Coronary Artery Disease Clinical Trial
Official title:
RELATionship bEtween Lesion-level Invasive Fractional Flow Reserve AND Endothelial Wall Shear Stress the RELATE FFR and WSS Study
This study, designed as a retrospective registry, aims to investigate the relationship and potential interplay between fractional flow reserve (FFR) or instantaneous waves free ratio (iFR) with wall shear stress (WSS) in the context of intermediate coronary stenosis.
BACKGROUND AND RATIONALE Despite great advances in atherothrombosis science, the complex
interplay of factors leading to plaque progression remains elusive. Specifically, the
dynamics leading a stable plaque towards rupture and over imposed thrombosis are largely
speculative. Wall shear stress (WSS), the mechanical force elicited by blood flow on the
vessel walls, is emerging as a potent trigger of bio-humoral processes eventually leading to
endothelial damage, plaque progression and destabilization.
Fractional flow reserve (FFR), assessing the aggregate hemodynamical significance of a
stenosis on the subtended myocardium, stratifies the risk of major adverse cardiovascular
events and reduces their occurrence when used to guide revascularization. While this event
reduction is mainly driven by ischemia-caused urgent revascularization, it is emerging that
FFR-guided revascularization may also reduce myocardial infarction.
While the physiological relationship between a lesion's FFR and resulting ischemia in the
subtended myocardium is intuitive, the mechanisms linking FFR to atherothrombosis are less
clearly defined.
Lesions with lower FFR are associated with adverse atherosclerotic plaque characteristics
(APCs), however, the causative nexus of this relationship is not well established. It has
been proposed both that the physiological base for this relation underlies in disturbed
lesion hemodynamics, occurring at a greater extent as the degree of functional obstruction
increases (i.e. FFR reduction drives APCs), and that APCs directly impair the vessel's
vasodilatory reserve resulting in detrimental hyperemic perfusion (i.e. APCs drive FFR
reduction).
WSS measures the regional tangential hemodynamic forces produced by viscous blood flow on the
endothelium, which is established drivers of plaque progression and transformation toward an
adverse plaque phenotype. Intriguingly, WSS may thus represent the missing link between FFR
and atherothrombosis.
Few studies have focused on the interplay of FFR and WSS and the provided results are
inconclusive (9, 10). This relation remains thus to be fully characterized.
This study will investigate the association of aggregate with regional hemodynamic forces as
defined by the lesion-level relation of FFR or instantaneous wave-free ratio (iFR) and
regional WSS across the lesion.
STUDY DESIGN This is a retrospective observational multi-center study, including consecutive
patients who underwent coronary angiography at for symptom/ischemia-driven, suspected stable
coronary artery disease or for acute coronary syndromes (ACS) with evidence of at least one
lesion with 30-90% diameter-stenosis, that underwent subsequent iFR/FFR assessment.
Coronary angiography of the screened patients will be retrospectively evaluated by an
experienced Interventional cardiologist and, if deemed suitable for baseline angiographic
reconstruction will be included in this registry.
3-dimensional (3D) geometric reconstructions of each patient's target vessel will be created
by using end-diastolic angiographic projections at least 25° apart. Computational fluid
dynamics models will be applied to derive regional WSS values across the stenosis.
Clinical baseline characteristics and angiographic features obtained by visual and functional
assessment, and 3-D reconstruction and computation, along with major adverse cardiovascular
events, will be collected in a dedicated electronic form.
The analysts performing angiographic 3-D reconstruction and WSS computations will be blinded
to FFR/iFR values and clinical data.
STUDY ENDPOINTS This study will investigate the association of aggregate and regional
hemodynamic forces as established by the lesion-level relation of FFR/iFR with regional WSS
across the lesion.
The association of regional WSS with major cardiovascular adverse events at available
follow-up will be further evaluated to assess if lesion-level WSS might predict overall
patient-level outcomes (in case of more than one lesion for a single patient, the lesion with
the highest WSS will be considered for this analysis).
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