Behrouz Réza, Masjuán-Vallejo Jaime, Vera Rocío, Willey Joshua Z, Zedet Mickael, Moulin Solène, Cordonnier Charlotte, Klijn Catharina J M, Kanselaar Karin, Dirks Maaike, Silver Brian, Khan Muhib, Azarpazhooh Mahmoud R, Godoy Daniel A, Roffe Christine, Paley Lizz, Bray Benjamin D, Smith Craig J, Di Napoli Mario
Department of Neurology, School of Medicine, University of Texas Health Science Center, San Antonio, Texas.
Department of Neurology, Ramón y Cajal University Hospital, Universidad de Alcala, Madrid, Spain.
J Stroke Cerebrovasc Dis. 2018 Jan;27(1):246-256. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.031. Epub 2017 Sep 19.
Nonagenarians are under-represented in thrombolytic trials for acute ischemic stroke (AIS). The effectiveness of intravenous thrombolytics in nonagenarians in terms of safety and outcome is not well established.
We used a multinational registry to identify patients aged 90 years or older with good baseline functional status who presented with AIS. Differences in outcomes-disability level at 90 days, frequency of symptomatic intracerebral hemorrhage (sICH), and mortality-between patients who did and did not receive thrombolytics were assessed using multivariable logistic regression, adjusted for prespecified prognostic factors. Coarsened exact matching (CEM) was utilized before evaluating outcome by balancing both groups in the sensitivity analysis.
We identified 227 previously independent nonagenarians with AIS; 122 received intravenous thrombolytics and 105 did not. In the unmatched cohort, ordinal analysis showed a significant treatment effect (adjusted common odds ratio [OR]: .61, 95% confidence interval [CI]: .39-.96). There was an absolute difference of 8.1% in the rate of excellent outcome in favor of thrombolysis (17.4% versus 9.3%; adjusted ratio: .30, 95% CI: .12-.77). Rates of sICH and in-hospital mortality were not different. Similarly, in the matched cohort, CEM analysis showed a shift in the primary outcome distribution in favor of thrombolysis (adjusted common OR: .45, 95% CI: .26-.76).
Nonagenarians treated with thrombolytics showed lower stroke-related disability at 90 days than those not treated, without significant difference in sICH and in-hospital mortality rates. These observations cannot exclude a residual confounding effect, but provide evidence that thrombolytics should not be withheld from nonagenarians because of age alone.
在急性缺血性卒中(AIS)溶栓试验中,九旬老人的代表性不足。静脉溶栓对九旬老人在安全性和预后方面的有效性尚未明确。
我们使用一个跨国登记系统来识别90岁及以上、基线功能状态良好且患有AIS的患者。使用多变量逻辑回归评估接受和未接受溶栓治疗的患者在结局方面的差异——90天时的残疾水平、症状性脑出血(sICH)的发生率和死亡率,并对预先指定的预后因素进行调整。在敏感性分析中,通过平衡两组来评估结局之前,采用了粗化精确匹配(CEM)。
我们识别出227例先前独立的患有AIS的九旬老人;122例接受了静脉溶栓治疗,105例未接受。在未匹配的队列中,序贯分析显示出显著的治疗效果(调整后的共同优势比[OR]:0.61,95%置信区间[CI]:0.39 - 0.96)。溶栓组的良好结局率绝对差异为8.1%(17.4%对9.3%;调整后的比值:0.30,95% CI:0.12 - 0.77)。sICH发生率和住院死亡率无差异。同样,在匹配的队列中,CEM分析显示主要结局分布向有利于溶栓治疗的方向转变(调整后的共同OR:0.45,95% CI:0.26 - 0.76)。
接受溶栓治疗的九旬老人在90天时与未接受治疗的相比,卒中相关残疾程度更低,sICH发生率和住院死亡率无显著差异。这些观察结果不能排除残留的混杂效应,但提供了证据表明不应仅因年龄而不给九旬老人使用溶栓药物。