Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.
Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.
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DOI：
10.1093/eurheartj/ehq406
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发表时间：
2011-01
影响因子：
39.3
通讯作者：
Serruys PW
中科院分区：
文献类型：
--
作者：
Leon MB;Piazza N;Nikolsky E;Blackstone EH;Cutlip DE;Kappetein AP;Krucoff MW;Mack M;Mehran R;Miller C;Morel MA;Petersen J;Popma JJ;Takkenberg JJ;Vahanian A;van Es GA;Vranckx P;Webb JG;Windecker S;Serruys PW
为经导管主动脉瓣置入术(TAVI)的重要临床终点提出标准化的共识定义，以努力提高临床研究的质量，并使临床试验之间能够进行有意义的比较。通过代表公众健康的同行评议出版物，使TAVI临床研究中的所有利益相关者都能获得这些共识定义。经导管主动脉瓣置入术可能为许多严重的主动脉狭窄患者提供一种有价值的微创治疗，自2002年引入医学界以来，手术方法有了爆炸性的增长。将TAVI整合到日常临床实践中应该以学术活动为指导，这需要在进行良好的临床试验期间协调和结构化的数据收集、解释和报告过程。瓣膜学术研究联盟在美国和欧洲的学术研究组织和专业学会(心脏病学和心脏外科)之间建立了独立的合作关系。2009年9月在加利福尼亚州旧金山和2009年12月在荷兰阿姆斯特丹举行的两次会议，包括主要内科专家、美国食品和药物管理局(FDA)和设备制造商的代表，重点讨论了制定一致的终点定义和共识建议，以便在TAVI临床研究计划中实施。制定终点定义时的重要考虑因素包括：(I)尊重外科瓣膜指南的历史遗产；(Ii)确定与临床事件相关的病理生理机制；(Iii)强调临床相关性。制定了以下终点的共识标准：死亡率、心肌梗死、中风、出血、急性肾损伤、血管并发症和人工瓣膜性能。还建议为TAVI的安全性和有效性提供复合终点。尽管共识标准总是包括某些任意的特征，但为TAVI临床研究制定具体定义的有组织的多学科过程应该提供跨研究的一致性，以促进对这一新的基于导管的重要疗法的评估。本文中描述的基础广泛的共识终点定义可能对监管和临床试验目的有用。
To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended. Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes.
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影响因子：
13.2
作者：
Abosaif, NY;Tolba, YA;El Nahas, AM
通讯作者：
El Nahas, AM
影响因子：
6.1
作者：
Bell, M;Liljestam, E;Martling, CR
通讯作者：
Martling, CR
影响因子：
6.1
作者：
Aregger, Fabienne;Wenaweser, Peter;Frey, Felix J.
通讯作者：
Frey, Felix J.
影响因子：
24
作者：
Clavel, Marie-Annick;Webb, John G.;Rodes-Cabau, Josep
通讯作者：
Rodes-Cabau, Josep
影响因子：
4.3
作者：
Chaikof, EL;Blankensteijn, JD;Kent, KC
通讯作者：
Kent, KC