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经导管主动脉瓣植入术与外科主动脉瓣置换术治疗症状性重度主动脉瓣狭窄的比较:一项更新的荟萃分析。

Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis.

机构信息

Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.

Department of Cardiology, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

出版信息

Eur Heart J. 2019 Oct 7;40(38):3143-3153. doi: 10.1093/eurheartj/ehz275.

Abstract

AIMS

Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the entire spectrum of surgical risk patients.

METHODS AND RESULTS

The meta-analysis is registered with PROSPERO (CRD42016037273). We identified RCTs comparing TAVI with SAVR in patients with severe aortic stenosis reporting at different follow-up periods. We extracted trial, patient, intervention, and outcome characteristics following predefined criteria. The primary outcome was all-cause mortality up to 2 years for the main analysis. Seven trials that randomly assigned 8020 participants to TAVI (4014 patients) and SAVR (4006 patients) were included. The combined mean STS score in the TAVI arm was 9.4%, 5.1%, and 2.0% for high-, intermediate-, and low surgical risk trials, respectively. Transcatheter aortic valve implantation was associated with a significant reduction of all-cause mortality compared to SAVR {hazard ratio [HR] 0.88 [95% confidence interval (CI) 0.78-0.99], P = 0.030}; an effect that was consistent across the entire spectrum of surgical risk (P-for-interaction = 0.410) and irrespective of type of transcatheter heart valve (THV) system (P-for-interaction = 0.674). Transcatheter aortic valve implantation resulted in lower risk of strokes [HR 0.81 (95% CI 0.68-0.98), P = 0.028]. Surgical aortic valve replacement was associated with a lower risk of major vascular complications [HR 1.99 (95% CI 1.34-2.93), P = 0.001] and permanent pacemaker implantations [HR 2.27 (95% CI 1.47-3.64), P < 0.001] compared to TAVI.

CONCLUSION

Compared with SAVR, TAVI is associated with reduction in all-cause mortality and stroke up to 2 years irrespective of baseline surgical risk and type of THV system.

摘要

目的

由于低危严重主动脉瓣狭窄患者的随机对照试验(RCT)提供了新证据,我们比较了经导管主动脉瓣植入术(TAVI)与外科主动脉瓣置换术(SAVR)在整个手术风险患者群体中的安全性和疗效。

方法和结果

本荟萃分析已在 PROSPERO(CRD42016037273)注册。我们确定了比较 TAVI 与 SAVR 治疗严重主动脉瓣狭窄患者的 RCT,这些 RCT 报告了不同的随访期。我们根据预设标准提取试验、患者、干预和结局特征。主要结局是主要分析中 2 年内的全因死亡率。纳入了 7 项随机分配 8020 名参与者至 TAVI(4014 名患者)和 SAVR(4006 名患者)的试验。TAVI 组的联合 STS 评分分别为高、中、低手术风险试验的 9.4%、5.1%和 2.0%。与 SAVR 相比,TAVI 可显著降低全因死亡率[风险比(HR)0.88[95%置信区间(CI)0.78-0.99],P=0.030];这种效果在整个手术风险范围内一致(P 交互=0.410),与经导管心脏瓣膜(THV)系统类型无关(P 交互=0.674)。TAVI 导致卒中和中风的风险降低[HR 0.81(95% CI 0.68-0.98),P=0.028]。与 TAVI 相比,SAVR 与较低的主要血管并发症风险[HR 1.99(95% CI 1.34-2.93),P=0.001]和永久性起搏器植入风险[HR 2.27(95% CI 1.47-3.64),P<0.001]相关。

结论

与 SAVR 相比,TAVI 可降低全因死亡率和中风风险,2 年内的结果与基线手术风险和 THV 系统类型无关。

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