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经皮冠状动脉介入治疗后使用止血装置(血管塞和缝合装置)经桡动脉入路与经股动脉入路的安全性比较:系统评价和荟萃分析。

Safety of transradial access compared to transfemoral access with hemostatic devices (vessel plugs and suture devices) after percutaneous coronary interventions: A systematic review and meta-analysis.

机构信息

Mount Sinai St Luke's, Roosevelt Hospital, New York, New York.

Rhode Island Hospital, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

出版信息

Catheter Cardiovasc Interv. 2020 Aug;96(2):285-295. doi: 10.1002/ccd.29061. Epub 2020 Jun 10.

Abstract

OBJECTIVES

Comparing the safety of transradial access (TRA) and conventional hemostasis with transfemoral access (TFA) and vascular closure devices (vessel plugs and suture devices) in patients undergoing percutaneous coronary interventions.

BACKGROUND

TRA for PCIs is associated with fewer bleeding and vascular complications compared with TFA. Vascular closure devices (VCD) are often used post TFA to establish early hemostasis and mitigate bleeding risk. However, the comparative efficacy of TRA and TFA with VCDs remains controversial.

METHOD

Electronic database were systematically searched for all pertinent studies from inception through January 2020. Randomized studies, registry data, and abstracts published in peer-reviewed indexed journals were included. The short-term outcomes: major bleeding, vascular complications, and closure device failure were evaluated. Random-effects model was used to pool individual study results.

RESULTS

Twelve studies (8 observational, 4 randomized) including 7,961 patients (TRA: 3,121 patients, TFA and vessel plugs: 3,157 patients, TFA & suture devices: 1,683 patients) were included in the analysis. Major bleeding was significantly lower with TRA compared with TFA and vessel plugs (odds ratio [OR] 0.22, 95%CI 0.11-0.44, p < .00001) and TFA & suture devices (OR 0.12, 95%CI 0.05-0.28, p < .00001). Vascular complications were significantly lower with TRA compared to TFA and vessel plugs (OR 0.25, 95%CI 0.13-0.49, p < .0001) and TFA & suture devices (OR 0.13, 95%CI 0.04-0.41, p = 0.0005). Rates of closure device failure were lower for TRA compared to TFA & suture devices (OR 0.13, 95%CI 0.04-0.41, p = .0005), but similar to TFA & vessel plugs (OR 0.23, 95%CI 0.01-4.28, p = .33), although confidence intervals were wide. All analysis revealed a low to moderate level of heterogeneity.

CONCLUSION

TRA with conventional hemostasis is safer than TFA with hemostasis via vessel plugs or suture devices and should be considered best practice.

摘要

目的

比较经皮冠状动脉介入治疗中经桡动脉入路(TRA)与传统股动脉入路(TFA)和血管闭合装置(血管塞和缝合器)的安全性。

背景

与 TFA 相比,TRA 行 PCI 相关的出血和血管并发症更少。血管闭合装置(VCD)常用于 TFA 后以实现早期止血和降低出血风险。然而,TRA 与 TFA 联合 VCD 的疗效比较仍存在争议。

方法

系统检索了从开始到 2020 年 1 月的所有相关研究的电子数据库。纳入随机研究、注册数据和同行评议索引期刊上发表的摘要。评估短期结局:主要出血、血管并发症和闭合装置失败。使用随机效应模型汇总个体研究结果。

结果

纳入了 12 项研究(8 项观察性研究,4 项随机研究),共 7961 例患者(TRA:3121 例,TFA 和血管塞:3157 例,TFA 和缝合器:1683 例)。与 TFA 和血管塞相比,TRA 显著降低了主要出血风险(比值比 [OR] 0.22,95%CI 0.11-0.44,p<0.00001)和 TFA 和缝合器(OR 0.12,95%CI 0.05-0.28,p<0.00001)。TRA 与 TFA 和血管塞相比,血管并发症发生率显著降低(OR 0.25,95%CI 0.13-0.49,p<0.0001)和 TFA 和缝合器(OR 0.13,95%CI 0.04-0.41,p=0.0005)。TRA 与 TFA 和缝合器相比,闭合装置失败的发生率较低(OR 0.13,95%CI 0.04-0.41,p=0.0005),但与 TFA 和血管塞相似(OR 0.23,95%CI 0.01-4.28,p=0.33),尽管置信区间较宽。所有分析均显示存在低至中度异质性。

结论

经桡动脉入路联合常规止血比股动脉入路联合血管塞或缝合器止血更安全,应作为最佳治疗选择。

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