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低手术风险患者经导管主动脉瓣置换术与外科主动脉瓣置换术的比较:随机试验和倾向评分匹配观察性研究的荟萃分析

Transcatheter versus surgical aortic valve replacement in patients at low surgical risk: A meta-analysis of randomized trials and propensity score matched observational studies.

作者信息

Witberg Guy, Lador Adi, Yahav Dafna, Kornowski Ran

机构信息

Department of Cardiology, Rabin medical center, Petach, Tikva, Israel.

Sackler Faculty of Medicine, Tel-Aviv university, Tel, Aviv, Israel.

出版信息

Catheter Cardiovasc Interv. 2018 Aug 1;92(2):408-416. doi: 10.1002/ccd.27518. Epub 2018 Feb 1.

DOI:10.1002/ccd.27518
PMID:29388308
Abstract

BACKGROUND

Although transcatheter aortic valve replacement (TAVR) is officially indicated for high risk aortic stenosis (AS) patients, the procedure is increasingly being performed in patients who are not at high surgical risk, including a substantial number of low risk patients. However, data on the benefit of TAVR in this patient population is limited.

METHODS

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies with propensity score matching (PSM) of TAVR versus surgical aortic valve replacement (SAVR) in patients who are at low surgical risk. The primary outcome was all-cause mortality. The secondary outcomes included stroke, myocardial infarction, bleeding, and various procedural complications.

RESULTS

Six studies (2 RCTs and 4 PSM studies) totaling 3,484 patients were included. Follow-up ranged from 3 months to 3 years (median 2 years). The short-term mortality was similar with either TAVR or SAVR (2.2% for TAVR and 2.6% for SAVR, RR 0.89, 95% CI 0.56-1.41, P = 0.62), however, TAVR was associated with increased risk for intermediate-term mortality (17.2% for TAVR and 12.7% for SAVR, RR 1.45, 95% CI 1.11-1.89, P = 0.006). In terms of periprocedural complications, TAVR was associated with reduced risk for bleeding and renal failure and an increase in vascular complications and Pacemaker implantation.

CONCLUSIONS

In patients who are at low surgical risk, TAVR seems to be associated with increased mortality risk. Until more data in this population is available, SAVR should remain the treatment of choice for these patients.

摘要

背景

尽管经导管主动脉瓣置换术(TAVR)已被正式批准用于高危主动脉瓣狭窄(AS)患者,但该手术越来越多地应用于手术风险不高的患者,包括大量低风险患者。然而,关于TAVR在这一患者群体中的益处的数据有限。

方法

我们对低手术风险患者中TAVR与外科主动脉瓣置换术(SAVR)的随机对照试验(RCT)和倾向评分匹配(PSM)观察性研究进行了系统评价和荟萃分析。主要结局是全因死亡率。次要结局包括中风、心肌梗死、出血和各种手术并发症。

结果

纳入了6项研究(2项RCT和4项PSM研究),共3484例患者。随访时间为3个月至3年(中位时间2年)。TAVR和SAVR的短期死亡率相似(TAVR为2.2%,SAVR为2.6%,RR 0.89,95%CI 0.56-1.41,P = 0.62),然而,TAVR与中期死亡率风险增加相关(TAVR为17.2%,SAVR为12.7%,RR 1.45,95%CI 1.11-1.89,P = 0.006)。在围手术期并发症方面,TAVR与出血和肾衰竭风险降低以及血管并发症和起搏器植入增加相关。

结论

在手术风险低的患者中,TAVR似乎与死亡风险增加相关。在获得该人群更多数据之前,SAVR仍应是这些患者的首选治疗方法。

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