Department of Neurology and Psychiatry, La Sapienza University of Rome, Italy.
Neurology. 2012 Mar 20;78(12):880-7. doi: 10.1212/WNL.0b013e31824d966b. Epub 2012 Mar 7.
To assess safety and efficacy of thrombolysis in 18- to 50-year-old patients compared to those aged 51 to 80 years recorded in the Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register (SITS-ISTR).
A total of 27,671 patients aged 18-80 years treated with IV alteplase within 4.5 hours of symptom onset were enrolled in SITS-ISTR between 2002 and 2010. Main outcome measures were symptomatic intracerebral hemorrhage (SICH; deterioration of ≥4 points on the NIH Stroke Scale [NIHSS] within 24 hours and type 2 parenchymal hematoma), mortality, and functional independence (modified Rankin Scale [mRS] 0-2) at 3 months.
In the 3,246 (11.7%) patients aged 18-50, SICH occurred in 0.6% vs 1.9% in those aged 51-80 (adjusted odds ratio [aOR] 0.53; 95% confidence interval [CI] 0.31-0.90, p = 0.02). Three-month mortality was 4.9% and 14.4%, respectively (aOR 0.49; 95% CI 0.40-0.60, p < 0.001) and functional independence was 72.1% vs 54.5%, respectively (aOR 1.61; 95% CI 1.43-1.80, p < 0.0001). In multivariable analysis in young patients, baseline systolic blood pressure (SBP) was the only independent factor associated with SICH (p = 0.04). Baseline NIHSS, baseline glucose, and signs of infarction in baseline imaging scan were associated with higher mortality and poorer functional outcome. Male gender, mRS before stroke, and atrial fibrillation (AF) were associated with higher mortality, and age, SBP, and previous stroke were associated with mRS.
Treatment with IV alteplase is safe in young ischemic stroke patients and they benefit more compared to older patients. We found several factors associated with SICH, mortality, and functional outcome. These can be used to help in the selection of young ischemic stroke patients for thrombolysis.
This study provides Class III evidence that younger patients (18-50 years) with ischemic stroke symptoms treated with IV alteplase have lower morbidity and mortality compared to older patients (51-80 years).
评估在年龄为 18 至 50 岁的患者中与年龄为 51 至 80 岁的患者相比，溶栓治疗的安全性和疗效，这些数据记录于安全实施溶栓治疗缺血性卒中-国际卒中溶栓登记研究（Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register，SITS-ISTR）中。
2002 年至 2010 年间，共有 27671 例年龄在 18 至 80 岁之间、症状发作后 4.5 小时内接受 IV 阿替普酶治疗的患者纳入 SITS-ISTR。主要结局指标为症状性颅内出血（symptomatic intracerebral hemorrhage，SICH；24 小时内 NIHSS 恶化≥4 分和 2 型实质血肿）、死亡率和 3 个月时的功能独立性（改良 Rankin 量表[modified Rankin Scale，mRS]0-2）。
在 3246 例（11.7%）年龄在 18-50 岁的患者中，SICH 发生率为 0.6%，而年龄在 51-80 岁的患者为 1.9%（调整后的优势比[aOR]0.53；95%置信区间[CI]0.31-0.90，p=0.02）。3 个月死亡率分别为 4.9%和 14.4%（aOR0.49；95%CI0.40-0.60，p<0.001），功能独立性分别为 72.1%和 54.5%（aOR1.61；95%CI1.43-1.80，p<0.0001）。在年轻患者的多变量分析中，基线收缩压（systolic blood pressure，SBP）是唯一与 SICH 相关的独立因素（p=0.04）。基线 NIHSS、基线血糖和基线影像学扫描中的梗死迹象与更高的死亡率和更差的功能结局相关。男性、卒中前 mRS 和心房颤动（atrial fibrillation，AF）与更高的死亡率相关，年龄、SBP 和既往卒中与 mRS 相关。
在年轻的缺血性脑卒中患者中，IV 阿替普酶治疗是安全的，与年龄较大的患者相比，他们的获益更多。我们发现了一些与 SICH、死亡率和功能结局相关的因素。这些因素可用于帮助选择年轻的缺血性脑卒中患者进行溶栓治疗。
本研究提供了 III 级证据，表明接受 IV 阿替普酶治疗的年轻（18-50 岁）缺血性脑卒中患者的发病率和死亡率低于年龄较大的患者（51-80 岁）。
