Abstract：
BACKGROUND: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment.
METHODS: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator.
RESULTS: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2.
CONCLUSIONS: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times.
METHODS: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator.
RESULTS: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2.
CONCLUSIONS: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times.
摘要：
背景：机械血栓切除术（MT）是大血管闭塞（LVO）的急性缺血性卒中（AIS）患者的标准治疗方法。SOFAST研究收集了6号法国SOFIAFlowPlus抽吸导管（SOFIA6F）作为一线治疗时的安全性和有效性的临床证据。
方法：这是一个前瞻性的，多中心调查以评估用于一线抽吸的SOFIA6F的安全性和有效性。入选前循环LVO卒中患者。主要终点是最终改良的脑梗死溶栓（mTICI）≥2b率。次要终点包括首过和一线mTICI≥2b率，从动脉切开术到血块接触的次数和mTICI≥2b，90天改良Rankin量表（mRS）≤2。一线和最终mTICI评分由独立的成像核心实验室裁定。安全性事件由独立的临床事件裁决者进行评估。
结果：从2020年7月至2022年6月，在12个中心共招募了108名患者。年龄中位数是67岁,美国国立卫生研究院卒中量表(NIHSS)的中位数为15.5,56.5%的患者接受了静脉溶栓.在程序结束时,97.2%,85.2%,55.6%的患者mTICI≥2b，≥2c,和分别为3。使用SOFIA6F一线抽吸，87.0%,79.6%,52.8%的mTICI≥2b，≥2c,和分别为3。第一次通过后，75.0%,70.4%,50.9%的mTICI≥2b，≥2c,和分别为3。从动脉切开术到凝块接触和成功血运重建的中位时间为12和17分钟，分别。90天,66.7%的患者mRS≤2。
结论：SOFIA6F一线抽吸术安全有效，血运重建率高，手术时间短。
方法：这是一个前瞻性的，多中心调查以评估用于一线抽吸的SOFIA6F的安全性和有效性。入选前循环LVO卒中患者。主要终点是最终改良的脑梗死溶栓（mTICI）≥2b率。次要终点包括首过和一线mTICI≥2b率，从动脉切开术到血块接触的次数和mTICI≥2b，90天改良Rankin量表（mRS）≤2。一线和最终mTICI评分由独立的成像核心实验室裁定。安全性事件由独立的临床事件裁决者进行评估。
结果：从2020年7月至2022年6月，在12个中心共招募了108名患者。年龄中位数是67岁,美国国立卫生研究院卒中量表(NIHSS)的中位数为15.5,56.5%的患者接受了静脉溶栓.在程序结束时,97.2%,85.2%,55.6%的患者mTICI≥2b，≥2c,和分别为3。使用SOFIA6F一线抽吸，87.0%,79.6%,52.8%的mTICI≥2b，≥2c,和分别为3。第一次通过后，75.0%,70.4%,50.9%的mTICI≥2b，≥2c,和分别为3。从动脉切开术到凝块接触和成功血运重建的中位时间为12和17分钟，分别。90天,66.7%的患者mRS≤2。
结论：SOFIA6F一线抽吸术安全有效，血运重建率高，手术时间短。
