Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients
Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients
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DOI：
10.1056/nejmoa1814052
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发表时间：
2019-05-02
影响因子：
158.5
通讯作者：
Smith, C. R.
中科院分区：
文献类型：
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作者：
Mack, M. J.;Leon, M. B.;Smith, C. R.
背景：在手术死亡风险中等或较高的主动脉瓣狭窄患者中，经导管主动脉瓣置换术（TAVR）和外科主动脉瓣置换术的主要结局相似。关于两种手术在低风险患者中的比较证据不足。方法：我们随机分配严重主动脉瓣狭窄且手术风险低的患者接受经股动脉瓣膜置换术或手术治疗。主要终点是死亡、中风或1年后再次住院的综合指标。在接受治疗的人群中进行非劣效性检验（预先规定的误差为6个百分点）和优越性检验。结果在71个中心，1000名患者接受了随机分组。患者的平均年龄为73岁，胸外科学会的平均风险评分为1.9%（评分范围从0到100%，评分越高表明手术后30天内死亡的风险越大）。TAVR组1年主要复合终点率的Kaplan-Meier估计值明显低于手术组(8.5% vs. 15.1%；绝对差值为-6.6个百分点；95%可信区间[CI]， -10.8 ~ -2.5
BACKGROUNDAmong patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.METHODSWe randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.RESULTSAt 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P