经导管主动脉瓣置换术，使用自扩张假体。
Transcatheter aortic-valve replacement with a self-expanding prosthesis.
机构信息
From Mount Sinai Medical Center, New York (D.H.A.), and St. Francis Hospital, Roslyn (N.R., G.P.) - both in New York; Beth Israel Deaconess Medical Center, Boston (J.J.P.); Houston Methodist DeBakey Heart and Vascular Center (M.J.R., N.S.K.), and Texas Heart Institute at St. Luke's Medical Center (J.S.C.) - both in Houston; Riverside Methodist Hospital, Columbus, OH (S.J.Y.); University of Michigan Medical Center, Ann Arbor (G.M.D., S. Chetcuti), and Spectrum Health Hospitals, Grand Rapids (J.H., W.M.) - both in Michigan; University of Pittsburgh Medical Center, Pittsburgh (T.G.G.); Palo Alto Veterans Affairs Medical Center, Palo Alto, CA (M.B.); St. Vincent Medical Center, Indianapolis (J.H.); University of Kansas Hospital, Kansas City (G.Z., P.T.); Duke University Medical Center, Durham, NC (G.C.H., J.K.H.); Johns Hopkins Hospital, Baltimore (J.C.); Pinnacle Health, Harrisburg, PA (B.M., M.M.); and Medtronic, Minneapolis (S. Chenoweth), and Mayo Clinical Foundation, Rochester (J.K.O.) - both in Minnesota.
出版信息
N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
BACKGROUND
We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery.
METHODS
We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing.
RESULTS
A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke.
CONCLUSIONS
In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).
背景
我们比较了经导管主动脉瓣置换术（TAVR），使用自膨式经导管主动脉瓣生物瓣，与手术主动脉瓣置换术在严重主动脉瓣狭窄和手术期间死亡风险增加的患者。
方法
我们招募了每个研究中心心脏团队确定手术风险增加的严重主动脉瓣狭窄患者。风险评估包括胸外科医生协会预测死亡率估计和其他关键风险因素的考虑。符合条件的患者以 1:1 的比例随机分配接受自膨式经导管瓣膜的 TAVR（TAVR 组）或手术主动脉瓣置换术（手术组）。主要终点是 1 年时任何原因导致的死亡率，使用非劣效性和优效性检验进行评估。
结果
共有 795 名患者在 45 个美国中心进行了随机分组。在实际治疗分析中，TAVR 组 1 年时任何原因导致的死亡率明显低于手术组（14.2%对 19.1%），风险降低绝对值为 4.9 个百分点（95%置信区间上限，-0.4；非劣效性 P<0.001；优效性 P=0.04）。意向治疗分析结果相似。在分层检验程序中，TAVR 在瓣膜狭窄、功能状态和生活质量的超声心动图指标方面不劣于手术。探索性分析表明，主要不良心血管和脑血管事件发生率降低，中风风险无增加。
结论
在手术风险增加的严重主动脉瓣狭窄患者中，与手术主动脉瓣置换术相比，自膨式经导管主动脉瓣生物瓣 TAVR 可显著提高 1 年生存率。（由美敦力公司资助；美国核心瓣膜高危研究临床试验.gov 编号，NCT01240902）。
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