Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Stroke Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.
Eur J Neurol. 2024 Dec;31(12):e16502. doi: 10.1111/ene.16502. Epub 2024 Oct 11.
Ambulance trials assessing interventions in suspected stroke patients will recruit patients with currently active symptoms that will resolve into transient ischaemic attack (TIA). The safety and efficacy of glyceryl trinitrate (GTN) in the pre-specified subgroup of patients with TIA in the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial 2 (RIGHT-2) was assessed.
RIGHT-2 was a pre-hospital-initiated multicentre randomized sham-controlled blinded-endpoint trial that randomized patients with presumed ultra-acute stroke within 4 h of symptom onset to transdermal GTN or sham. Final diagnosis was determined by site investigators. The primary outcome was a shift in modified Rankin Scale (mRS) scores at 90 days analysed using ordinal logistic regression reported as adjusted common odds ratio with 95% confidence intervals (CIs). Secondary outcomes included death or dependence (mRS >2).
In all, 109 of 1149 (9.5%) patients had a final diagnosis of TIA (GTN 57, sham 52) with mean age 73 (SD 13) years, 19 (17.4%) had pre-morbid mRS >2, and onset to randomization was 80 min (interquartile range 49, 105). GTN lowered blood pressure by 7.4/5.2 mmHg compared with sham by hospital arrival. At day 90, GTN had no effect on shift in mRS scores (common odds ratio for increased dependence 1.47, 95% CI 0.70-3.11) but was associated with increased death or dependence (mRS >2): GTN 29 (51.8%) versus sham 23 (46.9%), odds ratio 3.86 (95% CI 1.09-13.59).
Pre-hospital ultra-acute transdermal GTN did not improve overall functional outcome in patients with investigator-diagnosed TIA compared with sham treatment.
评估疑似脑卒中患者干预措施的救护车试验将招募目前有症状但会演变为短暂性脑缺血发作（TIA）的患者。在高血压性脑卒中试验 2 期（RIGHT-2）中，对甘油三硝酸酯（GTN）在 TIA 亚组患者中的安全性和有效性进行了预设定组评估。
RIGHT-2 是一项在发病 4 小时内进行的、以预医院启动为特点的、多中心、随机、假对照、盲终点试验，将假定为超急性脑卒中的患者随机分配至经皮 GTN 或假对照治疗。最终诊断由现场研究者确定。主要结局是使用有序逻辑回归分析，以调整后的常见比值比（OR）及其 95%置信区间（CI）报告的 90 天改良 Rankin 量表（mRS）评分变化，该分析为意向性治疗分析。次要结局包括死亡或依赖（mRS >2）。
在总共 1149 例患者中，109 例（9.5%）患者的最终诊断为 TIA（GTN 57 例，假对照 52 例），平均年龄 73（13）岁，19 例（17.4%）有预先存在的 mRS >2，发病至随机分组时间为 80 分钟（四分位间距 49，105）。与假对照相比，GTN 可使血压在入院时降低 7.4/5.2mmHg。在第 90 天，GTN 对 mRS 评分的变化没有影响（增加依赖的常见 OR 为 1.47，95%CI 0.70-3.11），但与增加的死亡或依赖（mRS >2）相关：GTN 29 例（51.8%）与假对照 23 例（46.9%），OR 为 3.86（95%CI 1.09-13.59）。
与假对照治疗相比，院前超急性经皮 GTN 并不能改善经研究者诊断为 TIA 的患者的整体功能结局。
