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近端深静脉血栓形成患者中,药物机械性导管定向溶栓与标准抗凝治疗的成本效益:ATTRACT试验结果

Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.

作者信息

Magnuson Elizabeth A, Chinnakondepalli Khaja, Vilain Katherine, Kearon Clive, Julian Jim A, Kahn Susan R, Goldhaber Samuel Z, Jaff Michael R, Kindzelski Andrei L, Herman Kevin, Brady Paul S, Sharma Karun, Black Carl M, Vedantham Suresh, Cohen David J

机构信息

Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).

University of Missouri-Kansas City (E.A.M., D.J.C.).

出版信息

Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005659. doi: 10.1161/CIRCOUTCOMES.119.005659. Epub 2019 Oct 8.

DOI:10.1161/CIRCOUTCOMES.119.005659
PMID:31592728
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6788761/
Abstract

BACKGROUND

In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.

METHODS AND RESULTS

Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.

CONCLUSIONS

With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.

摘要

背景

在急性深静脉血栓形成(DVT)患者中,药物机械性导管直接溶栓(PCDT)联合抗凝治疗越来越多地用于预防血栓形成后综合征。从美国医疗保健系统的角度来看,这两种治疗策略的长期成本和成本效益尚未进行比较。

方法与结果

在2009年至2014年期间,ATTRACT试验(急性静脉血栓形成:辅助导管直接溶栓清除血栓)将692例急性近端DVT患者随机分为PCDT联合抗凝治疗组(n = 337)或单纯抗凝标准治疗组(n = 355)。使用基于资源的成本核算、医院账单、医疗保险报销率和《药品话题红皮书》的组合,在24个月的随访期内评估成本(2017美元)。健康状态效用值来自简短健康调查问卷-36。试验内结果和美国生命表用于建立马尔可夫队列模型,以评估终生成本效益。对于PCDT组,初始手术的平均成本为13,600美元;与首次住院相关的每位患者成本,PCDT组为21,509美元,标准治疗组为3877美元(差值 = 17,632美元;95%CI,16,117 - 19,243美元)。24个月的成本差值为20,045美元(95%CI,16,093 - 24,120美元)。两组的效用评分在基线至6个月之间均显著增加,在任何随访时间点两组之间均无显著差异。预计终生成本差值为16,740美元,质量调整生命年(QALY)差值为0.08,PCDT的增量成本效益比为每获得1个QALY增加222,041美元。在概率敏感性分析中,PCDT实现终生增量成本效益比 < 50,000美元/QALY或 < 150,000美元/QALY的概率分别为1%和25%。对于髂股静脉DVT,PCDT带来的QALY增益更大,增量成本效益比为137,526美元/QALY;对于股腘静脉DVT,标准治疗是经济上占主导地位的策略。

结论

由于增量成本效益比 > 200,000美元/QALY,PCDT对于近端DVT不是一种经济上有吸引力的治疗方法。PCDT对于髂股静脉DVT患者可能具有中等价值。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT00790335。

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