Clinical Endpoints in Peripheral Endovascular Revascularization Trials: a Case for Standardized Definitions

被引：116

作者：

Diehm, N. ^{[1
]}

Pattynama, P. M. ^{[2
]}

Jaff, M. R. ^{[3
]}

Cremonesi, A. ^{[4
]}

Becker, G. J. ^{[5
,6
]}

Hopkins, L. N. ^{[7
]}

Mahler, F. ^{[1
]}

Talen, A. ^{[8
]}

Cardella, J. F. ^{[9
]}

Ramee, S. ^{[10
]}

van Sambeek, M. ^{[11
]}

Vermassen, F. ^{[12
]}

Biamino, G. ^{[4
]}

机构：

[1] Univ Bern, Inselspital, Div Clin & Intervent Angiol, Swiss Cardiovasc Ctr, CH-3010 Bern, Switzerland

[2] Erasmus Univ, Med Ctr, Dept Radiol, Rotterdam, Netherlands

[3] Harvard Univ, Massachusetts Gen Hosp, Sch Med, Vasc Ctr, Boston, MA USA

[4] Villa Maria Cecilia Hosp, Grp Villa Maria Endovasc, Cotignola, Italy

[5] Univ Arizona, Coll Med, Sarver Heart Ctr, Tucson, AZ 85721 USA

[6] Univ Arizona, Coll Med, Dept Radiol, Vasc & Intervent Sect, Tucson, AZ 85721 USA

[7] Sch Med & Biomed Sci, Dept Neurosurg, Buffalo, NY USA

[8] Genae Associates Nv, Antwerp, Belgium

[9] Tufts Univ, Sch Med, Dept Radiol, Springfield, MA 01199 USA

[10] Ochsner Heart & Vasc Inst, New Orleans, LA USA

[11] Catharina Hosp, Dept Surg, Eindhoven, Netherlands

[12] Univ Hosp, Dept Vasc Surg, Ghent, Belgium

来源：

EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY | 2008年 / 36卷 / 04期

关键词：

Reporting standards; Outcome analysis; Clinical improvement; Angiography;

D O I：

10.1016/j.ejvs.2008.06.020

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

Background: 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. Methods and results: 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 goat was to arrive at a broad based consensus for baseline and endpoint definitions in peripheral endovascular revascularization trials for chronic tower 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 tower 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. Conclusion: 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 tower limb ischemia as well as for regulatory purposes. (C) 2008 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

引用

页码：409 / 419

页数：11