Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery.
Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery.
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DOI：
10.1056/nejmoa1008232
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发表时间：
2010-10-21
影响因子：
158.5
通讯作者：
Pocock, Stuart
中科院分区：
文献类型：
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作者：
Leon, Martin B.;Smith, Craig R.;Pocock, Stuart
背景：许多患有严重主动脉瓣狭窄和并存疾病的患者不适合手术置换主动脉瓣。最近，经导管主动脉瓣植入术（TAVI）已被建议作为一种微创治疗的高风险患者主动脉瓣狭窄，方法：我们随机分配严重的主动脉瓣狭窄，其中外科医生认为不适合手术的候选人，标准治疗（包括球囊主动脉瓣成形术）或经股动脉经导管植入球囊扩张牛心包瓣膜。主要终点是任何原因的死亡率。结果：共358例主动脉瓣狭窄患者谁不被认为是合适的手术候选人进行随机化在21个中心（17个在美国）。1年时，TAVI组全因死亡率（Kaplan-Meier分析）为30.7%，而标准治疗组为50.7%（TAVI组风险比为0.55; 95%置信区间[CI]为0.40 - 0.74; P
Background: Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.Methods: We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.Results: A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan-Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P