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 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. 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 lower limb ischemia as well as for regulatory purposes.
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 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. 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 lower limb ischemia as well as for regulatory purposes.
Authors: Karen A Hicks; James E Tcheng; Biykem Bozkurt; Bernard R Chaitman; Donald E Cutlip; Andrew Farb; Gregg C Fonarow; Jeffrey P Jacobs; Michael R Jaff; Judith H Lichtman; Marian C Limacher; Kenneth W Mahaffey; Roxana Mehran; Steven E Nissen; Eric E Smith; Shari L Targum Journal: J Nucl Cardiol Date: 2015-10 Impact factor: 5.952
Authors: Manesh R Patel; Michael S Conte; Donald E Cutlip; Nabil Dib; Patrick Geraghty; William Gray; William R Hiatt; Mami Ho; Koji Ikeda; Fumiaki Ikeno; Michael R Jaff; W Schuyler Jones; Masayuki Kawahara; Robert A Lookstein; Roxana Mehran; Sanjay Misra; Lars Norgren; Jeffrey W Olin; Thomas J Povsic; Kenneth Rosenfield; John Rundback; Fadi Shamoun; James Tcheng; Thomas T Tsai; Yuka Suzuki; Pascal Vranckx; Bret N Wiechmann; Christopher J White; Hiroyoshi Yokoi; Mitchell W Krucoff Journal: J Am Coll Cardiol Date: 2015-03-10 Impact factor: 24.094
Authors: Nathan K Itoga; Vy T Ho; Kenneth Tran; Venita Chandra; Ronald L Dalman; Edmund J Harris; Jason T Lee; Matthew W Mell Journal: Vasc Endovascular Surg Date: 2019-11-20 Impact factor: 1.089
Authors: Amine Karimi; Sanne W de Boer; Daniël A F van den Heuvel; Bram Fioole; Dammis Vroegindeweij; Jan M M Heyligers; Paul N M Lohle; Otto Elgersma; Rudolf P T Nolthenius; Jan Albert Vos; Jean-Paul P M de Vries Journal: Trials Date: 2013-03-28 Impact factor: 2.279
Authors: Gunnar Tepe; Thomas Zeller; Matej Moscovic; Jean-Marc Corpataux; Johnny Kent Christensen; Koen Keirse; Giovanni Nano; Henrik Schroeder; Christoph A Binkert; Marianne Brodmann Journal: Cardiovasc Intervent Radiol Date: 2020-10-20 Impact factor: 2.740