Standardized definitions and clinical endpoints in carotid artery and supra-aortic trunk revascularization trials.
BACKGROUND
Endovascular therapy has emerged as a promising alternative to open surgery for stroke prevention in patients with obstructive disease of the supra-aortic arteries. Although most previous studies have used similar safety and efficacy endpoints, differences in definitions, timing of assessments, and standards of reporting have hampered direct comparisons across various trials.


RESULTS
The DEFINE group, an informal collaboration of multidisciplinary physicians, involved in the therapy of patients with obstructive disease of the supra-aortic arteries in Europe and the United States reviewed the current literature and, after extensive correspondence and meetings, proposed the definitions outlined in the present manuscript. Three meetings including all authors of the manuscript, along with representatives of the United States Food and Drug Administration (FDA) and commercial device manufacturers were held in Barcelona, Spain, in May 2008, in Munich, Germany, in July 2008, and in New York in November 2008. The proposed definitions encompass baseline clinical and anatomic characteristics, clinical and radiologic outcomes, complications, standards of reporting, and timing of assessment.


CONCLUSIONS
Considering the broad consensus between the multidisciplinary scientific members and the regulatory authorities, the proposed definitions are expected to find adoption in future clinical investigations. These definitions can be applied to both endovascular and open surgery trials and will allow reliable comparisons between these two revascularization methods.
Nedeltchev
Krassen
K
Department of Neurology, Triemli Hospital, Zurich, Switzerland. krassen.nedeltchev@triemli.stzh.ch
Pattynama
Peter M
PM
Biaminoo
Giancarlo
G
Diehm
Nicolas
N
Jaff
Michael R
MR
Hopkins
L Nelson
LN
Ramee
Stephen
S
van Sambeek
Marc
M
Talen
Aly
A
Vermassen
Frank
F
Cremonesi
Alberto
A
D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000628:therapy*; D016893:Carotid Stenosis / Q000175:diagnosis / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D057510:Endovascular Procedures / Q000009:adverse effects / Q000592:standards* / Q000706:statistics & numerical data; D023381:Endpoint Determination / Q000592:standards*; D005060:Europe; D006801:Humans; D012720:Severity of Illness Index; D009626:Terminology as Topic; D016896:Treatment Outcome; D014481:United States