Departments of Endovascular Neurosurgery and Stroke, St Vincent Mercy Medical Center, Toledo, Ohio, USA.
Neuroscience & Stroke Center, Mercy Health St Vincent Hospital, Toledo, OH, USA.
J Neurointerv Surg. 2018 Jun;10(6):516-524. doi: 10.1136/neurintsurg-2017-013328. Epub 2017 Sep 29.
Recent randomized clinical trials (RCTs) demonstrated the efficacy of mechanical thrombectomy using stent-retrievers in patients with acute ischemic stroke (AIS) with large vessel occlusions; however, it remains unclear if these results translate to a real-world setting. The TREVO Stent-Retriever Acute Stroke (TRACK) multicenter Registry aimed to evaluate the use of the Trevo device in everyday clinical practice.
Twenty-three centers enrolled consecutive AIS patients treated from March 2013 through August 2015 with the Trevo device. The primary outcome was defined as achieving a Thrombolysis in Cerebral Infarction (TICI) score of ≥2b. Secondary outcomes included 90-day modified Rankin Scale (mRS), mortality, and symptomatic intracranial hemorrhage (sICH).
A total of 634patients were included. Mean age was 66.1±14.8 years and mean baseline NIH Stroke Scale (NIHSS) score was 17.4±6.7; 86.7% had an anterior circulation occlusion. Mean time from symptom onset to puncture and time to revascularization were 363.1±264.5 min and 78.8±49.6 min, respectively. 80.3% achieved TICI ≥2b. 90-day mRS ≤2 was achieved in 47.9%, compared with 51.4% when restricting the analysis to the anterior circulation and within 6 hours (similar to recent AHA/ASA guidelines), and 54.3% for those who achieved complete revascularization. The 90-day mortality rate was 19.8%. Independent predictors of clinical outcome included age, baseline NIHSS, use of balloon guide catheter, revascularization, and sICH.
The TRACK Registry results demonstrate the generalizability of the recent thrombectomy RCTs in real-world clinical practice. No differences in clinical and angiographic outcomes were shown between patients treated within the AHA/ASA guidelines and those treated outside the recommendations.
最近的随机临床试验(RCTs)表明,在伴有大血管闭塞的急性缺血性脑卒中(AIS)患者中,使用支架取栓器进行机械血栓切除术是有效的;然而,这些结果是否适用于真实世界的情况仍不清楚。TREVO 支架取栓器急性脑卒中(TRACK)多中心注册研究旨在评估 Trevo 装置在日常临床实践中的应用。
23 个中心纳入了 2013 年 3 月至 2015 年 8 月期间使用 Trevo 装置治疗的连续 AIS 患者。主要结局定义为达到血栓溶解率(TICI)评分≥2b。次要结局包括 90 天改良 Rankin 量表(mRS)评分、死亡率和症状性颅内出血(sICH)。
共纳入 634 例患者。平均年龄为 66.1±14.8 岁,平均基线 NIH 卒中量表(NIHSS)评分为 17.4±6.7;86.7%的患者为前循环闭塞。从症状发作到穿刺的平均时间和再通时间分别为 363.1±264.5min 和 78.8±49.6min。80.3%的患者达到 TICI≥2b。90 天 mRS≤2 的比例为 47.9%,与前循环且在 6 小时内(与最近的 AHA/ASA 指南相似)的分析相比为 51.4%,完全再通的患者为 54.3%。90 天死亡率为 19.8%。临床结局的独立预测因素包括年龄、基线 NIHSS、使用球囊导引导管、再通和 sICH。
TRACK 注册研究结果表明,最近的取栓 RCT 结果在真实世界的临床实践中具有普遍性。在 AHA/ASA 指南内和指南外治疗的患者之间,临床和血管造影结局没有差异。