Stroke, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK.
Stroke Vasc Neurol. 2024 Feb 27;9(1):38-49. doi: 10.1136/svn-2022-001634.
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).
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.
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.
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.
在疑似中风患者住院前使用经皮甘油三硝酸酯（GTN，一种硝基血管扩张剂）对临床结局的影响尚不清楚。在这里，我们评估了 GTN 在 Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2（RIGHT-2）中缺血性中风患者预设亚组中的安全性和疗效。
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 天改良 Rankin 量表（mRS）评分的变化。次要结局包括死亡；包含巴氏指数、欧洲五维健康量表、mRS、电话访谈认知状态改良和 Zung 抑郁量表的全球分析（Wei-Lachin 检验）；以及神经影像学确定的“大脑脆弱”标志物。数据以 n（%）、均值（SD）、中位数 [IQR]、调整后的常见比值比（acOR）、均值差或 Mann-Whitney 差（MWD）表示，95%CI。
1149 例患者中 597 例（52%）最终诊断为缺血性中风；年龄 75（12）岁，发病前 mRS>2 107 例（18%），格拉斯哥昏迷量表 14 分（2 分），发病至随机分组时间 67 [45, 108] 分钟。神经影像学“大脑脆弱”很常见：中位数评分为 2 [2, 3]（范围 0-3）。第 90 天，GTN 对主要结局无影响（残疾加重的 acOR 为 1.15，95%CI 为 0.85 至 1.54），死亡率或全球分析（MWD 0.00，95%CI -0.10 至 0.09）。亚组分析提示 GTN 与症状发作后 1 小时内随机分组的患者以及中风更严重的患者的死亡率和依赖性增加存在非显著交互作用。
在患有缺血性中风的患者中，与以往住院试验相比，在救护车中超急性给予经皮 GTN 并未改善更具临床和放射学脆弱性的人群的临床结局。
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