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经导管主动脉瓣植入术与其他方法治疗主动脉瓣狭窄的比较:系统评价和荟萃分析。

Comparison of transcatheter aortic valve implantation with other approaches to treat aortic valve stenosis: a systematic review and meta-analysis.

机构信息

Department for Evidence-based Medicine and Clinical Epidemiology, Danube University Krems, Dr.-Karl-Dorrek-Straße 30, 3500, Krems, Austria.

Division of Interventional Angiology, University Hospital Leipzig, Liebigstraße 20, Haus 4, 04103, Leipzig, Germany.

出版信息

Syst Rev. 2019 Feb 5;8(1):44. doi: 10.1186/s13643-019-0954-3.

Abstract

BACKGROUND

Transcatheter aortic valve replacement (TAVI) is an alternative treatment for patients with symptomatic severe aortic stenosis ineligible for surgical aortic valve replacement (SAVR) or at increased perioperative risk. Due to continually emerging evidence, we performed a systematic review and meta-analysis comparing benefits and harms of TAVI, SAVR, medical therapy, and balloon aortic valvuloplasty.

METHODS

We searched MEDLINE, Embase, and Cochrane CENTRAL from 2002 to June 6, 2017. We dually screened abstracts and full-text articles for randomized controlled trials (RCTs) and propensity score-matched observational studies. Two investigators independently rated the risk of bias of included studies and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). If data permitted, we performed meta-analyses using random- and fixed-effects models.

RESULTS

Out of 7755 citations, we included six RCTs (5862 patients) and 13 observational studies (6376 patients). In meta-analyses, patients treated with SAVR or TAVI had similar risks for mortality at 30 days (relative risk [RR] 1.05; 95% confidence interval [CI] 0.82 to 1.33) and 1 year (RR 1.02; 95% CI 0.93 to 1.13). TAVI had significantly lower risks for major bleeding but increased risks for major vascular complications, moderate or severe paravalvular aortic regurgitation, and new pacemaker implantation compared to SAVR. Comparing TAVI to medical therapy, mortality did not differ at 30 days but was significantly reduced at 1 year (RR 0.51; 95% CI 0.34 to 0.77).

CONCLUSIONS

Given similar mortality risks but different patterns of adverse events, the choice between TAVI and SAVR remains an individual one.

摘要

背景

经导管主动脉瓣置换术(TAVI)是一种替代治疗方法,适用于因手术主动脉瓣置换术(SAVR)禁忌或围手术期风险增加而不适合接受 SAVR 的有症状严重主动脉瓣狭窄患者。由于不断出现新的证据,我们对 TAVI、SAVR、药物治疗和球囊主动脉瓣成形术的疗效和危害进行了系统评价和荟萃分析。

方法

我们检索了 2002 年至 2017 年 6 月 6 日的 MEDLINE、Embase 和 Cochrane CENTRAL。我们对随机对照试验(RCT)和倾向评分匹配的观察性研究的摘要和全文文章进行了双重筛选。两名调查员独立评估纳入研究的偏倚风险,并使用 GRADE(推荐评估、制定与评价分级)确定证据质量。如果数据允许,我们使用随机和固定效应模型进行荟萃分析。

结果

在 7755 条引文当中,我们纳入了 6 项 RCT(5862 例患者)和 13 项观察性研究(6376 例患者)。在荟萃分析中,接受 SAVR 或 TAVI 治疗的患者在 30 天(相对风险 [RR] 1.05;95%置信区间 [CI] 0.82 至 1.33)和 1 年(RR 1.02;95% CI 0.93 至 1.13)的死亡率相似。与 SAVR 相比,TAVI 具有显著较低的大出血风险,但较大血管并发症、中度或重度瓣周漏、新植入起搏器的风险增加。与药物治疗相比,TAVI 在 30 天的死亡率没有差异,但在 1 年时显著降低(RR 0.51;95% CI 0.34 至 0.77)。

结论

鉴于相似的死亡率风险,但不良事件模式不同,TAVI 和 SAVR 之间的选择仍然是个体化的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba03/6362570/0df5557814d6/13643_2019_954_Fig1_HTML.jpg

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