Kupelian Varant, Viscidi Emma, Hall Susan, Li Li, Eaton Susan, Dilley Anne, Currier Nicolas, Ferguson Toby, Fanning Laura
Biogen, Cambridge, MA.
Neurol Clin Pract. 2023 Feb;13(1):e200110. doi: 10.1212/CPJ.0000000000200110. Epub 2023 Jan 19.
Reduced mobility in patients with amyotrophic lateral sclerosis (ALS) is hypothesized to increase the risk of venous thromboembolism (VTE). A few small, single-center studies have investigated the risk of VTE in patients with ALS. Given the high morbidity and mortality associated with VTE, further understanding of the risk in patients with ALS may inform clinical care. The objective of this study was to investigate the incidence of VTE in patients with ALS compared with controls without ALS.
Patients were identified from a US health insurance claims database, Optum's deidentified Clinformatics Data Mart Database, between 2004 and 2019. ALS cases were defined as patients aged 18 years or older with (1) 2 or more ALS claims at least 27 days apart including at least 1 claim from a neurologist visit or (2) 1 or more ALS claims and a prescription for riluzole or edaravone. Each ALS case was matched on age and sex to 5 controls without ALS. VTE was defined as at least 1 claim for VTE and at least 1 anticoagulant prescription or VTE-related procedure within 7 days before and 30 days after a VTE claim date. Incidence rates were reported per 1,000 person-years. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using the Cox proportional hazards model.
Among 4,205 ALS cases and 21,025 controls, incident VTE occurred in 132 ALS cases (3.1%) and 244 controls (1.2%). Incidence rates of VTE were 19.9 per 1,000 person-years (95% CI 16.7-23.6) in ALS cases compared with 6.0 per 1,000 person-years (95% CI 5.0-7.1) in controls. ALS cases were about 3 times more likely to develop VTE (HR 3.3, 95% CI 2.6-4.0), with similar results among men and women. The median time to first VTE was 10 months from the initial ALS claim in ALS cases.
Consistent with previous smaller studies, a higher incidence rate of VTE was observed in a large sample of patients with ALS from across the United States, as compared to matched controls. The markedly increased risk underscores the importance of preventive efforts and careful monitoring for VTE in patients with ALS and may have implications for the management of ALS.
据推测，肌萎缩侧索硬化症（ALS）患者活动能力下降会增加静脉血栓栓塞（VTE）风险。少数小型单中心研究对ALS患者的VTE风险进行了调查。鉴于VTE相关的高发病率和高死亡率，进一步了解ALS患者的风险可能会为临床护理提供参考。本研究的目的是调查ALS患者与非ALS对照者相比VTE的发生率。
从美国医疗保险索赔数据库Optum的去识别化临床信息数据集市数据库中识别出2004年至2019年期间的患者。ALS病例定义为年龄在18岁及以上的患者，这些患者满足以下条件之一：（1）间隔至少27天有2次或更多次ALS索赔，其中至少1次来自神经科医生就诊；或（2）有1次或更多次ALS索赔以及利鲁唑或依达拉奉的处方。每个ALS病例按照年龄和性别与5名非ALS对照者进行匹配。VTE定义为在VTE索赔日期前7天和后30天内至少有1次VTE索赔以及至少1次抗凝处方或与VTE相关的程序。发病率按每1000人年报告。使用Cox比例风险模型估计风险比（HRs）和95%置信区间（CIs）。
在4205例ALS病例和21025名对照者中，132例ALS病例（3.1%）和244名对照者（1.2%）发生了VTE事件。ALS病例的VTE发病率为每1000人年19.9例（95%CI 16.7 - 23.6），而对照者为每1000人年6.0例（95%CI 5.0 - 7.1）。ALS病例发生VTE的可能性约为对照者的3倍（HR 3.3，95%CI 2.6 - 4.0），男性和女性的结果相似。ALS病例从首次ALS索赔到首次发生VTE的中位时间为10个月。
与之前规模较小的研究一致，在美国大量ALS患者样本中观察到VTE发病率高于匹配的对照者。显著增加的风险凸显了对ALS患者进行VTE预防措施和密切监测的重要性，并且可能对ALS的管理产生影响。
