医学
阀门更换
心脏病学
主动脉瓣置换术
狭窄
内科学
冲程(发动机)
临床终点
反流(循环)
主动脉瓣狭窄
主动脉瓣
血流动力学
外科
随机对照试验
机械工程
工程类
作者
Mahesh V. Madhavan,Susheel Kodali,Vinod H. Thourani,Raj Makkar,Michael J. Mack,Samir Kapadia,John G. Webb,David J. Cohen,Howard C. Herrmann,Mathew Williams,Kevin L. Greason,Philippe Pîbarot,Rebecca T. Hahn,Wael A. Jaber,Ke Xu,Maria Alu,Craig R. Smith,Martin B. Leon
标识
DOI:10.1016/j.jacc.2023.04.049
摘要
Previous studies demonstrated transcatheter aortic valve replacement (TAVR) with an earlier generation balloon-expandable valve to be noninferior to surgical aortic valve replacement (SAVR) for death and disabling stroke in intermediate-risk patients with symptomatic, severe aortic stenosis at 5 years. However, limited long-term data are available with the more contemporary SAPIEN 3 (S3) bioprosthesis. The aim of this study was to compare 5-year risk-adjusted outcomes in intermediate-risk patients undergoing S3 TAVR vs SAVR. Propensity score matching was performed to account for baseline differences in intermediate-risk patients undergoing S3 TAVR in the PARTNER 2 (Placement of Aortic Transcatheter Valves) S3 single-arm study and SAVR in the PARTNER 2A randomized clinical trial. The primary composite endpoint consisted of 5-year all-cause death and disabling stroke. A total of 783 matched pairs of intermediate-risk patients with severe aortic stenosis were studied. There were no differences in the primary endpoint between S3 TAVR and SAVR at 5 years (40.2% vs 42.7%; HR: 0.87; 95% CI: 0.74-1.03; P = 0.10). The incidence of mild or greater paravalvular regurgitation was more common after S3 TAVR. There were no differences in structural valve deterioration–related stage 2 and 3 hemodynamic valve deterioration or bioprosthetic valve failure. In this propensity-matched analysis of intermediate-risk patients, 5-year rates of death and disabling stroke were similar between S3 TAVR and SAVR. Rates of structural valve deterioration–related hemodynamic valve deterioration were similar, but paravalvular regurgitation was more common after S3 TAVR. Longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability. (PII S3i [PARTNER II Trial: Placement of Aortic Transcatheter Valves II – S3 Intermediate], NCT03222128; PII A (PARTNER II Trial: Placement of Aortic Transcatheter Valves II – XT Intermediate and High Risk], NCT01314313)
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