PARTNER-2 试验中经导管主动脉瓣与外科主动脉瓣生物假体的结构性衰退。
Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial.
机构信息
Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.
Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.
出版信息
J Am Coll Cardiol. 2020 Oct 20;76(16):1830-1843. doi: 10.1016/j.jacc.2020.08.049.
BACKGROUND
It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD.
OBJECTIVES
This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry.
METHODS
In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years.
RESULTS
Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts.
CONCLUSIONS
Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).
背景
经导管瓣膜的耐久性是否与外科生物瓣相当尚不清楚。基于瓣膜相关再介入或死亡的结构性瓣膜衰败（SVD）定义低估了 SVD 的发生率。
目的
本研究旨在通过基于瓣膜功能超声心动图随访的新的标准化定义，确定并比较中危重度主动脉瓣狭窄患者接受经导管主动脉瓣置换术（TAVR）或外科主动脉瓣置换术（SAVR）后 5 年 SVD 的发生率，该患者来自 PARTNER（主动脉瓣经导管置换术）2A 试验和注册研究。
方法
PARTNER 2A 试验中，患者被随机分配接受 SAPIEN XT 经导管主动脉瓣置换术或 SAVR；而在 SAPIEN 3 注册研究中，患者被分配接受 SAPIEN 3 经导管主动脉瓣置换术。主要终点是 SVD 的发生率，即超声心动图随访期间 SVD 相关血流动力学瓣膜恶化和/或 5 年时 SVD 相关生物瓣失效（BVF）的复合发生率。
结果
与 SAVR 相比，SAPIEN-XT TAVR 组 5 年暴露调整后的 SVD 发生率（每 100 患者年）显著更高（1.61 ± 0.24%比 0.63 ± 0.16%），SVD 相关 BVF（0.58 ± 0.14%比 0.12 ± 0.07%）和全因（结构性或非结构性）BVF（0.81 ± 0.16%比 0.27 ± 0.10%）（所有 p 值均≤0.01）。SAPIEN 3 TAVR 的 5 年 SVD 发生率（0.68 ± 0.18%比 0.60 ± 0.17%；p = 0.71）、SVD 相关 BVF（0.29 ± 0.12%比 0.14 ± 0.08%；p = 0.25）和全因 BVF（0.60 ± 0.15%比 0.32 ± 0.11%；p = 0.32）与匹配的 SAVR 队列无显著差异。SAPIEN 3 TAVR 与匹配队列相比，SVD 和 SVD 相关 BVF 的 5 年发生率显著降低。
结论
与 SAVR 相比，第二代 SAPIEN XT 球囊扩张瓣膜的 5 年 SVD 发生率更高，而第三代 SAPIEN 3 的 SVD 发生率与 SAVR 无差异。（PARTNER II 试验：放置主动脉瓣经导管瓣膜- PII A [PARTNERII A]；NCT01314313；PARTNER II 试验：放置主动脉瓣经导管瓣膜 II - PARTNER II - PARTNERII - S3 中间[PARTNERII S3i]；NCT03222128）。
Zotero 插件