From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.
N Engl J Med. 2020 Jan 9;382(2):111-119. doi: 10.1056/NEJMoa1912846. Epub 2019 Nov 16.
The timing and indications for surgical intervention in asymptomatic patients with severe aortic stenosis remain controversial.
In a multicenter trial, we randomly assigned 145 asymptomatic patients with very severe aortic stenosis (defined as an aortic-valve area of ≤0.75 cm with either an aortic jet velocity of ≥4.5 m per second or a mean transaortic gradient of ≥50 mm Hg) to early surgery or to conservative care according to the recommendations of current guidelines. The primary end point was a composite of death during or within 30 days after surgery (often called operative mortality) or death from cardiovascular causes during the entire follow-up period. The major secondary end point was death from any cause during follow-up.
In the early-surgery group, 69 of 73 patients (95%) underwent surgery within 2 months after randomization, and there was no operative mortality. In an intention-to-treat analysis, a primary end-point event occurred in 1 patient in the early-surgery group (1%) and in 11 of 72 patients in the conservative-care group (15%) (hazard ratio, 0.09; 95% confidence interval [CI], 0.01 to 0.67; P = 0.003). Death from any cause occurred in 5 patients in the early-surgery group (7%) and in 15 patients in the conservative-care group (21%) (hazard ratio, 0.33; 95% CI, 0.12 to 0.90). In the conservative-care group, the cumulative incidence of sudden death was 4% at 4 years and 14% at 8 years.
Among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during the follow-up period was significantly lower among those who underwent early aortic-valve replacement surgery than among those who received conservative care. (Funded by the Korean Institute of Medicine; RECOVERY ClinicalTrials.gov number, NCT01161732.).
对于无症状的重度主动脉瓣狭窄患者，手术干预的时机和适应证仍存在争议。
在一项多中心试验中，我们将 145 例无症状的重度主动脉瓣狭窄患者（定义为主动脉瓣口面积≤0.75cm，或主动脉瓣口流速≥4.5m/s，或平均跨瓣压差≥50mmHg）随机分为早期手术组和保守治疗组，分组依据为现行指南的推荐意见。主要终点是手术期间或术后 30 天内（通常称为手术死亡率）的死亡复合终点，或整个随访期间心血管原因导致的死亡。主要次要终点是随访期间的任何原因导致的死亡。
在早期手术组，73 例患者中有 69 例（95%）在随机分组后 2 个月内接受了手术，且无手术死亡率。意向治疗分析显示，早期手术组有 1 例（1%）患者发生主要终点事件，而保守治疗组有 11 例（15%）患者发生（风险比，0.09；95%置信区间[CI]，0.01 至 0.67；P=0.003）。早期手术组有 5 例（7%）患者和保守治疗组有 15 例（21%）患者（风险比，0.33；95%CI，0.12 至 0.90）死于任何原因。在保守治疗组中，4 年时和 8 年时的猝死累积发生率分别为 4%和 14%。
在无症状的重度主动脉瓣狭窄患者中，与接受保守治疗的患者相比，早期行主动脉瓣置换术的患者在随访期间手术死亡率或心血管原因死亡率的复合发生率显著降低。（由韩国医学研究院资助；RECOVERY ClinicalTrials.gov 注册号：NCT01161732。）
