Swedish Medical Center, Englewood, Colorado, USA.
J Neurointerv Surg. 2013 May;5 Suppl 1:i74-6. doi: 10.1136/neurintsurg-2012-010585. Epub 2013 Jan 7.
Revascularization of acute ischemic stroke from a large vessel occlusion continues to be a challenge with current thrombectomy devices. The purpose of the SPEED study was to report the safety and effectiveness of the Penumbra 054 Reperfusion Catheter System in revascularizing large vessel occlusions.
In this retrospective multicenter study, data were collected from patients with angiographic evidence of large vessel occlusion treated with the Penumbra 054 device as the intended primary therapy. Clinical outcome data were collected with 90-day follow-up and the results were compared with those from the Penumbra Pivotal trial.
Eighty-seven target vessels in 86 consecutive patients treated with the Penumbra 054 device were included. The Thrombolysis In Myocardial Infarction (TIMI) 2 or 3 revascularization rate was 91% compared with a reported 82% in the Penumbra Pivotal trial. This was accomplished in a median time of 20 min compared with 45 min in the Penumbra Pivotal trial (p<0.0001). Eighteen (21%) patients experienced an intracranial hemorrhage of which 12 (14%) were symptomatic. Good neurologic outcome (modified Rankin scores ≤ 2) at 90-day follow-up was achieved in 34.9% of patients compared with 25% reported in the Penumbra Pivotal trial. All-cause mortality was 25.6%.
These results suggest that the Penumbra 054 is a fast, safe and effective revascularization tool for patients experiencing ischemic stroke secondary to large vessel occlusive disease. Improvements in speed and effectiveness of revascularization probably contributed to improved outcomes.
目前使用取栓装置对大血管闭塞引起的急性缺血性脑卒中进行再通仍然具有挑战性。SPEED 研究的目的是报告 Penumbra 054 再灌注导管系统在再通大血管闭塞中的安全性和有效性。
在这项回顾性多中心研究中，从接受 Penumbra 054 装置治疗的有大血管闭塞血管造影证据的患者中收集数据，该装置被用作主要的初始治疗。在 90 天的随访中收集临床结果数据，并将结果与 Penumbra 关键性试验进行比较。
共纳入 86 例连续患者的 87 个靶血管接受了 Penumbra 054 装置治疗。与 Penumbra 关键性试验报告的 82%相比，血管再通率为 91%，达到了血栓溶栓（TIMI）2 或 3 级。这是在中位数 20 分钟内完成的，而在 Penumbra 关键性试验中则需要 45 分钟（p<0.0001）。18 例（21%）患者发生颅内出血，其中 12 例（14%）为症状性颅内出血。90 天随访时获得良好神经功能结局（改良 Rankin 评分≤2）的患者比例为 34.9%，而 Penumbra 关键性试验报告的比例为 25%。全因死亡率为 25.6%。
这些结果表明，Penumbra 054 是一种快速、安全、有效的再通工具，可用于治疗由大血管闭塞性疾病引起的缺血性脑卒中。再通速度和效果的提高可能有助于改善结局。
