Elena Galli, Florent Le Ven, Augustin Coisne, Catherine Sportouch, Thierry Le Tourneau, Yoan Lavie-Badie, Anne Bernard, Jean-Christophe Eicher, Julien Dreyfus, Julien Ternacle, Serge Baleynaud, Vincent Auffret, Estelle Le Pabic, Philippe Pibarot, Emmanuel Oger, Erwan Donal
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The Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis (ROTAS) trial aimed to assess the superiority of aortic valve replacement (AVR) versus medical treatment (MT) in this specific group of AS patients.</p><p><strong>Methods: </strong>Patients with symptomatic LG severe AS and preserved LVEF (>50%) underwent dobutamine stress echocardiography and/or CT-aortic calcium score to confirm AS severity and were then randomised 1:1 to AVR or MT. The primary endpoint was a composite of overall death and/or cardiovascular hospitalisation.</p><p><strong>Results: </strong>The ROTAS study was stopped early because of insufficient recruitment. In the end, only 52 patients (age 79±7 years; women 54%; NYHA III-IV 27%; median STS score 3.3%) were included in the study. During follow-up (mean: 14±7 months), the primary endpoint occurred in 12 (23%) patients. Compared with MT, AVR was not associated with a significant prognostic benefit (events: 5/26 (19%) vs 7/26 (27%) (HR 0.76, 95% CI 0.24 to 2.39, p=0.63). During follow-up, 11 (42%) patients in the MT group developed class I criteria for AVR or severe symptoms justifying a cross-over to the AVR group.</p><p><strong>Conclusions: </strong>Because of the small number of included patients and short follow-up the ROTAS trial was underpowered and unable to demonstrate a difference in the study endpoint between treatment arms. In patients in the MT arm, a regular echocardiographic and clinical assessment might be useful to disclose those developing class I indications of AVR or severe AS-related symptoms.</p><p><strong>Trial registration number: </strong>NCT01835028.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":null,"pages":null},"PeriodicalIF":5.1000,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial).\",\"authors\":\"Elena Galli, Florent Le Ven, Augustin Coisne, Catherine Sportouch, Thierry Le Tourneau, Yoan Lavie-Badie, Anne Bernard, Jean-Christophe Eicher, Julien Dreyfus, Julien Ternacle, Serge Baleynaud, Vincent Auffret, Estelle Le Pabic, Philippe Pibarot, Emmanuel Oger, Erwan Donal\",\"doi\":\"10.1136/heartjnl-2024-324224\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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. The Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis (ROTAS) trial aimed to assess the superiority of aortic valve replacement (AVR) versus medical treatment (MT) in this specific group of AS patients.</p><p><strong>Methods: </strong>Patients with symptomatic LG severe AS and preserved LVEF (>50%) underwent dobutamine stress echocardiography and/or CT-aortic calcium score to confirm AS severity and were then randomised 1:1 to AVR or MT. The primary endpoint was a composite of overall death and/or cardiovascular hospitalisation.</p><p><strong>Results: </strong>The ROTAS study was stopped early because of insufficient recruitment. In the end, only 52 patients (age 79±7 years; women 54%; NYHA III-IV 27%; median STS score 3.3%) were included in the study. During follow-up (mean: 14±7 months), the primary endpoint occurred in 12 (23%) patients. Compared with MT, AVR was not associated with a significant prognostic benefit (events: 5/26 (19%) vs 7/26 (27%) (HR 0.76, 95% CI 0.24 to 2.39, p=0.63). During follow-up, 11 (42%) patients in the MT group developed class I criteria for AVR or severe symptoms justifying a cross-over to the AVR group.</p><p><strong>Conclusions: </strong>Because of the small number of included patients and short follow-up the ROTAS trial was underpowered and unable to demonstrate a difference in the study endpoint between treatment arms. In patients in the MT arm, a regular echocardiographic and clinical assessment might be useful to disclose those developing class I indications of AVR or severe AS-related symptoms.</p><p><strong>Trial registration number: </strong>NCT01835028.</p>\",\"PeriodicalId\":12835,\"journal\":{\"name\":\"Heart\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":5.1000,\"publicationDate\":\"2024-09-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Heart\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/heartjnl-2024-324224\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Heart","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/heartjnl-2024-324224","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景:低梯度(LG)重度主动脉瓣狭窄(AS)且左室射血分数(LVEF)保留的无症状患者的最佳治疗方法尚未确定。低梯度重度主动脉瓣狭窄无症状患者最佳治疗随机研究(ROTAS)试验旨在评估主动脉瓣置换术(AVR)与药物治疗(MT)在这一特定主动脉瓣狭窄患者群体中的优越性:有症状的 LG 重度 AS 和 LVEF 保留(>50%)的患者接受多巴酚丁胺应激超声心动图检查和/或 CT 主动脉钙化评分以确认 AS 的严重程度,然后按 1:1 随机分配接受 AVR 或 MT 治疗。主要终点是总死亡和/或心血管住院治疗的综合结果:结果:由于招募人数不足,ROTAS 研究提前结束。最终,只有52名患者(年龄为79±7岁;女性占54%;NYHA III-IV级占27%;STS评分中位数为3.3%)被纳入研究。在随访期间(平均:14±7 个月),12 名患者(23%)出现了主要终点。与 MT 相比,AVR 在预后方面没有明显优势(事件:5/26(19%)vs 5/26(19%)):5/26 (19%) vs 7/26 (27%) (HR 0.76, 95% CI 0.24 to 2.39, p=0.63)。在随访期间,MT 组中有 11 名(42%)患者达到了 AVR 的 I 级标准或出现了严重症状,因此有理由转入 AVR 组:结论:由于纳入的患者人数较少且随访时间较短,ROTAS 试验的能量不足,无法证明治疗组之间的研究终点存在差异。对于MT治疗组的患者,定期进行超声心动图和临床评估可能有助于发现那些出现I级AVR指征或严重AS相关症状的患者:NCT01835028.
Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial).
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. The Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis (ROTAS) trial aimed to assess the superiority of aortic valve replacement (AVR) versus medical treatment (MT) in this specific group of AS patients.
Methods: Patients with symptomatic LG severe AS and preserved LVEF (>50%) underwent dobutamine stress echocardiography and/or CT-aortic calcium score to confirm AS severity and were then randomised 1:1 to AVR or MT. The primary endpoint was a composite of overall death and/or cardiovascular hospitalisation.
Results: The ROTAS study was stopped early because of insufficient recruitment. In the end, only 52 patients (age 79±7 years; women 54%; NYHA III-IV 27%; median STS score 3.3%) were included in the study. During follow-up (mean: 14±7 months), the primary endpoint occurred in 12 (23%) patients. Compared with MT, AVR was not associated with a significant prognostic benefit (events: 5/26 (19%) vs 7/26 (27%) (HR 0.76, 95% CI 0.24 to 2.39, p=0.63). During follow-up, 11 (42%) patients in the MT group developed class I criteria for AVR or severe symptoms justifying a cross-over to the AVR group.
Conclusions: Because of the small number of included patients and short follow-up the ROTAS trial was underpowered and unable to demonstrate a difference in the study endpoint between treatment arms. In patients in the MT arm, a regular echocardiographic and clinical assessment might be useful to disclose those developing class I indications of AVR or severe AS-related symptoms.
期刊介绍:
Heart is an international peer reviewed journal that keeps cardiologists up to date with important research advances in cardiovascular disease. New scientific developments are highlighted in editorials and put in context with concise review articles. There is one free Editor’s Choice article in each issue, with open access options available to authors for all articles. Education in Heart articles provide a comprehensive, continuously updated, cardiology curriculum.