Minhas Jatinder S, Wang Xia, Arima Hisatomi, Bath Philip M, Billot Laurent, Broderick Joseph P, Donnan Geoffrey A, Kim Jong S, Lavados Pablo M, Lee Tsong-Hai, Martins Sheila Cristina Ouriques, Olavarría Verónica V, Pandian Jeyaraj D, Pontes-Neto Octávio Marques, Ricci Stefano, Sato Shoichiro, Sharma Vijay K, Thang Nguyen H, Wang Ji-Guang, Woodward Mark, Chalmers John, Anderson Craig S, Robinson Thompson G
Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.
The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Cerebrovasc Dis. 2018;45(5-6):213-220. doi: 10.1159/000488911. Epub 2018 Apr 27.
Debate exists as to whether statin pretreatment confers an increased risk of 90-day mortality and symptomatic intracranial haemorrhage (sICH) in acute ischaemic stroke (AIS) patients treated with intravenous thrombolysis. We assessed the effects of undifferentiated lipid-lowering pretreatment on outcomes and interaction with low-dose versus standard-dose alteplase in a post hoc subgroup -analysis of the Enhanced Control of Hypertension and Thrombolysis Stroke Study.
In all, 3,284 thrombolysis-eligible AIS patients (mean age 66.6 years; 38% women), with information on lipid-lowering pretreatment, were randomly assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) intravenous alteplase within 4.5 h of symptom onset. Of the total number of patients, 615 (19%) received statin or other lipid-lowering pretreatment. The primary clinical outcome was combined endpoint of death or disability (modified Rankin Scale scores 2-6) at 90 days.
Compared with patients with no lipid-lowering pretreatment, those with lipid-lowering pretreatment were significantly older, more likely to be non-Asian and more likely to have a medical history including vascular co-morbidity. After propensity analysis assessment and adjustment for important baseline variables at the time of randomisation, as well as imbalances in management during the first 7 days of hospital admission, there were no significant differences in mortality (OR 0.85; 95% CI 0.58-1.25, p = 0.42), or in overall -90-day death and disability (OR 0.85, 95% CI 0.67-1.09, p = 0.19), despite a significant decrease in sICH among those with -lipid-lowering pretreatment according to the European Co-operative Acute Stroke Study 2 definition (OR 0.49, 95% CI 0.28-0.83, p = 0.009). No differences in key efficacy or safety outcomes were seen in patients with and without lipid-lowering pretreatment between low- and standard-dose alteplase arms.
Lipid-lowering pretreatment is not associated with adverse outcome in AIS patients treated with intravenous alteplase, whether assessed by 90-day death and disability or death alone.
对于接受静脉溶栓治疗的急性缺血性卒中（AIS）患者，他汀类药物预处理是否会增加90天死亡率和症状性颅内出血（sICH）的风险存在争议。在高血压强化控制与溶栓卒中研究的事后亚组分析中，我们评估了未区分的降脂预处理对结局的影响以及与低剂量和标准剂量阿替普酶的相互作用。
共有3284例符合溶栓条件的AIS患者（平均年龄66.6岁；38%为女性），有降脂预处理信息，在症状发作后4.5小时内被随机分配接受低剂量（0.6mg/kg）或标准剂量（0.9mg/kg）静脉阿替普酶治疗。在患者总数中，615例（19%）接受了他汀类药物或其他降脂预处理。主要临床结局是90天时死亡或残疾的复合终点（改良Rankin量表评分2 - 6分）。
与未进行降脂预处理的患者相比，进行降脂预处理的患者年龄显著更大，更可能是非亚洲人，更可能有包括血管合并症在内的病史。在进行倾向分析评估并对随机分组时的重要基线变量以及入院后前7天管理中的不平衡进行调整后，死亡率（OR 0.85；95%CI 0.58 - 1.25，p = 0.42）或90天总体死亡和残疾率（OR 0.85，95%CI 0.67 - 1.09，p = 0.19）没有显著差异，尽管根据欧洲急性卒中协作研究2定义，进行降脂预处理的患者中sICH显著减少（OR 0.49，95%CI 0.28 - 0.83，p = 0.009）。在低剂量和标准剂量阿替普酶组中，有和没有降脂预处理的患者在关键疗效或安全性结局方面没有差异。
对于接受静脉阿替普酶治疗的AIS患者，无论通过90天死亡和残疾还是仅通过死亡来评估，降脂预处理均与不良结局无关。
