Purpose

Intravenous Thrombolysis (IV rt-PA) is administered in <10% of ischemic stroke patients. In rare cases, patients or caregivers refuse IV rt-PA treatment even when recommended by stroke practitioners. We sought to assess the characteristics and outcomes of patients who refuse IV rt-PA for acute ischemic stroke, and to compare outcomes between those who were treated with IV rt-PA and those who refused.

Methods

We examined data from the prospectively collected, IRB approved UC San Diego Stroke Registry who presented as a “stroke code” from July 2004 to July 2019 at two academic facilities and five community hospitals. Patients were included if they presented within 4.5 hours of symptom onset or last seen normal, had a “stroke code” alert activated, and were either treated with IV rt-PA or the reason for exclusion was patient/family refusal. Patients were considered “refusers” if IV rt-PA was recommended by the provider during the stroke code and the patient and/or legally authorized representative declined treatment. Baseline demographics, baseline National Institutes of Health Stroke Scale (NIHSS), treatment times and 90-day Modified Rankin Scale (mRS) were collected. Patients who refused IV rt-PA were compared to those that were treated with IV rt-PA. Data was examined for frequencies and distribution. Chi squared was used to evaluate nominal variables. Continuous variables were assessed by Pearson correlation and t test. Kruskal-Wallis or ANOVA were used to evaluate group differences.

Results

A total of 1056 patients were included in the analysis. Forty-seven patients (4.5%) refused IV rt-PA. There were no significant socio-demographic differences between patients who were treated with IV rt-PA and those who refused. Compared to patients who were treated with IV rt-PA, patients who refused IV rt-PA had a significantly lower baseline NIHSS (4 vs 9, p < 0.0001) and higher baseline mRS (IQR 0-1.0 vs 0-2.8, p < 0.001). The time from arrival to treatment decision was significantly longer in patients who refused IV rt-PA (group mean 57.9 min vs 48.8 min, p = 0.03). Data for 90-day outcome was available for 556 (55.1%) patients treated with IV rt-PA and 20 (42.5%) patients who refused IV rt-PA. There was no difference in 90-day mRS between groups (p = 0.68).

Conclusions

There is a low rate of IV rt-PA refusal in our registry population which is similar to what previous studies have shown. We found that patients who refuse IV rt-PA have significantly milder deficits and significantly worse pre-morbid disability. We speculate that the longer “arrival to decision” time in the refuse IV rt-PA group is due to longer informed consent discussions. This analysis furthers the body of literature regarding rt-PA refusals.

中文翻译：

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拒绝静脉溶栓治疗急性缺血性中风的患者的特征和结果-圣地亚哥体验

目的

在缺血性中风患者中，<10％进行静脉溶栓（IV rt-PA）。在极少数情况下，即使中风从业者推荐，患者或护理人员也拒绝接受IV rt-PA治疗。我们试图评估拒绝接受静脉rt-PA治疗的急性缺血性卒中患者的特征和结局，并比较接受静脉rt-PA治疗的患者和拒绝接受rt-PA的患者的结果。

方法

我们检查了来自IRB批准的前瞻性收集数据，该数据由2004年7月至2019年7月在两家学术机构和五家社区医院以“中风代码”的形式提交给UC San Diego中风注册中心。如果患者在症状发作的4.5小时内出现或最后一次见正常，就被包括在内，并且接受了“卒中代码”警报，并且接受了静脉rt-PA治疗或排除的原因是患者/家属拒绝。如果提供者在卒中代码期间推荐IV rt-PA，并且患者和/或合法授权的代表拒绝治疗，则将患者视为“拒绝接受者”。收集基线人口统计数据，基线美国国立卫生研究院卒中量表（NIHSS），治疗时间和90天改良Rankin量表（mRS）。将拒绝接受静脉rt-PA的患者与接受静脉rt-PA治疗的患者进行比较。检查数据的频率和分布。卡方被用来评估名义变量。连续变量通过Pearson相关和t检验进行评估。使用Kruskal-Wallis或ANOVA评估组差异。

结果

分析中总共包括1056名患者。47名患者（4.5％）拒绝静脉rt-PA。IV rt-PA治疗的患者和拒绝治疗的患者在社会人口统计学上无显着差异。与接受IV rt-PA治疗的患者相比，拒绝接受IV rt-PA的患者的基线NIHSS明显较低（4 vs 9，p <0.0001），基线mRS较高（IQR 0-1.0 vs 0-2.8，p < 0.001）。拒绝接受IV rt-PA的患者从到达到决定治疗的时间明显更长（组平均57.9分钟对48.8分钟，p = 0.03）。有556名（55.1％）接受静脉rt-PA治疗的患者和20名（42.5％）拒绝接受静脉rt-PA的患者有90天结果的数据。两组之间的90天mRS没有差异（p = 0.68）。

结论

在我们的登记人群中，IV rt-PA拒绝的比率很低，这与以前的研究相似。我们发现拒绝IV rt-PA的患者的赤字明显较轻，病前残疾严重恶化。我们推测，拒绝IV rt-PA组中的“到达决策”时间更长是由于进行了更长时间的知情同意讨论。这种分析进一步促进了有关rt-PA拒绝的文献。