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机械循环支持联合 Impella 或主动脉内球囊泵在高危经皮冠状动脉介入治疗和/或心源性休克中的安全性和疗效:来自随机试验网络荟萃分析的见解。

Safety and efficacy of mechanical circulatory support with Impella or intra-aortic balloon pump for high-risk percutaneous coronary intervention and/or cardiogenic shock: Insights from a network meta-analysis of randomized trials.

机构信息

Department of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, New York.

Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan.

出版信息

Catheter Cardiovasc Interv. 2021 Apr 1;97(5):E636-E645. doi: 10.1002/ccd.29236. Epub 2020 Sep 7.

Abstract

BACKGROUND

Mechanical circulatory support (MCS) with Impella or intra-aortic balloon pump (IABP) is used for high-risk percutaneous coronary intervention (PCI) and/or for cardiogenic shock (CS) due to acute myocardial infarction. We aimed to investigate the efficacy and safety of Impella or IABP when compared with no MCS using a network meta-analysis of randomized controlled trials (RCTs).

METHODS

EMBASE and MEDLINE were searched through February 2020 for RCT evaluating efficacy of Impella vs. IABP vs. no MCS in patients undergoing high-risk PCI or CS. The primary efficacy outcome was 30 day or in-hospital all-cause mortality whereas the primary safety outcomes were major bleeding and vascular complications.

RESULTS

Our search identified nine RCTs enrolling a total of 1,996 patients with high-risk PCI and/or CS. There was no significant difference with Impella or IABP on all-cause mortality when compared with no MCS (Impella vs. no MCS; OR:0.82 [0.35-1.90], p = .65, IABP vs. no MCS; OR:0.77 [0.47-1.28], p = .31, I = 18.1%). Impella significantly increased major bleeding compared with no MCS (Impella vs. no MCS; OR:7.01 [1.11-44.4], p = .038, I = 19.2%). IABP did not increase the risk of major bleeding compared with no MCS (OR:1.27 [0.75-2.16], p = .38, I = 19.2%) but increased vascular complication compared with no MCS (OR:1.92 [1.01-3.64], p = .045, I = 1.5%).

CONCLUSIONS

Neither Impella nor IABP decreased all-cause short-term mortality when compared with no MCS for high-risk PCI and/or CS. Moreover, Impella increased major bleeding compared with no MCS.

摘要

背景

机械循环支持(MCS)联合 Impella 或主动脉内球囊泵(IABP)用于高危经皮冠状动脉介入治疗(PCI)和/或急性心肌梗死引起的心源性休克(CS)。我们旨在通过对随机对照试验(RCT)的网络荟萃分析,研究 Impella 或 IABP 与不使用 MCS 相比的疗效和安全性。

方法

通过 EMBASE 和 MEDLINE 检索,评估高危 PCI 或 CS 患者中 Impella 与 IABP 与不使用 MCS 比较的疗效的 RCT,截止日期为 2020 年 2 月。主要疗效结局为 30 天或住院全因死亡率,主要安全性结局为大出血和血管并发症。

结果

我们的检索共纳入了 9 项 RCT,共纳入了 1996 例高危 PCI 和/或 CS 患者。与不使用 MCS 相比,使用 Impella 或 IABP 并未降低全因死亡率(Impella 与不使用 MCS;OR:0.82 [0.35-1.90],p =.65,IABP 与不使用 MCS;OR:0.77 [0.47-1.28],p =.31,I = 18.1%)。与不使用 MCS 相比,Impella 显著增加了大出血的风险(Impella 与不使用 MCS;OR:7.01 [1.11-44.4],p =.038,I = 19.2%)。IABP 与不使用 MCS 相比并未增加大出血的风险(OR:1.27 [0.75-2.16],p =.38,I = 19.2%),但增加了血管并发症的风险(OR:1.92 [1.01-3.64],p =.045,I = 1.5%)。

结论

对于高危 PCI 和/或 CS,与不使用 MCS 相比,Impella 或 IABP 并未降低短期全因死亡率。此外,与不使用 MCS 相比,Impella 增加了大出血的风险。

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