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主动脉内球囊反搏支持治疗伴心原性休克心肌梗死的经济学影响:来自 IABP-SHOCK II 试验的分析。

Economic implications of intra-aortic balloon support for myocardial infarction with cardiogenic shock: an analysis from the IABP-SHOCK II-trial.

机构信息

Department of Cardiology and Pneumology, University Medical Center Göttingen, Georg-August University, Robert-Koch-Str. 40, 37075, Göttingen, Germany,

出版信息

Clin Res Cardiol. 2015 Jul;104(7):566-73. doi: 10.1007/s00392-015-0819-2. Epub 2015 Jan 31.

Abstract

BACKGROUND

The Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial has demonstrated the safety of intra-aortic balloon (IABP) support in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock, but no beneficial effect on mortality. Currently, intra-aortic balloon pumping is still the most widely used support device. However, little is known about the economic implications associated with this device.

METHODS

Data of 600 patients included in the IABP-SHOCK II trial (registered at ClinicalTrials.gov, NCT00491036) with follow-up at 30 days, 6 and 12 months were subjected to an economic analysis. Patients with cardiogenic shock complicating AMI were randomly assigned to IABP additionally to optimal medical therapy (OMT; n = 301) or OMT alone (n = 299) before early revascularization. Costs were calculated from the perspective of a German healthcare payer. Cost-effectiveness and cost-utility analyses were performed using quality-adjusted life years (QALY) and reduction in New York Heart Association (NYHA) and Canadian Cardiac Society (CCS) class as effectiveness measures.

RESULTS

There was a statistically significant difference in overall costs between the IABP (33,155 ± 14,593 ) and the control group (32,538 ± 14,031 , p < 0.00001). This was predominantly attributed to the IABP costs in the IABP (760 ± 174 ) versus control group (64 ± 218 , p < 0.0001) whilst the intensive care unit costs did not differ between the groups (29,177 ± 12,013 and 29,401 ± 12,063 , p = 0.82). There was no significant difference in QALY or NYHA and CCS reduction, respectively (p = n.s.).

CONCLUSION

IABP support is associated with higher healthcare costs as compared to conservative treatment regimens. Clinically, IABP support cannot generally be recommended in AMI complicated by cardiogenic shock in the absence of a mortality benefit. However, economically considering the relatively little contribution to overall costs generated by IABP therapy it may still be considered if clinical scenarios with an IABP-induced benefit may be identified in the future.

摘要

背景

在《主动脉内球囊泵在心原性休克 II 中的应用(IABP-SHOCK II)》试验中,已经证明了在急性心肌梗死(AMI)合并心原性休克的患者中使用主动脉内球囊(IABP)支持的安全性,但对死亡率没有有益的影响。目前,主动脉内球囊泵仍然是最广泛使用的支持设备。然而,对于这种设备的经济影响知之甚少。

方法

对《IABP-SHOCK II》试验中包含的 600 名患者的数据(在 ClinicalTrials.gov 注册,NCT00491036)进行了分析,这些患者在 30 天、6 个月和 12 个月时进行了随访。将合并 AMI 的心原性休克患者随机分配至 IABP 加最佳药物治疗(OMT;n = 301)或单独 OMT(n = 299),然后进行早期血运重建。从德国医疗支付者的角度计算成本。使用质量调整生命年(QALY)和纽约心脏协会(NYHA)和加拿大心脏协会(CCS)分级的降低作为有效性测量指标,进行成本效益和成本效用分析。

结果

IABP 组(33155 ± 14593 欧元)和对照组(32538 ± 14031 欧元)之间的总费用存在统计学上的显著差异(p < 0.00001)。这主要归因于 IABP 组的 IABP 费用(760 ± 174 欧元)高于对照组(64 ± 218 欧元,p < 0.0001),而两组的重症监护病房费用无差异(29177 ± 12013 欧元和 29401 ± 12063 欧元,p = 0.82)。QALY 或 NYHA 和 CCS 分级的降低没有显著差异(p = n.s.)。

结论

与保守治疗方案相比,IABP 支持与更高的医疗保健费用相关。从临床角度来看,如果没有死亡率的获益,IABP 支持一般不能推荐用于 AMI 合并心原性休克。然而,从经济角度考虑,IABP 治疗对总体费用的贡献相对较小,如果未来能够确定 IABP 治疗获益的临床情况,仍可以考虑使用 IABP。

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