Koopman Miou S, Hoving Jan W, van Voorst Henk, Daems Jasper D, Peerlings Daan, Buskens Erik, Lingsma Hester F, Marquering Henk A, de Jong Hugo Wam, Berkhemer Olvert A, van Zwam Wim H, van Walderveen Marianne Aa, van den Wijngaard Ido, van der Lugt Aad, Dippel Diederik Wj, Yoo Albert J, Campbell Bruce Cv, Kunz Wolfgang G, Majoie Charles Blm, Emmer Bart J
Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Department of Biomedical Engineering and Physics, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Eur Stroke J. 2022 Jun;7(2):188-197. doi: 10.1177/23969873221092535. Epub 2022 Apr 21.
Computed tomography perfusion (CTP) is variably considered to assess eligibility for endovascular thrombectomy (EVT) in acute ischemic (AIS) stroke patients. Although CTP is recommended for patient selection in later (6-24 h) time window, it is currently not recommended in the earlier (0-6 h) time window and the costs and health effects of including CTP for EVT selection remain unknown. We aim to estimate the costs and health effects of using CTP for EVT selection in AIS patients compared to conventional selection.
CLEOPATRA is a healthcare evaluation study using clinical and imaging data from multiple, prospective EVT trials and registries in both the earlier and later time windows. To study the long-term health and cost effects, we will construct a ("Markov") health state transition model simulating the clinical outcome over a 5-year follow-up period for CTP-based and conventional selection for EVT. Clinical data acquired within the current study and estimates from the literature will be used as input for probabilities of events, costs, and Quality-Adjusted Life Years (QALYs) per modified Rankin Scale (mRS) subscore. Primary outcome for the cost-effectiveness analysis will be the Incremental Cost-Effectiveness Ratio (ICER) in terms of costs per QALY gained over the simulated follow-up period.
Outcome measures will be reported as cumulative values over a 5-year follow-up period.
This study will provide preliminary insight into costs and health effects of including CTP in the selection for EVT for AIS patients, presenting between 0 and 24 h after time last known well. The results may be used to develop recommendations and inform further implementation projects and studies.
计算机断层扫描灌注成像（CTP）在评估急性缺血性卒中（AIS）患者血管内血栓切除术（EVT）的适用性方面存在不同看法。尽管推荐在较晚（6 - 24小时）时间窗内使用CTP进行患者选择，但目前不建议在较早（0 - 6小时）时间窗内使用，且将CTP纳入EVT选择的成本和对健康的影响仍不明确。我们旨在估计与传统选择相比，在AIS患者中使用CTP进行EVT选择的成本和对健康的影响。
CLEOPATRA是一项医疗保健评估研究，使用了来自多个前瞻性EVT试验和登记处的早期和晚期时间窗的临床和影像数据。为研究长期健康和成本影响，我们将构建一个（“马尔可夫”）健康状态转换模型，模拟基于CTP和传统EVT选择的5年随访期内的临床结局。本研究中获取的临床数据以及文献估计值将用作事件概率、成本和每个改良Rankin量表（mRS）子评分的质量调整生命年（QALY）的输入。成本效益分析的主要结局将是在模拟随访期内每获得一个QALY的增量成本效益比（ICER）。
结局指标将报告为5年随访期内的累积值。
本研究将初步深入了解在最后一次已知良好状态后0至24小时内的AIS患者中，将CTP纳入EVT选择的成本和对健康的影响。研究结果可用于制定建议，并为进一步的实施项目和研究提供参考。
