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晕厥:晚年起搏或记录(SPRITELY)试验的成本效用分析

A Cost-Utility Analysis of the Syncope: Pacing or Recording in The Later Years (SPRITELY) Trial.

作者信息

Hofmeister Mark, Sheldon Robert S, Spackman Eldon, Raj Satish R, Talajic Mario, Becker Giuliano, Essebag Vidal, Ritchie Deborah, Morillo Carlos A, Krahn Andrew, Safdar Shahana, Maxey Connor, Clement Fiona

机构信息

Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.

Health Technology Assessment Unit, O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.

出版信息

CJC Open. 2022 Mar 29;4(7):617-624. doi: 10.1016/j.cjco.2022.03.009. eCollection 2022 Jul.

Abstract

BACKGROUND

The yncope: acing or ecording n hater ears (SPRITELY) trial reported that a strategy of empiric permanent pacing in patients with syncope and bifascicular block reduces major adverse events more effectively than acting on the results of an implantable cardiac monitor (ICM). Our objective was to determine the cost-effectiveness of using the ICM, compared with a pacemaker (PM), in the management of older adults (age > 50 years) with bifascicular block and syncope enrolled in the SPRITELY trial.

METHODS

SPRITELY was a pragmatic, open-label randomized controlled trial with a median follow-up of 33 months. The primary outcome of this analysis is the cost per additional quality-adjusted life-year (QALY). Resource utilization and utility data were collected prospectively, and outcomes at 2 years were compared between the 2 arms. A decision analytic model simulated a 3-year time horizon.

RESULTS

The mean cost incurred by participants randomized to the PM arm was $9918, compared to $15,416 (both in Canadian dollars) for participants randomized to the ICM arm. The ICM strategy resulted in 0.167 QALYs fewer than the PM strategy. Cost and QALY outcomes are sensitive to the proportion of participants randomized to the ICM arm who subsequently required PM insertion. In 40,000 iterations of probabilistic sensitivity analysis, the PM strategy resulted in cost-savings in 99.7% of iterations, compared with the ICM strategy.

CONCLUSIONS

The PM strategy was dominant-that is, less costly and estimated to result in a greater number of QALYs. For patients with unexplained syncope, bifascicular block, and age > 50 years, a PM is more likely to be cost-effective than an ICM.

摘要

背景

晕厥和双分支阻滞患者经验性永久起搏(SPRITELY)试验报告称,与根据植入式心脏监测器(ICM)结果采取行动相比,晕厥和双分支阻滞患者的经验性永久起搏策略能更有效地减少主要不良事件。我们的目标是确定在SPRITELY试验中纳入的双分支阻滞和晕厥的老年人(年龄>50岁)管理中,与起搏器(PM)相比,使用ICM的成本效益。

方法

SPRITELY是一项务实的、开放标签的随机对照试验,中位随访时间为33个月。该分析的主要结果是每增加一个质量调整生命年(QALY)的成本。前瞻性收集资源利用和效用数据,并比较两组在2年时的结果。一个决策分析模型模拟了3年的时间范围。

结果

随机分配到PM组的参与者的平均成本为9918美元,而随机分配到ICM组的参与者的平均成本为(均为加元)15416美元。ICM策略导致的QALY比PM策略少0.16个。成本和QALY结果对随机分配到ICM组且随后需要植入PM的参与者比例敏感。在40000次概率敏感性分析迭代中,与ICM策略相比,PM策略在99.7%的迭代中节省了成本。

结论

PM策略占主导地位,即成本更低,估计能带来更多的QALY。对于不明原因晕厥、双分支阻滞且年龄>50岁的患者,PM比ICM更有可能具有成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb51/9294989/3fc56d617f8f/gr1.jpg

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