Background and Aims Transcatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years. Methods The NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD. Results Baseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7–1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04–0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4–1.5; P = .4). Conclusions In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.

中文翻译：

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经导管或外科主动脉瓣植入：NOTION 试验的 10 年结果

背景和目标 经导管主动脉瓣植入术 (TAVI) 已成为各种手术风险的严重主动脉瓣狭窄患者的可行治疗选择。 Nordic 主动脉瓣介入 (NOTION) 试验是第一个将 TAVI 或主动脉瓣置换术 (SAVR) 手术风险较低的患者随机分组的试验。本研究的目的是报告 10 年后的临床和生物假体结果。方法 NOTION 试验将 280 名患者随机分配至使用自膨胀式 CoreValve (Medtronic Inc.) 生物假体的 TAVI (n = 145) 或使用生物假体的 SAVR (n = 135)。主要复合结局是全因死亡、中风或心肌梗死的风险。根据瓣膜学术研究联盟-3 标准，生物瓣膜功能障碍 (BVD) 被分类为结构性瓣膜退化 (SVD)、非结构性瓣膜功能障碍 (NSVD)、临床瓣膜血栓或心内膜炎。严重 SVD 定义为 (i) 经假体梯度为 30 mmHg 或更高，经假体梯度增加为 20 mmHg 或更高，或 (ii) 严重的新假体内反流。生物瓣膜衰竭（BVF）被定义为瓣膜相关原因导致的死亡率或诊断为 BVD、主动脉瓣再介入或严重 SVD 后不明原因死亡的复合率。结果 TAVI 和 SAVR 的基线特征相似：年龄 79.2 ± 4.9 岁和 79.0 ± 4.7 岁 (P = .7)，男性分别为 52.6% 和 53.8% (P = .8)，胸外科医师协会评分 < 1。分别为 83.4% 和 80.0% 的 4% (P = .5)。 10 年后，TAVI 后发生全因死亡、卒中或心肌梗塞的复合结局风险为 65.5%，SAVR 后为 65.5% [风险比 (HR) 1.0； 95% 置信区间 (CI) 0.7–1.3； P = .9]，每个个体的结果没有差异。 TAVI 和 SAVR 后，严重 SVD 的发生率分别为 1.5% 和 10.0%（HR 0.2；95% CI 0.04–0.7；P = .02）。 TAVI 和 SAVR 后，严重 NSVD 的累积发生率分别为 20.5% 和 43.0% (P < .001)，心内膜炎的累积发生率分别为 7.2% 和 7.4% (P = 1.0)。没有患者出现临床瓣膜血栓。 9.7% 的 TAVI 患者和 13.8% 的 SAVR 患者出现生物瓣膜衰竭（HR 0.7；95% CI 0.4–1.5；P = .4）。结论 在随机接受 TAVI 或 SAVR 的手术风险较低的严重 AS 患者中，治疗 10 年后主要临床结果的风险没有差异。与 SAVR 相比，TAVR 后发生严重生物假体 SVD 的风险较低，而 BVF 的风险相似。