Columbia University Irving Medical Center and NewYork-Presbyterian Hospital, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.
Columbia University Irving Medical Center and NewYork-Presbyterian Hospital, New York, New York, USA.
J Am Coll Cardiol. 2023 Jul 11;82(2):109-123. doi: 10.1016/j.jacc.2023.04.049.
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).
先前的研究表明，在 5 年时，对于有症状的严重主动脉瓣狭窄的中危患者，第一代球囊扩张式经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术（SAVR）相比，在死亡和致残性卒中方面非劣效。然而，具有现代 SAPIEN 3（S3）生物瓣的长期数据有限。
本研究旨在比较中危患者接受 S3 TAVR 与 SAVR 的 5 年风险调整后结局。
在 PARTNER 2（经导管主动脉瓣置换术的放置）S3 单臂研究中，对接受 S3 TAVR 的中危患者进行倾向评分匹配，以考虑到基线差异，并在 PARTNER 2A 随机临床试验中对 SAVR 进行倾向评分匹配。主要复合终点包括 5 年全因死亡和致残性卒中。
共研究了 783 对匹配的中危严重主动脉瓣狭窄患者。5 年时，S3 TAVR 与 SAVR 之间在主要终点方面无差异（40.2%比 42.7%；HR：0.87；95%CI：0.74-1.03；P=0.10）。S3 TAVR 后轻度或更严重瓣周漏的发生率更高。结构性瓣膜退化相关的 2 级和 3 级血流动力学瓣膜退化或生物瓣失效无差异。
在这项对中危患者的倾向评分匹配分析中，S3 TAVR 和 SAVR 的 5 年死亡率和致残性卒中发生率相似。结构性瓣膜退化相关的血流动力学瓣膜退化的发生率相似，但 S3 TAVR 后瓣周漏更常见。需要更长时间的随访来进一步评估晚期不良临床事件和生物瓣耐久性的差异。（PII S3i[PARTNER II 试验：经导管主动脉瓣置换术 II - S3 中危]，NCT03222128；PII A[PARTNER II 试验：经导管主动脉瓣置换术 II - XT 中危和高危]，NCT01314313）。
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