Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials
Alexandra J. LanskySteven R. MesséAdam M. BrickmanMichael G. DwyerH. Bart van der WorpRonald M. LazarCody PietrasKevin J. AbramsEugène McFaddenNils PetersenJeffrey N. BrowndykeBernard PrendergastVivian G. NgDonald E. CutlipSamir KapadiaMitchell W. KrucoffAxel LinkeClaudia S. MoyJoachim SchöferGerrit-Anne van EsRenu VirmaniJeffrey J. PopmaMichael K. ParidesSusheel KodaliMichel BilelloRobert ZivadinovJoseph G. AkarKaren L. FurieDaryl R. GressSzilárd VörösJeffrey W. MosesDavid M. GreerJohn K. ForrestDavid R. HolmesA. Pieter KappeteinMichael J. MackAndreas Baumbach
Why the study?
Diverse neurological endpoint definitions and ascertainment methods in cardiovascular clinical trials create uncertainty regarding procedure-attributable neurological risk and lead to inconsistent evaluation of neuroprotective therapies.
Key Points
- This research aims to define standardized neurological endpoints for assessing risks and outcomes in cardiovascular clinical trials.
- Establishment of consensus definitions and classifications for neurological endpoints by the Neurologic Academic Research Consortium.
- Evaluation of existing endpoint diversity and its impact on clinical trial outcomes.
- Recommendation for consistent assessment methods to capture the full spectrum of neurovascular injury.
- Increased clarity in the evaluation of neurological risks associated with cardiovascular procedures.
- Improved consistency in defining and assessing neurological outcomes, enhancing preventive therapy evaluations.
PICO
P
Population
Neurological complications in cardiovascular trials
Standardized neurological endpoints proposed by the Neurologic Academic Research Consortium aim to improve the evaluation of neurological risks and preventive therapies in cardiovascular trials.
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Answers are grounded in this paper and cite their sources.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The current stroke definitions used in cardiovascular trials focus on the most extreme, devastating strokes, which are only one component of a spectrum of brain injury that is relevant to patients with cardiovascular disease.”
“Until now, many studies evaluating the safety of TAVR and other cardiovascular procedures only recorded the most devastating strokes, which meant that doctors—and their patients—were unaware of the full risk potential. We hope this paper will cause researchers to report their findings in a more comprehensive and consistent way so that clinicians can properly interpret the results to provide the best care to patients.”
“As even the smallest damage to particular parts of the brain can impact a patient's memory and day-to-day ability to function, my colleagues and I have grown increasingly concerned that safety evaluations of the newer cardiovascular procedures only evaluate the extreme life-threatening forms of brain damage. This paper outlines the need to use and report more modern and sensitive measures to evaluate brain injury related to cardiac procedures.”
Implication
Enhances patient counseling on full neurological risks of CV procedures; extends standardized endpoints to improve trial consistency and comparability.
Abstract
Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.
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Cite This Study
Lansky et al. (2017) conducted a review in Neurological complications in cardiovascular trials. The Neurologic Academic Research Consortium proposes standardized definitions and assessments for neurological endpoints to improve the evaluation of safety and effectiveness in cardiovascular trials.