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急性冠状动脉综合征患者的远程缺血预处理:一项系统评价、荟萃分析和试验序贯分析

Remote Ischemic Conditioning in Patients with Acute Coronary Syndromes: A Systematic Review with Meta-Analysis and Trial Sequential Analysis.

作者信息

Sandven Irene, Eritsland Jan, Abdelnoor Michael

机构信息

Oslo Centre for Biostatistics and Epidemiology (OCBE), Oslo University Hospital, Oslo, Norway.

Department of Cardiology, Oslo University Hospital, Oslo, Norway.

出版信息

Clin Epidemiol. 2020 Jun 10;12:595-605. doi: 10.2147/CLEP.S249785. eCollection 2020.

Abstract

OBJECTIVE

To evaluate the efficacy of remote ischemic conditioning (RIC) as compared to no conditioning on clinical endpoints in acute coronary syndromes (ACS) patients undergoing percutaneous coronary intervention (PCI).

DESIGN

Systematic review of randomized clinical trials (RCTs).

MATERIAL AND METHODS

Literature was searched up to September 13, 2019, and we identified a total of 13 RCTs. The efficacy of RIC on incidence of clinical events during follow-up was quantified by the rate ratio (RR) with its 95% confidence interval (CI), and we used fixed and random effects models to synthetize the results. Small-study effect was evaluated, and controlled for by the trim-and-fill method. Heterogeneity between studies was examined by subgroup and meta-regression analyses. The risk of false-positive results in meta-analysis was evaluated by trial sequential analysis (TSA).

RESULTS

Pooled analysis of 13 trials (7183 patients) showed that RIC compared to no conditioning revealed a non-significant risk reduction on endpoint mortality (RR=0.81, 95% CI: 0.56-1.17) during a median follow-up time of 1 year (range: 0.08-3.8) with low heterogeneity (I=16%). Controlling for small-study effect showed no efficacy of RIC (adjusted RR: 1.03, 95% CI: 0.66-1.59). Pooled effect of RIC on the incidence of myocardial infarction (MI) from 11 trials (6996 patients) was non-significant too (RR=0.85, 95% CI: 0.62-1.18), with no observed heterogeneity (I=0%) or small-study effect. A similar lack of efficacy was found in endpoint congestive heart failure (CHF) from 6 trials including 6098 patients (RR=0.71, 95% CI: 0.44-1.15), with moderate heterogeneity (I=30%). TSAs showed that the pooled estimates from the cumulative meta-analyses were true negative with adequate power.

CONCLUSION

Evidence from this updated systematic review demonstrates no beneficial effect of RIC on the incidence of clinical endpoint mortality, MI and CHF during a median follow-up of 1 year in ACS patients undergoing PCI.

摘要

目的

评估与未进行预处理相比,远程缺血预处理(RIC)对接受经皮冠状动脉介入治疗(PCI)的急性冠状动脉综合征(ACS)患者临床终点的疗效。

设计

对随机临床试验(RCT)进行系统评价。

材料与方法

检索截至2019年9月13日的文献,共纳入13项RCT。RIC对随访期间临床事件发生率的疗效通过率比(RR)及其95%置信区间(CI)进行量化,采用固定效应模型和随机效应模型综合结果。评估小研究效应,并采用剪补法进行控制。通过亚组分析和meta回归分析检验研究间的异质性。通过试验序贯分析(TSA)评估meta分析中假阳性结果的风险。

结果

对13项试验(7183例患者)的汇总分析显示,与未进行预处理相比,RIC在中位随访时间1年(范围:0.08 - 3.8年)内对终点死亡率的风险降低无显著意义(RR = 0.81,95%CI:0.56 - 1.17),异质性较低(I = 16%)。控制小研究效应后显示RIC无效(校正RR:1.03,95%CI:0.66 - 1.59)。11项试验(6996例患者)中RIC对心肌梗死(MI)发生率的汇总效应也无显著意义(RR = 0.85,95%CI:0.62 - 1.18),未观察到异质性(I = 0%)或小研究效应。在包括6098例患者的6项试验中,RIC对终点充血性心力衰竭(CHF)的疗效同样缺乏(RR = 0.71,95%CI:0.44 - 1.15),异质性中等(I = 30%)。TSA显示,累积meta分析的汇总估计为真阴性且具有足够的检验效能。

结论

本次更新的系统评价证据表明,在接受PCI的ACS患者中位随访1年期间,RIC对临床终点死亡率、MI和CHF的发生率无有益影响。

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