Department of Surgery, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Department of Surgery, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Eur J Vasc Endovasc Surg. 2022 Mar;63(3):430-437. doi: 10.1016/j.ejvs.2021.10.048. Epub 2022 Feb 9.
To compare cost effectiveness of endovascular revascularisation (ER) and supervised exercise therapy (SET) as primary treatment for patients with intermittent claudication (IC) due to iliac artery obstruction.
Cost utility analysis from a restricted societal perspective and time horizon of 12 months. Patients were included in a multicentre randomised controlled trial (SUPER study, NCT01385774, NTR2648) which compared effectiveness of ER and SET. Health status and health related quality of life (HRQOL) were measured using the Euroqol 5 dimensions 3 levels (EQ5D-3L) and VascuQol-25-NL. Incremental costs were determined per allocated treatment and use of healthcare during follow up. Effectiveness of treatment was determined in quality adjusted life years (QALYs). The difference between treatment groups was calculated by an incremental cost utility ratio (ICER).
Some 240 patients were included, and complete follow up was available for 206 patients (ER 111 , SET 95). The mean costs for patients allocated to ER were €4 031 and €2 179 for SET, a mean difference of €1 852 (95% bias corrected and accelerated [bca] bootstrap confidence interval 1 185 - 2 646). The difference in QALYs during follow up was 0.09 (95% bcaCI 0.04 - 0.13) in favour of ER. The ICER per QALY was €20 805 (95% bcaCI 11 053 - 45 561). The difference in VascuQol sumscore was 0.64 (95% bcaCI 0.39 - 0.91), again in favour of ER.
ER as a primary treatment, results in slightly better health outcome and higher QALYs and HRQOL during 12 months of follow up. Although these differences are statistically significant, clinical relevance must be discussed due to the small differences and relatively high cost of ER as primary treatment.
比较血管腔内血管重建术（ER）和监督运动疗法（SET）作为髂动脉阻塞性间歇性跛行（IC）患者的主要治疗方法的成本效益。
从受限的社会视角和 12 个月的时间范围进行成本效用分析。患者被纳入一项多中心随机对照试验（SUPER 研究，NCT01385774，NTR2648），该试验比较了 ER 和 SET 的效果。使用欧洲五维健康量表 3 级（EQ5D-3L）和 VascuQol-25-NL 测量健康状况和健康相关生活质量（HRQOL）。根据随访期间的分配治疗和医疗保健使用情况，确定增量成本。治疗效果用质量调整生命年（QALYs）来确定。通过增量成本效用比（ICER）计算治疗组之间的差异。
共纳入 240 例患者，206 例患者（ER 111 例，SET 95 例）完成了完整随访。分配给 ER 的患者的平均成本为 4031 欧元，SET 为 2179 欧元，平均差异为 1852 欧元（95%偏差校正和加速[BCA]自举置信区间为 1185 欧元至 2646 欧元）。在随访期间，ER 的 QALY 差异为 0.09（95%BCA 置信区间为 0.04 欧元至 0.13 欧元）。每 QALY 的 ICER 为 20805 欧元（95%BCA 置信区间为 11053 欧元至 45561 欧元）。VascuQol 总分的差异为 0.64（95%BCA 置信区间为 0.39 欧元至 0.91 欧元），再次有利于 ER。
作为原发性治疗，ER 在 12 个月的随访中可获得稍好的健康结果和更高的 QALYs 和 HRQOL。尽管这些差异具有统计学意义，但由于 ER 作为原发性治疗的成本相对较高且差异较小，必须讨论其临床相关性。
