大核心梗死性卒中患者的血管内血栓切除术：SELECT 研究的成本效益分析。
Endovascular thrombectomy in patients with large core ischemic stroke: a cost-effectiveness analysis from the SELECT study.
机构信息
Neurology, University of Texas McGovern Medical School, Houston, Texas, USA
Department of Applied Health Research, University College London, London, UK.
出版信息
J Neurointerv Surg. 2021 Oct;13(10):875-882. doi: 10.1136/neurintsurg-2020-016766. Epub 2020 Nov 13.
BACKGROUND
It is unknown whether endovascular thrombectomy (EVT) is cost effective in large ischemic core infarcts.
METHODS
In the prospective, multicenter, cohort study of imaging selection study (SELECT), large core was defined as computed tomography (CT) ASPECTS<6 or computed tomography perfusion (CTP) ischemic core volume (rCBF<30%) ≥50 cc. A Markov model estimated costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) of EVT compared with medical management (MM) over lifetime. The willingness to pay (WTP) per QALY was set at $50 000 and $100 000 and the net monetary benefits (NMB) were calculated. Probabilistic sensitivity analysis (PSA) and cost-effectiveness acceptability curves (CEAC) for EVT were assessed in SELECT and other pivotal trials.
RESULTS
From 361 patients enrolled in SELECT, 105 had large core on CT or CTP (EVT 62, MM 43). 19 (31%) EVT vs 6 (14%) MM patients achieved modified Rankin Scale (mRS) score 0-2 (OR 3.27, 95% CI 1.11 to 9.62, P=0.03) with a shift towards better mRS (cOR 2.12, 95% CI 1.05 to 4.31, P=0.04). Over the projected lifetime of patients presenting with large core, EVT led to incremental costs of $33 094 and a gain of 1.34 QALYs per patient, resulting in ICER of $24 665 per QALY. EVT has a higher NMB compared with MM at lower (EVT -$42 747, MM -$76 740) and upper (EVT $155 041, MM $57 134) WTP thresholds. PSA confirmed the results and CEAC showed 77% and 92% acceptability of EVT at the WTP of $50 000 and $100 000, respectively. EVT was associated with an increment of $29 225 in societal costs. The pivotal EVT trials (HERMES, DAWN, DEFUSE 3) were dominant in a sensitivity analysis at the same inputs, with societal cost-savings of $37 901, $86 164 and $22 501 and a gain of 1.62, 2.36 and 2.21 QALYs, respectively.
CONCLUSIONS
In a non-randomized prospective cohort study, EVT resulted in better outcomes in large core patients with higher QALYs, NMB and high cost-effectiveness acceptability rates at current WTP thresholds. Randomized trials are needed to confirm these results.
CLINICAL TRIAL REGISTRATION
NCT02446587.
背景
目前尚不清楚血管内血栓切除术（EVT）在大核心梗死中是否具有成本效益。
方法
在前瞻性、多中心、影像学选择研究（SELECT）的队列研究中，大核心定义为计算机断层扫描（CT）ASPECTS<6 或计算机断层灌注（CTP）缺血核心体积（rCBF<30%）≥50cc。Markov 模型估计了 EVT 与药物治疗（MM）相比在终身内的成本、质量调整生命年（QALYs）和增量成本效益比（ICER）。意愿支付（WTP）每 QALY 的设定为 50000 美元和 100000 美元，计算净货币收益（NMB）。在 SELECT 和其他关键试验中评估了 EVT 的概率敏感性分析（PSA）和成本效益接受曲线（CEAC）。
结果
从 361 名入选 SELECT 的患者中，有 105 名患者 CT 或 CTP 存在大核心（EVT 62 例，MM 43 例）。19 名（31%）EVT 患者和 6 名（14%）MM 患者达到改良 Rankin 量表（mRS）评分 0-2（OR 3.27，95%CI 1.11-9.62，P=0.03），mRS 评分改善（cOR 2.12，95%CI 1.05-4.31，P=0.04）。在大核心患者的预期寿命内，EVT 导致每位患者的增量成本为 33094 美元，QALY 增加 1.34，导致 EVT 的增量成本效益比为每 QALY 24665 美元。EVT 的 NMB 高于 MM 在较低（EVT -42747 美元，MM -76740 美元）和较高（EVT 155041 美元，MM 57134 美元）的 WTP 阈值。PSA 证实了这些结果，CEAC 显示在 50000 美元和 100000 美元的 WTP 下，EVT 的接受率分别为 77%和 92%。EVT 与社会成本增加 29225 美元相关。关键的 EVT 试验（HERMES、DAWN、DEFUSE 3）在相同输入条件下的敏感性分析中具有优势，社会成本节约分别为 37901 美元、86164 美元和 22501 美元，分别增加 1.62、2.36 和 2.21 QALYs。
结论
在一项非随机前瞻性队列研究中，EVT 在大核心梗死患者中取得了更好的结果，具有更高的 QALYs、NMB 和较高的 WTP 阈值成本效益接受率。需要随机试验来证实这些结果。
临床试验注册
NCT02446587。
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