Rigshospitalet, Copenhagen University Hospital, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark.
Department of Cardiology and Cardiothoracic Surgery, Turku University Hospital, Turku, Finland.
Eur Heart J. 2024 Oct 5;45(37):3804-3814. doi: 10.1093/eurheartj/ehae331.
Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤75 years of age, including both tricuspid and bicuspid AS.
The Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months.
A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% confidence interval (CI), -2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7-2.9; P = .3]. Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5-2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8-18.5) treated with TAVI or surgery, respectively (P for interaction = .1).
Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).
ClinicalTrials.gov NCT02825134.
经导管主动脉瓣置换术（TAVI）已成为治疗高龄、严重症状性主动脉瓣狭窄（AS）患者的首选方法。本研究旨在比较 TAVI 与手术在低危患者（年龄≤75 岁）中的疗效，包括三尖瓣和二叶式主动脉瓣狭窄患者。
北欧经导管主动脉瓣介入治疗（NOTION）-2 试验纳入了年龄≤75 岁、严重症状性 AS 的低危患者，以 1:1 比例随机分组，分别接受 TAVI 或手术治疗。主要终点是 12 个月时全因死亡率、卒中和再住院（与手术过程、瓣膜或心力衰竭相关）的复合终点。
共纳入 370 例患者，平均年龄 71.1 岁，胸外科医生协会风险评分中位数为 1.1%。共 100 例患者为二叶式主动脉瓣狭窄。TAVI 组和手术组的 1 年主要终点发生率分别为 10.2%和 7.1%[绝对风险差 3.1%；95%置信区间（CI）：-2.7%至 8.8%；风险比（HR）1.4；95%CI：0.7-2.9；P=.3]。与手术组相比，TAVI 组的大出血和新发心房颤动风险较低，而非致残性卒中和永久性起搏器植入以及中重度瓣周漏的风险较高。三尖瓣 AS 患者的主要复合终点发生率为 8.7%和 8.3%（HR 1.0；95%CI：0.5-2.3），二叶式主动脉瓣狭窄患者为 14.3%和 3.9%（HR 3.8；95%CI：0.8-18.5）（P 交互=.1）。
在年龄≤75 岁、严重症状性 AS 的低危患者中，TAVI 与手术治疗 1 年时的死亡、卒中和再住院复合终点发生率相似。TAVI 在年轻二叶式主动脉瓣狭窄患者中的应用结果需要谨慎，并需要进一步研究。（NOTION-2，ClinicalTrials.gov，NCT02825134）。
ClinicalTrials.gov NCT02825134。
