Consensus on definitions of clinical endpoints : carotid artery and supra-aortic trunk revascularisation trials

Summary

Endovascular therapy of carotid and supra-aortic trunk obstructive disease may provide an effective and less invasive treatment in many patients and, since its introduction to the medical community, it has been considered a potential alternative to open surgery for stroke prevention and upper limb ischaemic syndromes.

The integration of carotid stenting and other endovascular strategies for supra-aortic interventions in daily clinical practice should be guided by a harmonised and structured process for data collection, interpretation and reporting during well-conducted clinical trials.

From this perspective, scientific societies, academic research bodies and key expert physicians should combine their efforts to improve the quality of clinical research in order to enable meaningful comparisons between clinical trials.

This chapter focuses on creating consistent endpoint definitions and consensus recommendations for implementation in clinical research programmes dedicated to carotid stenting and supra-aortic trunk endovascular procedures. Specific considerations in developing endpoint definitions include: (1) respect for vascular surgical guidelines; (2) identification of pathophysiological mechanisms associated with clinical events; and (3) emphasis on clinical relevance.

The proposed definitions encompass baseline clinical manifestations, anatomic characteristics, clinical and radiological outcomes, complications, standards of reporting, and timing of assessment. If, on consideration, there is broad consensus among the multidisciplinary scientific...