Objective

We examined the impact of expansion of the time window (from 3 to 4.5 hours) in the labeled indication for recombinant tissue-plasminogen activator (rt-PA) in August 2012 on the use of rt-PA for patients with acute ischemic stroke (AIS) and the outcomes of patients treated with rt-PA.

Materials and Methods

Using a Japanese nationwide inpatient claims database, we identified patients with AIS who admitted to hospitals that consecutively participated in the database from 2010 to 2014. We defined the pre-expansion period as before August 2012 and the post-expansion period as after August 2012. We conducted an interrupted time-series analysis using patient-level data to examine the association between the expansion and use of rt-PA. We also assessed the association of the expansion with outcomes in patients treated with rt-PA.

Results

Among 257,778 patients with AIS, 4.5% patients (5,796/129,326) were treated with rt-PA in the pre-expansion period and 5.8% patients (7,483/128,452) were treated with rt-PA in the post-expansion period. The expansion was associated with greater use of rt-PA (adjusted odds ratio [aOR], 1.35; 95% confidence interval [CI], 1.24–1.48). Among patients treated with rt-PA, the expansion was associated with functional independence (modified Rankin scale of ≤2) at discharge (aOR, 1.26; 95% CI, 1.03–1.54), but not with in-hospital mortality (aOR, 0.92; 95% CI, 0.68–1.24).

Conclusions

This study showed that expansion of the time window for rt-PA was associated with increased use of rt-PA in patients with AIS, while the functional outcome at discharge was improved after the expansion in patients treated with rt-PA.

中文翻译：

---

在日本中风后3至4.5小时将重组组织纤溶酶原激活剂的适应症扩大

目的

我们研究了2012年8月重组组织型纤溶酶原激活剂（rt-PA）标记适应症中时间窗的扩展（从3到4.5小时）对急性缺血性中风（AIS）患者使用rt-PA的影响）以及接受rt-PA治疗的患者的结局。

材料和方法

使用日本全国住院患者索赔数据库，我们确定了2010年至2014年连续进入该数据库的医院收治的AIS患者。我们将扩展前的时期定义为2012年8月之前，将扩展后的时期定义为2012年8月之后。我们使用患者水平的数据进行了中断的时间序列分析，以检查rt-PA的扩展与使用之间的关联。我们还评估了接受rt-PA治疗的患者的扩张与预后的关系。

结果

在257,778名AIS患者中，有4.5％（5,796 / 129,326）的患者在扩张前接受了rt-PA治疗，有5.8％（7,483 / 128,452）的患者在扩张后接受了rt-PA治疗。扩大与rt-PA的更多使用有关（调整后的优势比[aOR]为1.35； 95％的置信区间[CI]为1.24-1.48）。在接受rt-PA治疗的患者中，扩张与出院时的功能独立性（改良的兰金评分≤2）相关（aOR为1.26； 95％CI为1.03-1.54），而与院内死亡率无关（aOR为0.92） ； 95％CI，0.68–1.24）。

结论

这项研究表明，rt-PA时间窗的扩大与AIS患者使用rt-PA的使用增加有关，而rt-PA治疗的患者扩大后出院时的功能结局得到改善。