Aortic valve replacement vs. conservative treatment in asymptomatic severe aortic stenosis: long-term follow-up of the AVATAR trial.

IF 37.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal Pub Date : 2024-11-08 DOI:10.1093/eurheartj/ehae585

Marko Banovic, Svetozar Putnik, Bruno R Da Costa, Martin Penicka, Marek A Deja, Martin Kotrc, Radka Kockova, Sigita Glaveckaite, Hrvoje Gasparovic, Nikola Pavlovic, Lazar Velicki, Stefano Salizzoni, Wojtek Wojakowski, Guy Van Camp, Sinisa Gradinac, Michael Laufer, Sara Tomovic, Ivan Busic, Milica Bojanic, Arsen Ristic, Andrea Klasnja, Milos Matkovic, Nikola Boskovic, Katarina Zivic, Miodrag Jovanovic, Serge D Nikolic, Bernard Iung, Jozef Bartunek

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引用次数: 0

Abstract

Background and aims: The question of when and how to treat truly asymptomatic patients with severe aortic stenosis (AS) and normal left ventricular (LV) systolic function is still subject to debate and ongoing research. Here, the results of extended follow-up of the AVATAR trial are reported (NCT02436655, ClinicalTrials.gov).

Methods: The AVATAR trial randomly assigned patients with severe, asymptomatic AS and LV ejection fraction ≥ 50% to undergo either early surgical aortic valve replacement (AVR) or conservative treatment with watchful waiting strategy. All patients had negative exercise stress testing. The primary hypothesis was that early AVR will reduce a primary composite endpoint comprising all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure (HF), as compared with conservative treatment strategy.

Results: A total of 157 low-risk patients (mean age 67 years, 57% men, mean Society of Thoracic Surgeons score 1.7%) were randomly allocated to either the early AVR group (n = 78) or the conservative treatment group (n = 79). In an intention-to-treat analysis, after a median follow-up of 63 months, the primary composite endpoint outcome event occurred in 18/78 patients (23.1%) in the early surgery group and in 37/79 patients (46.8%) in the conservative treatment group [hazard ratio (HR) early surgery vs. conservative treatment 0.42; 95% confidence interval (CI) 0.24-0.73, P = .002]. The Kaplan-Meier estimates for individual endpoints of all-cause death and HF hospitalization were significantly lower in the early surgery compared with the conservative group (HR 0.44; 95% CI 0.23-0.85, P = .012, for all-cause death and HR 0.21; 95% CI 0.06-0.73, P = .007, for HF hospitalizations).

Conclusions: The extended follow-up of the AVATAR trial demonstrates better clinical outcomes with early surgical AVR in truly asymptomatic patients with severe AS and normal LV ejection fraction compared with patients treated with conservative management on watchful waiting.

查看原文本刊更多论文

无症状重度主动脉瓣狭窄的主动脉瓣置换术与保守治疗：AVATAR 试验的长期随访。

背景和目的：何时以及如何治疗真正无症状的重度主动脉瓣狭窄（AS）且左室（LV）收缩功能正常的患者，这一问题仍在争论和研究中。本文报告了 AVATAR 试验（NCT02436655，clinical trials.gov）的延长随访结果：AVATAR试验随机分配无症状、左心室射血分数≥50%的重度AS患者接受早期主动脉瓣置换术（AVR）或保守治疗和观察等待策略。所有患者的运动负荷试验结果均为阴性。主要假设是，与保守治疗策略相比，早期主动脉瓣置换术将降低主要复合终点（包括全因死亡、急性心肌梗死、中风或因心力衰竭（HF）意外住院）：共有 157 名低风险患者（平均年龄 67 岁，57% 为男性，胸外科医师协会平均评分 1.7%）被随机分配到早期 AVR 组（78 人）或保守治疗组（79 人）。在意向治疗分析中，中位随访 63 个月后，主要复合终点结局事件发生率为：早期手术组 18/78 例患者（23.1%），保守治疗组 37/79 例患者（46.8%）（危险比 [HR] 早期手术 vs. 保守治疗 0.42；95% 置信区间 [CI] 0.24-0.73，P=0.002）。早期手术组与保守治疗组相比，全因死亡和心房颤动住院等个别终点的卡普兰-梅耶估计值显著降低（全因死亡的HR为0.44；95% CI为0.23-0.85，P=0.012；心房颤动住院的HR为0.21；95% CI为0.06-0.73，P=0.007）：AVATAR试验的长期随访结果表明，与保守治疗和观察等待相比，对真正无症状的重度AS患者和左心室射血分数正常的患者进行早期手术AVR能获得更好的临床疗效：NCT02436655（ClinicalTrials.gov）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Heart Journal 医学-心血管系统

CiteScore

39.30

自引率

6.90%

发文量

3942

审稿时长

1 months

期刊介绍： The European Heart Journal is a renowned international journal that focuses on cardiovascular medicine. It is published weekly and is the official journal of the European Society of Cardiology. This peer-reviewed journal is committed to publishing high-quality clinical and scientific material pertaining to all aspects of cardiovascular medicine. It covers a diverse range of topics including research findings, technical evaluations, and reviews. Moreover, the journal serves as a platform for the exchange of information and discussions on various aspects of cardiovascular medicine, including educational matters. In addition to original papers on cardiovascular medicine and surgery, the European Heart Journal also presents reviews, clinical perspectives, ESC Guidelines, and editorial articles that highlight recent advancements in cardiology. Additionally, the journal actively encourages readers to share their thoughts and opinions through correspondence.