超急性疑似卒中患者的院前经皮硝酸甘油治疗（RIGHT-2）：一项基于救护车的随机、假对照、盲法、III期优效性试验中第365天的疗效观察
Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): effects on outcomes at day 365 in a randomised, sham-controlled, blinded, phase III, superiority ambulance-based trial.
作者信息
Woodhouse Lisa J, Appleton Jason P, Ankolekar Sandeep, England Timothy J, Mair Grant, Muir Keith, Price Christopher I, Pocock Stuart, Randall Marc, Robinson Thompson G, Roffe Christine, Sandset Else C, Saver Jeffrey L, Siriwardena Aloysius Niroshan, Sprigg Nikola, Wardlaw Joanna M, Bath Philip M
机构信息
Stroke Trials Unit, Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.
Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK.
出版信息
BMJ Neurol Open. 2023 Jun 27;5(1):e000424. doi: 10.1136/bmjno-2023-000424. eCollection 2023.
BACKGROUND
The Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial-2 (RIGHT-2) reported no overall treatment difference between glyceryl trinitrate (GTN) and sham at day 90. Here we assess participants' outcomes 1 year after randomisation.
METHODS
RIGHT-2 was an ambulance-based prospective randomised controlled trial where patients with presumed stroke and systolic blood pressure (BP) of >120 mm Hg received either GTN (5 mg/day) or sham patch. Centralised blinded telephone follow-up was performed at days 90 (primary endpoint) and 365 (secondary endpoint). The lead outcome was dependency assessed with the modified Rankin Scale (mRS).
RESULTS
1149 patients were recruited to RIGHT-2 between October 2015 and May 2018, and 1097 (95.5%) had outcome data recorded at day 365. At baseline, the patients were; female (48%), had a mean age of 73 (15) years, BP of 162 (25)/92 (18) mm Hg, onset to randomisation of 70 (45-115) min, diagnosis of ischaemic stroke (52%), intracerebral haemorrhage (ICH) (13%), transient ischaemic attack (TIA) (9%) and mimics (26%). There was no effect of GTN on mRS score at day 365 in participants with confirmed stroke/TIA (adjusted common odds ratio (acOR) 1.10, 95% CI 0.86 to 1.42) or in all patients. In patients randomised to GTN, mRS at day 365 tended to be worse in those with ICH (acOR 1.65, 95% CI 0.84 to 3.25) and better in those with a mimic diagnosis (acOR 0.53, 95% CI 0.33 to 0.84).
CONCLUSION
At 1 year post randomisation, dependency did not differ between GTN and sham treatment in either the target population or overall. In prespecified subgroup analyses, GTN was associated with reduced dependency in participants with a final diagnosis of mimic and a non-significant worse outcome in participants with ICH.
TRIAL REGISTRATION NUMBER
ISRCTN26986053.
背景
硝酸甘油在高血压性卒中试验-2（RIGHT-2）中报告称，在第90天时硝酸甘油（GTN）与安慰剂之间无总体治疗差异。在此，我们评估随机分组1年后参与者的结局。
方法
RIGHT-2是一项基于救护车的前瞻性随机对照试验，疑似卒中且收缩压（BP）>120 mmHg的患者接受GTN（5 mg/天）或安慰剂贴片治疗。在第90天（主要终点）和第365天（次要终点）进行集中盲态电话随访。主要结局是用改良Rankin量表（mRS）评估的依赖性。
结果
2015年10月至2018年5月期间共有1149例患者纳入RIGHT-2研究，1097例（95.5%）在第365天有结局数据记录。基线时，患者为女性（48%），平均年龄73（15）岁，血压为162（25）/92（18）mmHg，随机分组时发病至随机分组时间为70（45 - 115）分钟，诊断为缺血性卒中（52%）、脑出血（ICH）（13%）、短暂性脑缺血发作（TIA）（9%）和疑似卒中（26%）。在确诊的卒中/TIA患者或所有患者中，GTN在第365天时对mRS评分无影响。在随机接受GTN治疗的患者中，第365天时ICH患者的mRS评分往往更差（校正共同比值比（acOR）1.65，95%CI 0.84至3.25），疑似卒中诊断患者的mRS评分更好（acOR 0.53，95%CI 0.33至0.84）。
结论
随机分组1年后，在目标人群或总体中，GTN与安慰剂治疗之间的依赖性无差异。在预先设定的亚组分析中，GTN与最终诊断为疑似卒中的参与者依赖性降低相关，与ICH参与者结局稍差但无统计学意义相关。
试验注册号
ISRCTN26986053。
Zotero 插件