; 51.8% women; 19.7% non-White) were included. The first-pass modified Treatment in Cerebral Infarction (mTICI) ≥2b rate was 64.5% (623/966), first-pass mTICI ≥2c was 39.1% (378/966), and final mTICI ≥2b was 94.5% (931/985). A total of 427/912 (46.8%) patients achieved a 90-day modified Rankin Scale of 0 to 2 or ≤baseline. Embolization to a new territory occurred in 0.2% (2/984), and symptomatic intracranial hemorrhage at 24 hours in 1.6% (16/997). The 90-day mortality was 19.1% (175/918). Device- and/or procedure-related serious adverse events occurred in 5.9% (54/912) through 90 days. The mean RBC percentage of retrieved clots was 45.62±21.372. Among patients who achieved mTICI ≥2b with the first pass, 15.7% (52/331) and 9.7% (32/331), respectively, had RBC-poor (<25%) and RBC-rich (>75%) clots. Patients with no clot retrieved in any procedural pass had a lower percentage of hyperdense or susceptibility vessel sign on baseline imaging (58.9% versus 74.7%; <0.001), pointing to a potential preprocedure indicator of challenging clot.
The EXCELLENT registry informs real-world practices in mechanical thrombectomy and sheds light on the range of clots effectively retrieved by current technology. This is the first report of detailed patient characteristics where mechanical thrombectomy maneuvers failed to remove any clot material. Although the composition of nonretrievable clots cannot be assessed histologically, the results support the notion that no retrieval may be correlated with imaging findings suggesting clots lower in RBC.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03685578.
EXCELLENT 注册研究旨在评估 EMBOTRAP 再通装置在真实世界环境中对所有患者的有效性，重点关注回收血栓的成分。
EXCELLENT 是一项前瞻性、全球性的注册研究，纳入了 2018 年 9 月至 2021 年 3 月期间 34 个中心（25 个中心提供血栓）使用 EMBOTRAP 作为一线机械取栓装置治疗的急性缺血性卒中患者，利用核心影像学和中心组织学实验室进行盲法评估，独立进行 90 天改良 Rankin 量表（mRS）评估和临床事件委员会评估。
在筛选了 3799 名患者后，共纳入了 997 例患者（平均年龄 70.0±14.2 岁；51.8%为女性；19.7%为非白人）。首次通过改良治疗后脑梗死（mTICI）评分≥2b 的比例为 64.5%（623/966），首次通过 mTICI 评分≥2c 的比例为 39.1%（378/966），最终 mTICI 评分≥2b 的比例为 94.5%（931/985）。共有 427/912（46.8%）例患者在 90 天时 mRS 评分达到 0-2 分或与基线水平相同。有 0.2%（2/984）的患者出现栓塞到新的供血区，1.6%（16/997）的患者在 24 小时内发生症状性颅内出血。90 天死亡率为 19.1%（175/918）。在 90 天内，与设备和/或操作相关的严重不良事件发生率为 5.9%（54/912）。在首次通过即达到 mTICI≥2b 的患者中，分别有 15.7%（52/331）和 9.7%（32/331）的患者血栓中红细胞比例低（＜25%）和高（＞75%）。在任何手术通路上均未回收血栓的患者，其基线影像上存在高密度或易损血管征的比例较低（58.9% vs. 74.7%；<0.001），这可能是提示血栓难以取出的术前指标。
EXCELLENT 注册研究为机械取栓提供了真实世界的实践信息，并阐明了当前技术可有效回收的血栓范围。这是首次报告详细的患者特征，其中机械取栓操作未能取出任何血栓物质。尽管无法对不可回收的血栓进行组织学评估，但结果支持这样一种观点，即无血栓回收可能与提示血栓中红细胞比例较低的影像学表现相关。
