Reporting Standards for Angioplasty and Stent-assisted Angioplasty for Intracranial Atherosclerosis
Received 31 May 2008; received in revised form 27 October 2008; accepted 4 November 2008.
Background and Purpose
Intracranial cerebral atherosclerosis causes ischemic stroke in a significant number of patients. Technological advances over the past 10 years have enabled endovascular treatment of intracranial atherosclerotic stenosis. The number of patients treated with angioplasty or stent-assisted angioplasty for this condition is increasing. Given the lack of universally accepted definitions, the goal of this document is to provide consensus recommendations for reporting standards, terminology, and written definitions when reporting clinical and radiological evaluation, technique, and outcome of endovascular treatment using angioplasty or stent-assisted angioplasty for stenotic and occlusive intracranial atherosclerosis.
Summary of Report
This article was written under the auspices of Joint Writing Group of the Technology Assessment Committee, Society of NeuroInterventional Surgery, Society of Interventional Radiology; Joint Section on Cerebrovascular Neurosurgery of the American Association of Neurological Surgeons and Congress of Neurological Surgeons; and the Section of Stroke and Interventional Neurology of the American Academy of Neurology. A computerized search of the National Library of Medicine database of literature (PubMed) from January 1997 to December 2007 was conducted with the goal to identify published endovascular cerebrovascular interventional data in stenotic intracranial atherosclerosis that could be used as benchmarks for quality assessment. We sought to identify those risk adjustment variables that affect the likelihood of success and complications. This document offers the rationale for different clinical and technical considerations that may be important during the design of clinical trials for endovascular treatment of intracranial stenotic and occlusive atherosclerosis. Included in this guidance document are suggestions for uniform reporting standards for such trials. These definitions and standards are primarily intended for research purposes; however, they should also be helpful in clinical practice and applicable to all publications.
Conclusion
In summary, the definitions proposed represent recommendations for constructing useful research data sets. The intent is to facilitate production of scientifically rigorous results capable of reliable comparisons between and among similar studies. In some cases, the definitions contained here are recommended by consensus of a panel of experts in this writing group for consistency in reporting and publication. These definitions should allow different groups to publish results that are directly comparable.
Address correspondence to Philip M. Meyers, MD, FAHA, Associate Professor, Radiology and Neurological Surgery, Columbia University, College of Physicians & Surgeons, Clinical Director, Neuroendovascular Service, New York Presbyterian–Columbia Neurological Institute, New York, NY 10032
Dr Higashida served as a consultant to Cordis Neurovascular. Dr Nesbit received honoraria from Cordis Neurovascular and Genentech, has an ownership interest in Concentric Medical, and served as a consultant to Concentric Medical. Dr Wechsler served as a consultant to Nuevelo, Inc, and Abbott Vascular. Dr Lavine received honoraria from Cordis Neurovascular. Dr Rasmussen received honoraria from the Universities of Minnesota and Pittsburgh, Microvention/Terumo, ev3, Possis, Medical/Medrad, and Micrus, has an ownership interest in Chestnut Medical, and served as a consultant to Chestnut Medical.
ABSTRACT