Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen 2100, Denmark.
Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen 2100, Denmark.
Eur Heart J. 2021 Aug 7;42(30):2912-2919. doi: 10.1093/eurheartj/ehab375.
AIMS: The aims of the study were to compare clinical outcomes and valve durability after 8 years of follow-up in patients with symptomatic severe aortic valve stenosis at low surgical risk treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). METHODS AND RESULTS: In the NOTION trial, patients with symptomatic severe aortic valve stenosis were randomized to TAVI or SAVR. Clinical status, echocardiography, structural valve deterioration, and failure were assessed using standardized definitions. In total, 280 patients were randomized to TAVI (n = 145) or SAVR (n = 135). Baseline characteristics were similar, including mean age of 79.1 ± 4.8 years and a mean STS score of 3.0 ± 1.7%. At 8-year follow-up, the estimated risk of the composite outcome of all-cause mortality, stroke, or myocardial infarction was 54.5% after TAVI and 54.8% after SAVR (P = 0.94). The estimated risks for all-cause mortality (51.8% vs. 52.6%; P = 0.90), stroke (8.3% vs. 9.1%; P = 0.90), or myocardial infarction (6.2% vs. 3.8%; P = 0.33) were similar after TAVI and SAVR. The risk of structural valve deterioration was lower after TAVI than after SAVR (13.9% vs. 28.3%; P = 0.0017), whereas the risk of bioprosthetic valve failure was similar (8.7% vs. 10.5%; P = 0.61). CONCLUSIONS: In patients with severe aortic valve stenosis at low surgical risk randomized to TAVI or SAVR, there were no significant differences in the risk for all-cause mortality, stroke, or myocardial infarction, as well as the risk of bioprosthetic valve failure after 8 years of follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.
目的:本研究旨在比较低手术风险的有症状重度主动脉瓣狭窄患者接受经导管主动脉瓣植入术(TAVI)或外科主动脉瓣置换术(SAVR)治疗 8 年后的临床结局和瓣膜耐久性。
方法和结果:在 NOTION 试验中,有症状的重度主动脉瓣狭窄患者被随机分为 TAVI 或 SAVR 组。采用标准化定义评估临床状况、超声心动图、结构性瓣膜恶化和瓣膜失效。共 280 例患者被随机分为 TAVI 组(n=145)或 SAVR 组(n=135)。基线特征相似,包括平均年龄 79.1±4.8 岁和平均 STS 评分 3.0±1.7%。8 年随访时,TAVI 组和 SAVR 组全因死亡率、卒中和心肌梗死的复合终点的估计风险分别为 54.5%和 54.8%(P=0.94)。全因死亡率(51.8% vs. 52.6%;P=0.90)、卒(8.3% vs. 9.1%;P=0.90)或心肌梗死(6.2% vs. 3.8%;P=0.33)的风险在 TAVI 和 SAVR 后相似。TAVI 组结构性瓣膜恶化的风险低于 SAVR 组(13.9% vs. 28.3%;P=0.0017),而生物瓣失效的风险相似(8.7% vs. 10.5%;P=0.61)。
结论:在低手术风险的有症状重度主动脉瓣狭窄患者中,随机接受 TAVI 或 SAVR 治疗,8 年随访后全因死亡率、卒中和心肌梗死的风险以及生物瓣失效的风险无显著差异。
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