直接经皮冠状动脉介入治疗与溶栓治疗急性 ST 段抬高型心肌梗死的成本和健康结局-瑞典早期决策再灌注研究（SWEDES）试验结果。

Cost and health outcome of primary percutaneous coronary intervention versus thrombolysis in acute ST-segment elevation myocardial infarction-Results of the Swedish Early Decision reperfusion Study (SWEDES) trial.

机构信息

Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.

出版信息

Am Heart J. 2010 Aug;160(2):322-8. doi: 10.1016/j.ahj.2010.05.008.

DOI:10.1016/j.ahj.2010.05.008

PMID:20691839

Abstract

BACKGROUND

In ST-elevation myocardial infarction, primary percutaneous coronary intervention (PCI) has a superior clinical outcome, but it may increase costs in comparison to thrombolysis. The aim of the study was to compare costs, clinical outcome, and quality-adjusted survival between primary PCI and thrombolysis.

METHODS

Patients with ST-elevation myocardial infarction were randomized to primary PCI with adjunctive enoxaparin and abciximab (n = 101), or to enoxaparin followed by reteplase (n = 104). Data on the use of health care resources, work loss, and health-related quality of life were collected during a 1-year period. Cost-effectiveness was determined by comparing costs and quality-adjusted survival. The joint distribution of incremental costs and quality-adjusted survival was analyzed using a nonparametric bootstrap approach.

RESULTS

Clinical outcome did not differ significantly between the groups. Compared with the group treated with thrombolysis, the cost of interventions was higher in the PCI-treated group ($4,602 vs $3,807; P = .047), as well as the cost of drugs ($1,309 vs $1,202; P = .001), whereas the cost of hospitalization was lower ($7,344 vs $9,278; P = .025). The cost of investigations, outpatient care, and loss of production did not differ significantly between the 2 treatment arms. Total cost and quality-adjusted survival were $25,315 and 0.759 vs $27,819 and 0.728 (both not significant) for the primary PCI and thrombolysis groups, respectively. Based on the 1-year follow-up, bootstrap analysis revealed that in 80%, 88%, and 89% of the replications, the cost per health outcome gained for PCI will be <$0, $50,000, and $100,000 respectively.

CONCLUSION

In a 1-year perspective, there was a tendency toward lower costs and better health outcome after primary PCI, resulting in costs for PCI in comparison to thrombolysis that will be below the conventional threshold for cost-effectiveness in 88% of bootstrap replications.

摘要

背景

在 ST 段抬高型心肌梗死中，直接经皮冠状动脉介入治疗（PCI）具有更优的临床结局，但与溶栓相比，它可能会增加成本。本研究旨在比较直接 PCI 与溶栓的成本、临床结局和质量调整生存。

方法

将 ST 段抬高型心肌梗死患者随机分为接受直接 PCI 联合依诺肝素和阿昔单抗治疗组（n=101）或接受依诺肝素序贯瑞替普酶治疗组（n=104）。在 1 年期间收集了有关卫生保健资源使用、工作损失和健康相关生活质量的数据。通过比较成本和质量调整生存来确定成本效益。使用非参数自举方法分析增量成本和质量调整生存的联合分布。

结果

两组的临床结局无显著差异。与溶栓治疗组相比，PCI 治疗组的干预成本更高（4602 美元 vs. 3807 美元；P=0.047），药物成本也更高（1309 美元 vs. 1202 美元；P=0.001），而住院成本更低（7344 美元 vs. 9278 美元；P=0.025）。两组在检查、门诊护理和生产损失方面的成本无显著差异。直接 PCI 和溶栓治疗组的总费用和质量调整生存分别为 25315 美元和 0.759 与 27819 美元和 0.728（均无显著差异）。基于 1 年随访，自举分析显示，在 80%、88%和 89%的复制中，PCI 每获得一个健康结果的成本将分别低于 0 美元、50000 美元和 100000 美元。