Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies

Objectives: The purpose of this document is to make the output of the International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT) Standardization and Validation available to medical and scientific communities, through a peer-reviewed publication, in the interest of improving the diagnosis and treatment of patients with atherosclerosis, including coronary artery disease. Background: Intravascular optical coherence tomography (IVOCT) is a catheter-based modality that acquires images at a resolution of ∼10 μm, enabling visualization of blood vessel wall microstructure in vivo at an unprecedented level of detail. IVOCT devices are now commercially available worldwide, there is an active user base, and the interest in using this technology is growing. Incorporation of IVOCT in research and daily clinical practice can be facilitated by the development of uniform terminology and consensus-based standards on use of the technology, interpretation of the images, and reporting of IVOCT results. Methods: The IWG-IVOCT, comprising more than 260 academic and industry members from Asia, Europe, and the United States, formed in 2008 and convened on the topic of IVOCT standardization through a series of 9 national and international meetings. Results: Knowledge and recommendations from this group on key areas within the IVOCT field were assembled to generate this consensus document, authored by the Writing Committee, composed of academicians who have participated in meetings and/or writing of the text. Conclusions: This document may be broadly used as a standard reference regarding the current state of the IVOCT imaging modality, intended for researchers and clinicians who use IVOCT and analyze IVOCT data

Clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound regression/progression studies

Atherosclerotic cardiovascular disease is a leading cause of morbidity and mortality despite the widespread use of established medical therapies. This has prompted the search to identify new therapeutic approaches to achieve more effective prevention of cardiovascular events. Considerable interest has focused on the role of surrogate markers of therapeutic efficacy in the early evaluation of novel anti-atherosclerotic therapies. Monitoring changes in the extent of coronary atherosclerosis with intravascular ultrasound (IVUS) has been increasingly employed in clinical trials to assess progression and regression of atherosclerosis. This is based on the pivotal role that atherosclerotic plaque plays in the natural history of cardiovascular disease and the acceptance of validated arterial imaging approaches including coronary angiography and carotid intimal-medial thickness by regulatory authorities. The ability to generate high-resolution imaging of the entire thickness of the co

Heparin infusion prior to stenting (HIPS) trial : final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia

Local delivery of pharmacologic agents or genes at the site of angioplasty is a promising approach to reduce restenosis. However, there are unresolved questions concerning the safety and feasibility of local vascular delivery in clinical practice as well as the efficacy of delivered drug. To this end, the safety, feasibility, and efficacy of local delivery of heparin were evaluated in the Heparin Infusion Prior to Stenting (HIPS) trial