Polimeni Alberto, Sorrentino Sabato, De Rosa Salvatore, Spaccarotella Carmen, Mongiardo Annalisa, Sabatino Jolanda, Indolfi Ciro
Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, 88100 Catanzaro, Italy.
URT-CNR, Department of Medicine, Consiglio Nazionale delle Ricerche, 88100 Catanzaro, Italy.
J Clin Med. 2020 Feb 6;9(2):439. doi: 10.3390/jcm9020439.
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.
最近,两项随机试验,即PARTNER 3试验和Evolut低风险试验,独立证明经导管主动脉瓣置换术(TAVR)在治疗手术风险较低的严重主动脉瓣狭窄患者方面不劣于外科主动脉瓣置换术(SAVR),为TAVR临床适应证的逐步扩大铺平了道路。我们设计了一项荟萃分析,以比较TAVR与SAVR在手术风险较低的严重主动脉瓣狭窄患者中的疗效。该研究方案已在PROSPERO(CRD42019131125)注册。在Medline、Scholar和Scopus电子数据库中检索比较TAVR或SAVR一年结局的随机研究。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的心血管死亡风险显著降低(风险比(RR)=0.56;95%置信区间0.33 - 0.95;P = 0.03)。相反,两组之间的一年全因死亡率无差异(RR = 0.67;95%置信区间0.42 - 1.07;P = 0.10)。在次要终点中,与SAVR相比,接受TAVR的患者新发房颤风险较低(RR = 0.26;95%置信区间0.17 - 0.39;P < 0.00001)、大出血风险较低(RR = 0.30;95%置信区间0.14 - 0.65;P < 0.002)以及急性肾损伤II期或III期风险较低(RR = 0.28;95%置信区间0.14 - 0.58;P = 0.0005)。相反,与SAVR相比,TAVR与更高的主动脉瓣反流风险(RR = 3.96;95%置信区间1.31 - 11.99;P = 0.01)和永久性起搏器植入风险(RR = 3.47;95%置信区间1.33 - 9.07;P = 0.01)相关。两组在中风风险(RR = 0.71;95%置信区间0.41 - 1.25;P = 0.24)、短暂性脑缺血发作(TIA;RR = 0.98;95%置信区间0.53 - 1.83;P = 0.96)和心肌梗死(RR = 0.75;95%置信区间0.43 - 1.29;P = 0.29)方面未观察到差异。总之,本荟萃分析包括三项随机研究和近3000名手术风险较低的严重主动脉瓣狭窄患者,结果显示在一年随访中,与SAVR相比,TAVR与较低的心血管死亡相关。然而,瓣周主动脉瓣反流和起搏器植入仍然是两个需要解决的薄弱环节。