3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
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DOI：
10.1016/j.jacc.2023.02.017
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发表时间：
2023-04-24
影响因子：
24
通讯作者：
Low Risk Trial Investigators
中科院分区：
文献类型：
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作者：
Forrest, John K.;Deeb, G. Michael;Low Risk Trial Investigators
背景：在2年以上的时间点，比较低手术风险患者经导管主动脉瓣置换术（TAVR）与手术结局的随机数据有限。这对努力教育患者作为共同决策过程的一部分的医生来说是一个未知数。作者评价了Evolut低风险试验的3年临床和超声心动图结局。方法将低风险患者随机分配至TAVR（带自膨式瓣环上瓣膜）或手术组。在3年时评估了全因死亡或致残性卒中的主要终点和几个次要终点。结果有1，414例尝试施行了TAVR（730例TAVR; 684例手术）。患者平均年龄为74岁，35%为女性。3年时，7.4%的TAVR患者和10.4%的手术患者发生了主要终点（HR：0.70; 95% CI：0.49-1.00; P = 0.051）。治疗组间全因死亡率或致残性卒中的差异随时间推移保持大致一致：第1年为-1.8%;第2年为-2.0%;第3年为-2.9%。手术组的轻度瓣周返流（20.3% TAVR vs 2.5%手术）和起搏器置入（23.2% TAVR vs 9.1%手术; P < 0.001）发生率较低。两组中度或重度瓣周返流的发生率分别为
BACKGROUND Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time:-1.8% at year 1;-2.0% at year 2; and-2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were