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Shear Stress

Abstract

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Prediction of progression of coronary artery disease and clinical outcomes using vascular profiling of endothelial shear stress and arterial plaque characteristics: the PREDICTION Study Role of endothelial dysfunction in determining angina after percutaneous coronary intervention: Learning from pathophysiology to optimize treatment High Coronary Shear Stress in Patients With Coronary Artery Disease Predicts Myocardial Infarction Angiographic derived endothelial shear stress: a new predictor of atherosclerotic disease progression Flow-Regulated Endothelial S1P Receptor-1 Signaling Sustains Vascular Development Low Endothelial Shear Stress Predicts Evolution to High-Risk Coronary Plaque Phenotype in the Future: A Serial Optical Coherence Tomography and Computational Fluid Dynamics Study Evolving understanding of the heterogeneous natural history of individual coronary artery plaques and the role of local endothelial shear stress TAVI Represents an Anti-Inflammatory Therapy via Reduction of Shear Stress Induced, Piezo-1-Mediated Monocyte Activation
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GuidelineVolume 11, Issue 9, May 2018

JOURNAL：JACC Cardiovasc Interv. Article Link

Defining Staged Procedures for Percutaneous Coronary Intervention Trials A Guidance Document

E Spitzer, E Mc Fadden, P Vranckx et al. Keywords: clinical endpoint adjudication; clinical trial; coronary revascularization; staged procedure

ABSTRACT

Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee.

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