Diehm N, Pattynama P M, Jaff M R, Cremonesi A, Becker G J, Hopkins L N, Mahler F, Talen A, Cardella J F, Ramee S, van Sambeek M, Vermassen F, Biamino G
Swiss Cardiovascular Center, Division of Clinical and Interventional Angiology, Inselspital, University of Bern, Freiburgstrasse, Bern, Switzerland.
Eur J Vasc Endovasc Surg. 2008 Oct;36(4):409-19. doi: 10.1016/j.ejvs.2008.06.020. Epub 2008 Aug 8.
Endovascular therapy is a rapidly expanding option for the treatment of patients with peripheral arterial disease (PAD), leading to a myriad of published studies reporting on various revascularization strategies. However, these reports are often difficult to interpret and compare because they do not utilize uniform clinical endpoint definitions. Moreover, few of these studies describe clinical outcomes from a patients' perspective.
The DEFINE Group is a collaborative effort of an ad-hoc multidisciplinary team from various specialties involved in peripheral arterial disease therapy in Europe and the United States. DEFINE's goal was to arrive at a broad based consensus for baseline and endpoint definitions in peripheral endovascular revascularization trials for chronic lower limb ischemia. In this project, which started in 2006, the individual team members reviewed the existing pertinent literature. Following this, a series of telephone conferences and face-to-face meetings were held to agree upon definitions. Input was also obtained from regulatory (United States Food and Drug Administration) and industry (device manufacturers with an interest in peripheral endovascular revascularization) stakeholders, respectively. The efforts resulted in the current document containing proposed baseline and endpoint definitions in chronic lower limb PAD. Although the consensus has inevitably included certain arbitrary choices and compromises, adherence to these proposed standard definitions would provide consistency across future trials, thereby facilitating evaluation of clinical effectiveness and safety of various endovascular revascularization techniques.
This current document is based on a broad based consensus involving relevant stakeholders from the medical community, industry and regulatory bodies. It is proposed that the consensus document may have value for study design of future clinical trials in chronic lower limb ischemia as well as for regulatory purposes.
血管内治疗是治疗外周动脉疾病（PAD）患者的一种迅速发展的选择，这导致了大量关于各种血管重建策略的已发表研究。然而，这些报告往往难以解读和比较，因为它们没有采用统一的临床终点定义。此外，这些研究中很少有从患者角度描述临床结果的。
DEFINE小组是来自欧洲和美国参与外周动脉疾病治疗的各个专业的临时多学科团队的合作成果。DEFINE的目标是就慢性下肢缺血的外周血管内血管重建试验的基线和终点定义达成广泛共识。在这个始于2006年的项目中，各个团队成员回顾了现有的相关文献。随后，召开了一系列电话会议和面对面会议以商定定义。还分别从监管机构（美国食品药品监督管理局）和行业（对外周血管内血管重建感兴趣的设备制造商）利益相关者那里获取了意见。这些努力产生了当前这份包含慢性下肢PAD的拟议基线和终点定义的文件。尽管该共识不可避免地包含了某些任意的选择和妥协，但遵循这些拟议的标准定义将为未来的试验提供一致性，从而便于评估各种血管内血管重建技术的临床有效性和安全性。
这份当前文件基于来自医学界、行业和监管机构的相关利益者的广泛共识。建议这份共识文件可能对慢性下肢缺血未来临床试验的研究设计以及监管目的具有价值。
