E. Galli , A. Coisne , F. Le Ven , C. Sportuch , O. Lairez , A. Bernard , E. Oger , E. Le Pabic , E. Donal
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The follow-up lasted 14<!--> <!-->±<!--> <span>7 months. The study was interrupted early because of the low inclusion rate during the COVID-2019 pandemic. The AS severity was confirmed by a multimodality approach including dobutamine<span> stress echocardiography and/or aortic calcium score. The primary end-point (overall death and/or hospitalisation for heart failure) occurred in 13 (25%) patients.</span></span></p></div><div><h3>Results</h3><p>Patients undergoing AVR showed a similar recurrence of events (overall death, heart failure hospitalisation) compared to patients receiving OMT (5 vs. 8 events). Patients receiving OMT did not experience worse survival compared to patients receiving AVR (HR 1.57, 95% CI: 0.51–4.83, <em>P</em> <!-->=<!--> <!-->0.4275). Kaplan-Meier curves showed similar event-free survival (logrank <em>P</em> <!-->=<!--> <!-->0.4236) among the 2 groups (<span>Fig. 1</span>).</p></div><div><h3>Conclusion</h3><p>In the randomized ROTAS trial, AVR is not associated with a better prognosis in symptomatic patients with LG severe AS and preserved LVEF.</p><p>.</p></div>","PeriodicalId":8140,"journal":{"name":"Archives of Cardiovascular Diseases Supplements","volume":"15 3","pages":"Pages 245-246"},"PeriodicalIF":18.0000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized study for the optimal treatment of symptomatic patients with low gradient severe aortic valve stenosis and preserved left ventricular ejection fraction (ROTAS trial)\",\"authors\":\"E. Galli , A. Coisne , F. Le Ven , C. Sportuch , O. Lairez , A. Bernard , E. Oger , E. Le Pabic , E. 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引用次数: 0
摘要
背景:低梯度(LG)严重主动脉瓣狭窄(AS)和左室射血分数(LVEF)保留的症状患者的最佳治疗方法尚未在随机对照试验中确定。ROTAS试验旨在评估有症状的LG严重AS并保留LVEF患者主动脉瓣置换术(AVR)与优化药物治疗(OMT)的优越性。方法52例患者(年龄79±7岁;男性46%，平均主动脉梯度:31±5 mmHg;主动脉面积:0.8±0.1 cm2)，按1:1随机分为AVR组和OMT组。随访14±7个月。由于2019冠状病毒病大流行期间纳入率低，研究提前中断。通过多模态方法确认AS的严重程度，包括多巴酚丁胺应激超声心动图和/或主动脉钙评分。主要终点(总死亡和/或因心力衰竭住院)发生在13例(25%)患者中。结果与接受OMT的患者相比，接受AVR的患者显示出相似的事件复发(总死亡、心力衰竭住院)(5 vs 8)。与接受AVR的患者相比，接受OMT的患者的生存率并不差(HR 1.57, 95% CI: 0.51-4.83, P = 0.4275)。Kaplan-Meier曲线显示两组患者无事件生存率相似(logrank P = 0.4236)(图1)。结论在随机化的ROTAS试验中，有症状的LG严重AS患者的AVR与更好的预后无关。
Randomized study for the optimal treatment of symptomatic patients with low gradient severe aortic valve stenosis and preserved left ventricular ejection fraction (ROTAS trial)
Introduction
Background: the best management of symptomatic patients with low gradient (LG) severe aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF) has not been established in randomized controlled trials. The ROTAS trial aimed to assess the superiority of aortic valve replacement (AVR) versus optimized medical therapy (OMT) in symptomatic patients with LG severe AS and preserved LVEF.
Method
Fifty-two patients (age 79 ± 7 years; males 46%, mean aortic gradient: 31 ± 5 mmHg; aortic surface: 0.8 ± 0.1 cm2) who were randomized 1:1 to AVR or OMT. The follow-up lasted 14 ± 7 months. The study was interrupted early because of the low inclusion rate during the COVID-2019 pandemic. The AS severity was confirmed by a multimodality approach including dobutamine stress echocardiography and/or aortic calcium score. The primary end-point (overall death and/or hospitalisation for heart failure) occurred in 13 (25%) patients.
Results
Patients undergoing AVR showed a similar recurrence of events (overall death, heart failure hospitalisation) compared to patients receiving OMT (5 vs. 8 events). Patients receiving OMT did not experience worse survival compared to patients receiving AVR (HR 1.57, 95% CI: 0.51–4.83, P = 0.4275). Kaplan-Meier curves showed similar event-free survival (logrank P = 0.4236) among the 2 groups (Fig. 1).
Conclusion
In the randomized ROTAS trial, AVR is not associated with a better prognosis in symptomatic patients with LG severe AS and preserved LVEF.
期刊介绍：
Archives of Cardiovascular Diseases Supplements is the official journal of the French Society of Cardiology. The journal publishes original peer-reviewed clinical and research articles, epidemiological studies, new methodological clinical approaches, review articles, editorials, and Images in cardiovascular medicine. The topics covered include coronary artery and valve diseases, interventional and pediatric cardiology, cardiovascular surgery, cardiomyopathy and heart failure, arrhythmias and stimulation, cardiovascular imaging, vascular medicine and hypertension, epidemiology and risk factors, and large multicenter studies. Additionally, Archives of Cardiovascular Diseases also publishes abstracts of papers presented at the annual sessions of the Journées Européennes de la Société Française de Cardiologie and the guidelines edited by the French Society of Cardiology.
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