医学
主动脉瓣置换术
试验装置豁免
狭窄
主动脉瓣狭窄
临床试验
主动脉瓣
随机对照试验
人口
外科
冲程(发动机)
纳入和排除标准
内科学
心脏病学
机械工程
环境卫生
工程类
替代医学
病理
作者
Moritz Seiffert,Reinhard Vonthein,Helmut Baumgartner,Michael A. Borger,Yeong‐Hoon Choi,Volkmar Falk,Norbert Frey,Andreas Hagendorff,Christian Hagl,Christian W. Hamm,Inke R. König,Ulf Landmesser,Steffen Maßberg,Hermann Reichenspurner,Holger Thiele,Raphael Twerenbold,Maren Vens,Thomas Walther,Andreas Ziegler,Jochen Cremer,Stefan Blankenberg
出处
期刊:Eurointervention
[Europa Digital and Publishing]
日期:2023-10-01
卷期号:19 (8): 652-658
被引量:2
标识
DOI:10.4244/eij-d-23-00232
摘要
Transcatheter aortic valve implantation (TAVI) has become the preferred treatment option for patients with severe aortic stenosis at increased risk for surgical aortic valve replacement (SAVR) and for older patients irrespective of risk. However, in younger, low-risk patients for whom both therapeutic options, TAVI and SAVR, are applicable, the optimal treatment strategy remains controversial, as data on long-term outcomes remain limited. The DEDICATE-DZHK6 Trial is an investigator-initiated, industry-independent, prospective, multicentre, randomised controlled trial investigating the efficacy and safety of TAVI compared to SAVR in low- to intermediate-risk patients aged 65 years or older. To evaluate both treatment strategies, approximately 1,404 patients determined eligible for both TAVI and SAVR by the interdisciplinary Heart Team were randomised to TAVI or SAVR. Broad inclusion and strict exclusion criteria targeted an all-comers patient population. Procedures were performed according to local best practice with contemporary routine medical devices. The primary endpoints are a composite of mortality or stroke at 1 year and 5 years in order to incorporate midterm efficacy results and complement early safety data. Primary outcomes will be tested sequentially for non-inferiority and superiority. The DEDICATE-DZHK6 Trial has been designed to mirror clinical reality for the treatment of severe aortic stenosis and provide unique information on overall outcomes after TAVI and SAVR that can be directly applied to clinical routines. Its results will help further define optimal treatment strategies for low- to intermediate-risk patients in whom both TAVI and SAVR are currently advisable.
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