Cardialysis, Rotterdam, The Netherlands.
Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.
学术研究联盟（ARC）-2 计划重新审视了 2007 年提出的冠状动脉器械试验中的临床和血管造影终点定义，以使它们更适合于包括日益复杂的病变和患者人群的临床试验，并纳入生物可吸收血管支架等新型器械。此外，还提出了在临床试验中纳入患者相关结局的建议。ARC-2 是美国和欧洲的学术研究组织、器械制造商以及欧洲、美国和亚洲监管机构之间的合作努力。召开了几次现场会议，讨论了过去十年中器械领域以及临床试验和监管途径的变化。本文件中的基于共识的终点定义得到了本文件利益相关者的认可，并强烈倡导用于临床试验目的。本 ARC-2 文件为冠状动脉器械试验提供了进一步的终点定义标准化，纳入了技术和知识的进步。它们的使用将有助于解释试验结果和研究之间的比较，从而促进这些器械的安全性和有效性的评估。
