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Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients for the Treatment of Severe Aortic Stenosis

机译:低风险患者经导管与手术主动脉瓣置换术治疗严重主动脉瓣狭窄

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摘要

Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33–0.95; = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42–1.07; = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17–0.39; < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14–0.65; < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14–0.58; = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31–11.99; = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33–9.07; = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41–1.25; = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53–1.83; = 0.96), and MI (RR = 0.75; 95% CI 0.43–1.29; = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.
机译:最近,两项随机试验(PARTNER 3和Evolut低风险试验)独立地证明,经导管主动脉瓣置换术(TAVR)在治疗低手术率患者中的严重主动脉瓣狭窄方面不逊于手术主动脉瓣膜置换术(SAVR)。风险,为逐步将临床适应症扩展至TAVR铺平了道路。我们设计了一项荟萃分析,以比较具有低手术风险的严重主动脉瓣狭窄患者的TAVR与SAVR。该研究方案已在PROSPERO(CRD42019131125)中注册。在Medline,Scholar和Scopus电子数据库中搜索比较TAVR或SAVR一年结局的随机研究。总共选择了三项随机研究,包括近3000名患者。一年后,与SAVR相比,TAVR可使心血管死亡的风险显着降低(风险比(RR)= 0.56; 95%CI 0.33-0.95; = 0.03)。相反,两组间一年全因死亡率无差异(RR = 0.67; 95%CI 0.42-1.07; = 0.10)。在次要终点中,与SAVR相比,接受TAVR的患者发生新发房颤的风险较低(RR = 0.26; 95%CI 0.17-0.39; <0.00001),有大出血(RR = 0.30; 95%CI 0.14-0.65) ; <0.002)和II或III期急性肾损伤(RR = 0.28; 95%CI 0.14-0.58; = 0.0005)。相反,与SAVR相比,TAVR与主动脉瓣反流(RR = 3.96; 95%CI 1.31–11.99; = 0.01)和永久起搏器植入的风险更高(RR = 3.47; 95%CI 1.33–9.07; = 0.01)。在卒中风险(RR = 0.71; 95%CI 0.41–1.25; = 0.24),短暂性脑缺血发作(TIA; RR = 0.98; 95%CI 0.53–1.83; = 0.96)和风险之间,两组之间没有差异。 MI(RR = 0.75; 95%CI 0.43-1.29; = 0.29)。总之,目前的荟萃分析(包括三项随机研究和近3000例具有低手术风险的严重主动脉瓣狭窄患者)显示,与SAVR相比,在一年的随访中,TAVR与较低的CV死亡相关。尽管如此,瓣周主动脉瓣关闭不全和起搏器植入仍是两个需要解决的弱点。

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