重度主动脉瓣狭窄患者随机接受经导管与外科主动脉瓣置换术的两年结果：全人群北欧主动脉瓣干预随机临床试验
Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial.
作者信息
Søndergaard Lars, Steinbrüchel Daniel Andreas, Ihlemann Nikolaj, Nissen Henrik, Kjeldsen Bo Juel, Petursson Petur, Ngo Anh Thuc, Olsen Niels Thue, Chang Yanping, Franzen Olaf Walter, Engstrøm Thomas, Clemmensen Peter, Olsen Peter Skov, Thyregod Hans Gustav Hørsted
机构信息
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
出版信息
Circ Cardiovasc Interv. 2016 Jun;9(6). doi: 10.1161/CIRCINTERVENTIONS.115.003665.
BACKGROUND
The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial.
METHODS AND RESULTS
Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59).
CONCLUSIONS
Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.
背景
北欧主动脉瓣干预（NOTION）试验是首个将所有重度原发性主动脉瓣狭窄患者随机分为接受CoreValve自膨胀生物假体经导管主动脉瓣置换术（TAVR）或外科主动脉瓣置换术（SAVR）的试验，纳入的低风险患者群体比以往试验更多。本文报告NOTION试验的2年临床和超声心动图结果。
方法与结果
来自丹麦和瑞典3个中心的280例患者被随机分为TAVR组（n = 145）或SAVR组（n = 135），计划随访5年。TAVR组和SAVR组2年全因死亡率无差异（分别为8.0%和9.8%；P = 0.54），心血管死亡率也无差异（6.5%对9.1%；P = 0.40）。全因死亡率、卒中或心肌梗死的复合结局也相似（15.8%对18.8%，P = 0.43）。两种手术均改善了前向血流动力学，TAVR术后有效瓣口面积的改善明显大于SAVR（3个月时有效瓣口面积分别为1.7和1.4 cm²）。TAVR和SAVR术后平均跨瓣压差相似。根据胸外科医师协会预测死亡率（STS - PROM）（<4%对≥4%）对患者进行分类时，TAVR组和SAVR组在低风险（14.7%，95%置信区间8.3 - 21.2对16.8%；95%置信区间9.7 - 23.8；P = 0.58）或中风险患者（21.1%对27.1%；P = 0.59）的复合结局方面无统计学显著差异。
结论
NOTION试验的2年结果表明TAVR在低风险患者中持续具有安全性和有效性。需要长期数据来验证该手术在该患者群体中的耐久性。
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