韩国蔚山大学医学院Duk-Hyun Kang联合成均馆大学医学院Seung-Woo Park研究团队，比较了无症状主动脉瓣狭窄行早期手术或保守治疗的效果。这一研究成果2019年11月16日发表在《新英格兰医学杂志》上。

目前，无症状严重主动脉瓣狭窄患者的手术时机和适应症仍存在争议。

在这项多中心试验中，根据当前指南建议，研究组招募了145名无症状的主动脉瓣狭窄患者，即主动脉瓣面积≤0.75 cm²，主动脉喷射速度≥4.5 m/s，或平均主动脉瓣压力梯度≥50 mmHg。将患者随机分组，其中73例接受早期手术，72例进行保守治疗。

早期手术组中有69例在分组后2月内施行手术，术后30天内无1例死亡。在意向治疗分析中，早期手术组中有1例（1%）患者发生心血管死亡，保守治疗组中有11例（15%），危险比为0.09。早期手术组中有5例（7%）患者全因死亡，保守治疗组中有15例（21%），危险比为0.33。保守治疗组中，4年和8年时的累积猝死发生率分别为4%和14%。

总之，对于无症状的严重主动脉瓣狭窄患者，接受早期主动脉瓣置换手术与保守治疗相比，可显著降低心血管原因的死亡率。

附：英文原文

Title: Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis

Author: Duk-Hyun Kang, M.D., Ph.D.,, Sung-Ji Park, M.D., Ph.D.,, Seung-Ah Lee, M.D.,, Sahmin Lee, M.D., Ph.D.,, Dae-Hee Kim, M.D., Ph.D.,, Hyung-Kwan Kim, M.D., Ph.D.,, Sung-Cheol Yun, Ph.D.,, Geu-Ru Hong, M.D., Ph.D.,, Jong-Min Song, M.D., Ph.D.,, Cheol-Hyun Chung, M.D., Ph.D.,, Jae-Kwan Song, M.D., Ph.D.,, Jae-Won Lee, M.D., Ph.D.,, and Seung-Woo Park, M.D., Ph.D.

Issue&Volume: November 16, 2019

Abstract:

Background

The timing and indications for surgical intervention in asymptomatic patients with severe aortic stenosis remain controversial.

Methods

In a multicenter trial, we randomly assigned 145 asymptomatic patients with very severe aortic stenosis (defined as an aortic-valve area of ≤0.75 cm2 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.

Results

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.

Conclusions

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.

DOI: 10.1056/NEJMoa1912846

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1912846