Stroke Program, University of Alberta, Canada.
Stroke. 2011 Jun;42(6):1680-90. doi: 10.1161/STROKEAHA.110.609933. Epub 2011 May 12.
Fewer than 5% of patients with acute ischemic stroke are currently treated, and there is need for additional treatment options. A novel catheter treatment (NeuroFlo) that increases cerebral blood flow was tested to 14 hours.
The Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management. The primary safety end point was the incidence of serious adverse events through 90 days. The primary efficacy end point on a modified intent-to-treat population was a global disability end point at 90 days. Secondary end points included mortality, intracranial hemorrhage, modified Rankin scale score outcome of 0 to 2, and modified Rankin scale shift analysis.
Between October 2005 and January 2010, 515 patients were enrolled at 68 centers in 9 countries. The primary efficacy end point did not reach statistical significance (OR, 1.17; CI, 0.81-1.67; P=0.407). The primary safety end point did not show a difference in serious adverse events (P=0.923). Ninety-day mortality was 11.3% (26/230) in treatment and 16.3% (42/257) in control (P=0.087). Post hoc analyses showed that patients presenting within 5 hours (OR, 3.33; CI, 1.31-8.48), with NIHSS score 8 to 14 (OR, 1.80; CI, 0.99-3.30), or older than age 70 years (OR, 2.02; CI, 1.02-4.03) had better modified Rankin scale score outcomes of 0 to 2; additionally, there were fewer stroke-related deaths in treatment compared to control groups (7.4% = 17/230; 14.4% = 37/257).
The trial met its primary safety end point but not its primary efficacy end point. Signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation.
URL: http://clinicaltrials.gov. Unique identifier: NCT00119717.
目前仅有不到 5%的急性缺血性脑卒中患者接受治疗，因此需要更多的治疗选择。本研究旨在测试一种可增加脑血流的新型导管治疗（NeuroFlo），该治疗可延长至 14 小时。
NeuroFlo 在急性缺血性脑卒中中的安全性和有效性研究是一项随机试验，旨在评估 NeuroFlo 治疗在改善神经功能预后方面与标准药物治疗相比的安全性和有效性。主要安全性终点是 90 天内严重不良事件的发生率。主要疗效终点是改良意向治疗人群中 90 天的总体残疾终点。次要终点包括死亡率、颅内出血、改良 Rankin 量表评分 0-2 分、改良 Rankin 量表移位分析。
2005 年 10 月至 2010 年 1 月，在 9 个国家的 68 个中心共招募了 515 例患者。主要疗效终点未达到统计学意义（比值比，1.17；95%置信区间，0.81-1.67；P=0.407）。主要安全性终点未显示严重不良事件差异（P=0.923）。治疗组 90 天死亡率为 11.3%（26/230），对照组为 16.3%（42/257）（P=0.087）。事后分析显示，发病 5 小时内（比值比，3.33；95%置信区间，1.31-8.48）、NIHSS 评分 8-14 分（比值比，1.80；95%置信区间，0.99-3.30）或年龄大于 70 岁（比值比，2.02；95%置信区间，1.02-4.03）的患者改良 Rankin 量表评分 0-2 分的比例更好；此外，治疗组卒中相关性死亡率低于对照组（7.4%=26/351；14.4%=42/294）。
该试验达到了主要安全性终点，但未达到主要疗效终点。所有原因死亡率、发病早、年龄大于 70 岁或中度脑卒中患者均显示出治疗效果的信号，但这些信号需要进一步证实。
