From the Departments of Clinical Neurosciences and Diagnostic Imaging, University of Calgary, Foothills Medical Centre, 1403 29th St NW, Calgary, AB, Canada T2N 2T9 (J.M.O., R.V.M., M.G.); Department of Radiology, University Hospital, LMU Munich, Munich, Germany (W.G.K.); Department of Neurosurgery, Hyogo Medical University, Nishinomiya, Japan (K.U., S.Y.); Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan (N.S.); Department of Stroke Neurology, National Hospital Organization Osaka National Hospital, Osaka, Japan (H.Y.).
Radiology. 2023 Oct;309(1):e223320. doi: 10.1148/radiol.223320.
Background The health economic benefit of endovascular treatment (EVT) in addition to best medical management for acute ischemic stroke with large ischemic core is uncertain. Purpose To assess the cost-effectiveness of EVT plus best medical management versus best medical management alone in treating acute ischemic stroke with large vessel occlusion and a baseline Alberta Stroke Program Early CT Score (ASPECTS) 3-5. Materials and Methods This is a secondary analysis of the randomized RESCUE-Japan LIMIT (Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial), with enrollment November 2018 to September 2021, in which the primary outcome was the modified Rankin Scale (mRS) score at 90 days. Participants with a baseline ASPECTS 3-5 (on the basis of noncontrast CT and diffusion-weighted imaging) were randomized 1:1 to receive EVT plus best medical management ( = 100) or best medical management alone ( = 102). The primary outcome of the current study was cost-effectiveness, determined according to the incremental cost-effectiveness ratio (ICER). A decision model consisting of a short-term component (cycle length of 3 months) and a long-term Markov state transition component (cycle length of 1 year) was used to estimate expected lifetime costs and quality-adjusted life-years (QALYs) from health care and societal perspectives in the United States. Upper and lower willingness-to-pay (WTP) thresholds were set at $100 000 and $50 000 per QALY, respectively. A deterministic one-way sensitivity analysis to determine the impact of participant age and a probabilistic sensitivity analysis to assess the impact of parameter uncertainty were conducted. Results A total of 202 participants were included in the study (mean age, 76 years ± 10 [SD]; 112 male). EVT plus best medical management resulted in ICERs of $15 743 (health care perspective) and $19 492 (societal perspective). At the lower and upper WTP thresholds, EVT was cost-effective up to 85 and 90 years (health care perspective) and 84 and 89 years (societal perspective) of age, respectively. When analyzing participants with the largest infarcts (ASPECTS 3) separately, EVT was not cost-effective (ICER, $337 072 [health care perspective] and $383 628 [societal perspective]). Conclusion EVT was cost-effective for participants with an ASPECTS 4-5, but not for those with an ASPECTS 3. ClinicalTrials.gov registration no. NCT03702413 © RSNA, 2023 See also the editorial by Widjaja in this issue.
背景 对于伴有大缺血核心的急性缺血性脑卒中患者，血管内治疗（EVT）除了最佳药物治疗以外的健康经济效益尚不确定。目的 评估 EVT 联合最佳药物治疗与单纯最佳药物治疗在治疗伴有大血管闭塞和基线 Alberta 卒中项目早期 CT 评分（ASPECTS）3-5 的急性缺血性脑卒中患者中的成本效果。材料与方法 这是一项针对随机 RESCUE-Japan LIMIT（Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial）的二次分析，于 2018 年 11 月至 2021 年 9 月入组，主要结局为 90 天时的改良 Rankin 量表（mRS）评分。基线 ASPECTS 3-5 （基于非对比 CT 和弥散加权成像）的患者被随机分为 1:1 组，分别接受 EVT 联合最佳药物治疗（ = 100）或单纯最佳药物治疗（ = 102）。本研究的主要结局为成本效果，根据增量成本效果比（ICER）确定。采用包含短期部分（3 个月周期）和长期 Markov 状态转移部分（1 年周期）的决策模型，从美国医疗保健和社会角度评估预期终身成本和质量调整生命年（QALY）。上、下意愿支付（WTP）阈值分别设定为每 QALY 100000 美元和 50000 美元。进行了确定性单因素敏感性分析，以确定患者年龄的影响，以及概率敏感性分析，以评估参数不确定性的影响。结果 共有 202 名患者纳入研究（平均年龄 76 岁 ± 10[标准差]；112 名男性）。EVT 联合最佳药物治疗的 ICER 分别为 15743 美元（医疗保健角度）和 19492 美元（社会角度）。在较低和较高的 WTP 阈值下，EVT 在 85 岁和 90 岁（医疗保健角度）和 84 岁和 89 岁（社会角度）的年龄范围内具有成本效果。当分别分析最大梗死（ASPECTS 3）的患者时，EVT 不具有成本效果（ICER 分别为 337072 美元[医疗保健角度]和 383628 美元[社会角度]）。结论 EVT 对 ASPECTS 4-5 的患者具有成本效果，但对 ASPECTS 3 的患者没有。ClinicalTrials.gov 注册号 NCT03702413 © RSNA，2023 参见本期杂志 Widjaja 的社论。
