From the Department of Neurology (M.E.E.), Duke University School of Medicine, Durham, NC.
Duke Clinical Research Institute, Durham, NC (L.L., H.X., A.S.K., A.F.H., E.D.P., Y.X.).
Stroke. 2019 Jun;50(6):1497-1503. doi: 10.1161/STROKEAHA.118.024172. Epub 2019 Apr 30.
Background and Purpose- Acute ischemic stroke patients with history of prior ischemic stroke plus concomitant diabetes mellitus (DM) were excluded from the ECASS III trial (European Cooperative Acute Stroke Study) because of safety concerns. However, there are few data on use of intravenous tissue-type plasminogen activator and symptomatic intracerebral hemorrhage or outcomes in this population. Methods- Using data from the Get With The Guidelines-Stroke Registry between February 2009 and September 2017 (n=1619 hospitals), we examined characteristics and outcomes among patients with acute ischemic stroke treated with tissue-type plasminogen activator within the 3- to 4.5-hour window who had a history of stroke plus diabetes mellitus (HxS+DM) (n=2129) versus those without either history (n=16 690). Results- Compared with patients without either history, those with both prior stroke and DM treated with tissue-type plasminogen activator after an acute ischemic stroke had a higher prevalence of cardiovascular risk factors in addition to history of stroke, DM, and more severe stroke (National Institutes of Health Stroke Scale: median, 8 [interquartile range, 5-15] versus 7 [4-13]). The unadjusted rates of symptomatic intracerebral hemorrhage and in-hospital mortality were 4.3% (HxS+DM) versus 3.8% (without either history; P=0.31) and 6.2% versus 5.5% ( P=0.20), respectively. These differences were not statistically significant after risk adjustment (symptomatic intracerebral hemorrhage: adjusted odds ratio, 0.79 [95% CI, 0.51-1.21]; P=0.28; in-hospital mortality: odds ratio, 0.77 [95% CI, 0.52-1.14]; P=0.19). Unadjusted rate of functional independence (modified Rankin Scale score, 0-2) at discharge was lower in those with HxS+DM (30.9% HxS+DM versus 44.8% without either history; P≤0.0001), and this difference persisted after adjusting for baseline clinical factors (adjusted odds ratio, 0.76 [95% CI, 0.59-0.99]; P=0.04). Conclusions- Among patients with acute ischemic stroke treated with intravenous tissue-type plasminogen activator within the 3- to 4.5-hour window, HxS+DM was not associated with statistically significant increased symptomatic intracerebral hemorrhage or mortality risk.
背景与目的 - 在 ECASS III 试验（欧洲合作急性脑卒中研究）中，由于安全性考虑，将有先前缺血性脑卒中合并同时患有糖尿病（DM）的急性缺血性脑卒中患者排除在外。然而，对于该人群中使用静脉组织型纤溶酶原激活剂和症状性颅内出血或结局的数据较少。方法 - 使用 2009 年 2 月至 2017 年 9 月期间 Get With The Guidelines-Stroke 登记处的数据（n=1619 家医院），我们研究了在 3 至 4.5 小时时间窗内接受组织型纤溶酶原激活剂治疗的急性缺血性脑卒中患者中，有既往脑卒中合并糖尿病病史（HxS+DM）（n=2129）与无该病史（n=16690）患者的特征和结局。结果 - 与无任何病史的患者相比，既往有脑卒中且合并糖尿病病史并在急性缺血性脑卒中后接受组织型纤溶酶原激活剂治疗的患者，除了有脑卒中、DM 病史外，还具有更高的心血管危险因素患病率，且脑卒中更严重（美国国立卫生研究院脑卒中量表评分中位数：8[四分位数范围，5-15] vs 7[4-13]）。未经调整的症状性颅内出血和住院死亡率分别为 4.3%（HxS+DM）和 3.8%（无任何病史；P=0.31）和 6.2%和 5.5%（P=0.20）。在风险调整后，这些差异无统计学意义（症状性颅内出血：调整后比值比，0.79[95%可信区间，0.51-1.21]；P=0.28；住院死亡率：比值比，0.77[95%可信区间，0.52-1.14]；P=0.19）。调整基线临床因素后，HxS+DM 患者出院时的功能独立性（改良 Rankin 量表评分 0-2）较低（30.9% HxS+DM 与无任何病史者的 44.8%；P≤0.0001）。结论 - 在接受 3 至 4.5 小时时间窗内静脉组织型纤溶酶原激活剂治疗的急性缺血性脑卒中患者中，HxS+DM 与症状性颅内出血或死亡率增加无统计学显著相关性。
