Background The effect of transdermal glyceryl trinitrate (GTN, a nitrovasodilator) on clinical outcome when administered before hospital admission in suspected stroke patients is unclear. Here, we assess the safety and efficacy of GTN in the prespecified subgroup of patients who had an ischaemic stroke within the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2). Methods RIGHT-2 was an ambulance-based multicentre sham-controlled blinded-endpoint study with patients randomised within 4 hours of onset. The primary outcome was a shift in scores on the modified Rankin scale (mRS) at day 90. Secondary outcomes included death; a global analysis (Wei-Lachin test) containing Barthel Index, EuroQol-5D, mRS, telephone interview for cognitive status-modified and Zung depression scale; and neuroimaging-determined ‘brain frailty’ markers. Data were reported as n (%), mean (SD), median [IQR], adjusted common OR (acOR), mean difference or Mann-Whitney difference (MWD) with 95% CI. Results 597 of 1149 (52%) patients had a final diagnosis of ischaemic stroke; age 75 (12) years, premorbid mRS>2 107 (18%), Glasgow Coma Scale 14 (2) and time from onset to randomisation 67 \[45, 108] min. Neuroimaging ‘brain frailty’ was common: median score 2 [2, 3\] (range 0–3). At day 90, GTN did not influence the primary outcome (acOR for increased disability 1.15, 95% CI 0.85 to 1.54), death or global analysis (MWD 0.00, 95% CI −0.10 to 0.09). In subgroup analyses, there were non-significant interactions suggesting GTN may be associated with more death and dependency in participants randomised within 1 hour of symptom onset and in those with more severe stroke. Conclusions In patients who had an ischaemic stroke, ultra-acute administration of transdermal GTN in the ambulance did not improve clinical outcomes in a population with more clinical and radiological frailty than seen in previous in-hospital trials. Data are available on reasonable request. Data are available on reasonable request to the corresponding author.

中文翻译：

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院前透皮三硝酸甘油治疗超急性缺血性中风：来自 RIGHT-2 随机假手术对照救护车试验的数据

背景 对于疑似中风患者入院前使用经皮三硝酸甘油酯（GTN，一种硝基血管扩张剂）对临床结果的影响尚不清楚。在此，我们在高血压脑卒中试验 2 (RIGHT-2) 中三硝酸甘油快速干预试验中评估了 GTN 在预先指定的缺血性脑卒中患者亚组中的安全性和有效性。方法 RIGHT-2 是一项基于救护车的多中心假对照盲终点研究，患者在发病后 4 小时内随机分组。主要结局是第 90 天时改良 Rankin 量表 (mRS) 评分的变化。次要结局包括死亡；全局分析（Wei-Lachin 测试），包含 Barthel 指数、EuroQol-5D、mRS、认知状态修正电话访谈和 Zung 抑郁量表；以及神经影像学确定的“大脑脆弱”标记。数据报告为 n (%)、平均值 (SD)、中位数 [IQR]、调整共同 OR (acOR)、平均差或 Mann-Whitney 差 (MWD)（95% CI）。结果 1149 名患者中有 597 名 (52%) 最终诊断为缺血性中风；年龄 75 (12) 岁，病前 mRS>2 107 (18%)，格拉斯哥昏迷量表 14 (2)，从发病到随机化的时间 67 \[45, 108] 分钟。神经影像学“大脑衰弱”很常见：中位得分 2 [2, 3\]（范围 0–3）。第90天时，GTN不影响主要结局（残疾增加的acOR 1.15，95% CI 0.85至1.54）、死亡或总体分析（MWD 0.00，95% CI -0.10至0.09）。在亚组分析中，不显着的相互作用表明 GTN 可能与症状出现 1 小时内随机分组的参与者以及患有更严重中风的参与者更多的死亡和依赖性有关。结论 在患有缺血性中风的患者中，在救护车上超急性施用经皮 GTN 并不能改善临床和放射学虚弱人群的临床结果，这一点比之前的院内试验中所见。可根据合理要求提供数据。数据可根据相应作者的合理要求提供。