Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients
Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients
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DOI：
10.1056/nejmoa1103510
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发表时间：
2011-06-09
影响因子：
158.5
通讯作者：
Pocock, Stuart J.
中科院分区：
文献类型：
--
作者：
Smith, Craig R.;Leon, Martin B.;Pocock, Stuart J.
背景经导管主动脉瓣置换术已被证明可以降低不适合手术置换的高危主动脉瓣狭窄患者的死亡率。然而，这两个程序还没有进行比较，在一项随机试验中涉及高危患者谁仍然是候选人的外科replacement.MethodsAt 25个centers，我们随机分配699高风险的严重主动脉瓣狭窄患者进行经导管动脉瓣置换术与球囊扩张牛心包瓣膜（无论是经股动脉或经心尖的方法）或手术置换。主要终点是1年时任何原因导致的死亡。主要假设是经导管置换并不劣于手术置换。结果30天时，经导管组全因死亡率为3.4%，手术组全因死亡率为6.5%（P = 0.07），1年时分别为24.2%和26.8%（P = 0.44），经导管组减少2.6个百分点（95%置信区间上限，3.0个百分点;预定义界限，7.5个百分点;非劣效性P = 0.001）。30天时，经导管组和手术组的严重卒中发生率分别为3.8%和2.1%（P = 0.20），1年时分别为5.1%和2.4%（P = 0.07）。术后30天，经导管置换术的主要血管并发症发生率明显更高（11.0% vs. 3.2%，P
BackgroundThe use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.MethodsAt 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.ResultsThe rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P = 0.07) and 24.2% and 26.8%, respectively, at 1 year (P = 0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P = 0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P = 0.20) and 5.1% and 2.4%, respectively, at 1 year (P = 0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P