Reporting standards for angioplasty and stent-assisted angioplasty for intracranial atherosclerosis.

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 Neurolnterventional Surgery, Society of Interventional Radiology; Joint Section on Cerebro-vascular 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.

Reporting standards for angioplasty and stent-assisted angioplasty for intracranial atherosclerosis.

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. CONCLUSIONS: 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.

Surgery to prevent stroke. High hopes and deep disappointment.

Carotid endarterectomy and EC/IC bypass grafting have been widely adopted for patients considered at risk from stroke, without good evidence of efficacy. Unjustified claims for surgery usually derive from overestimating the dangers of the disease without surgery, while perioperative risks are underestimated. Inadequate follow-up and choosing irrelevant outcome measures often add to the confusion. All these factors apply to surgery for stroke. A trial of EC/IC bypass in 1,377 patients from three continents took 8 years to complete and showed no benefit in patients randomized to surgery. Reluctance to accept this result led to detailed critiques of this trial in several journals, largely based on the discovery that many patients had been operated on in some centers without having been randomized. In reply, the investigators showed that these cases did not affect the "resounding negativity of the results." Lack of good data about the prognosis of patients with TIAs or minor strokes was the fundamental reason for so much misplaced surgical effort. This applies equally to carotid endarterectomy, for which large trials are currently being completed. Had there been a reliable data base of patients at risk of stroke, prospectively collected and followed, the efficacy of these two operations could have been determined much sooner, and inappropriate diffusion might have been prevented.