Consensus on definitions of clinical endpoints: neurointervention trials

Summary

Acute and long-term neurological dysfunction including ischemic stroke remains an important complication of cardiovascular interventions. Lack of consistency in the neurological evaluation of patients involved in cardiovascular device trials and limited guidelines on trial protocols for neurological endpoints have made it challenging for clinicians and trialists to identify, evaluate, and report neurological complications following cardiovascular interventions. The Neurologic Academic Research Consortium (NeuroARC) classifies neurological events into 3 types based on clinical and neuroradiological examination; and categorizes cardiovascular interventions into safety and effectiveness trials based on the nature of the intervention and the associated neurological endpoints. Baseline and follow-up evaluation with valid neuropsychological tests and dedicated neuroimaging with diffusion-weighted magnetic resonance imaging are necessary to accurately characterize neurological events and their underlying mechanism of injury. Long-term follow-up is ideally required for a better understanding of differences in outcomes including long-term disability and morality, and cognitive impairment, especially in patients with subclinical neurological injury.

Introduction

Stroke is one of the most devastating complications of any surgical or catheter-based cardiovascular intervention, and patients consider stroke a worse outcome than death.11. Ahmad Y, Nijjer S, Cook CM, El-Harasis M, Graby J, Petraco R, Kotecha T, Baker CS, Malik IS, Bellamy MF, Sethi A, Mikhail GW, Al-Bustami M, Khan M, Kaprielian R, Foale RA, Mayet J, Davies JE, Francis DP and Sen S. A new method of applying randomised control study data to the individual patient: A novel quantitative patient-centred approach to interpreting composite end points. Int J Cardiol. 2015;195:216-24. Link Despite the current advances in acute stroke care, it is associated with significant mortality and morbidity contributing to approximately 6.55 million deaths and 143 million disability-adjusted life years worldwide each year.22. Roth Gregory A, Mensah George A, Johnson Catherine O, Addolorato G, Ammirati E, Baddour Larry M, Barengo Noël C, Beaton Andrea Z, Benjamin Emelia...