Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

Philippe Généreux,Allan Schwartz，Martin B Leon, EARLY TAVR Trial Investigators

The New England journal of medicine（2024）

From Gagnon Cardiovascular Institute

Cited 0|Views4

Abstract

BACKGROUND:For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking. METHODS:At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population. RESULTS:A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement. CONCLUSIONS:Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.).

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【要点】：本研究发现，对于无症状的重度主动脉瓣狭窄患者，早期采用经导管主动脉瓣置换（TAVR）的策略相较于临床监测可显著降低死亡、中风或因心血管原因未计划的住院的发生率。

【方法】：在美国和加拿大75个中心，研究者将无症状的重度主动脉瓣狭窄患者以1:1的比例随机分配到早期TAVR组（经股动脉置入球囊扩张瓣膜）和临床监测组，对两组患者进行意向治疗分析。

【实验】：共901例患者参与随机分组，其中455例行TAVR，446例行临床监测。中位随访3.8年后，TAVR组与临床监测组相比，主要终点事件（死亡、中风或因心血管原因未计划的住院）发生率分别为26.8%和45.3%，TAVR组显著低于临床监测组。使用的数据集为临床试验数据，临床试验注册号为NCT03042104。