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[NEJM在线发表]:无症状主动脉瓣狭窄患者早期手术与保守治疗
2019年12月10日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE FREE PREVIEW

Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis

Duk-Hyun Kang, Sung-Ji Park, Seung-Ah Lee, et al

N Engl J Med November 16, 2019
DOI: 10.1056/NEJMoa1912846

BACKGROUND 背景

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

无症状的严重主动脉瓣狭窄患者手术干预的时机及适应症存在争议。

METHODS 方法

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.

在这项多中心研究中,我们将145名无症状的严重主动脉瓣狭窄(定义为主动脉瓣环面积≤ 0.75 cm2 伴主动脉流速 ≥ 4.5 m/sec 或平均跨瓣压差 ≥ 50 mm Hg)患者随机分为早期手术或保守治疗组(根据当前指南的推荐)。主要研究重点为复合指标,包括手术后30天内死亡(常称为手术病死率)或在整个随访期间因心血管原因死亡。主要次要终点为随访期间任何原因导致的死亡。

RESULTS 结果

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.

早期手术组73名患者中69名(95%)在随机分组后2个月内接受了手术治疗,无手术死亡发生。根据意向治疗分析,早期手术组中1名患者(1%)及保守治疗组72名患者中11名患者(15%)发生主要终点事件 (风险比, 0.09; 95% 可信区间 [CI], 0.01 to 0.67; P=0.003)。早期手术组与保守治疗组分别有5名 (7%) 和15名 (21%) 患者发生任何原因导致的死亡 (风险比, 0.33; 95% CI, 0.12 to 0.90)。在保守治疗组,猝死的累计发生率在4年时为4%,8年时为14%。

CONCLUSIONS 结论

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.

对于无症状的极为严重的主动脉瓣狭窄患者,与接受保守治疗相比,早期主动脉瓣置换手术能够显著降低手术死亡或随访期间心血管原因导致的死亡。

(Funded by the Korean Institute of Medicine; RECOVERY ClinicalTrials.gov number, NCT01161732. opens in new tab.)

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