Coronary Artery Disease Clinical Trial
Official title:
Effect of Permanent Internal Mammary Artery Occlusion on Extracardiac Coronary Collateral Supply
Coronary artery disease and the benefit of bypasses:
Despite considerable advances in medicine, cardiovascular diseases remain the number one
cause of death globally, primarily consequence of myocardial infarction (MI). Coronary
collaterals exert a protective effect by providing an alternative source of blood flow to a
myocardial territory potentially affected by an acute coronary occlusion. Coronary
collaterals represent pre-existing inter-arterial anastomoses and as such are the natural
counter-part of surgically created bypasses. Sufficient coronary collaterals have been shown
to confer a significant benefit in terms of overall mortality and cardiovascular events. In
this regard, the concept of augmenting coronary collateral function as an alternative
treatment strategy to alter the course of CAD, as well as to control symptoms, is
attractive.
Durable promotion of coronary collateral circulation:
Before the advent of coronary artery bypass grafting, permanent augmentation of coronary
collateral supply by a single structural modification has already been attempted. Bilateral
ligation of the internal mammary arteries (IMA) was performed in CAD patients to alleviate
angina pectoris and electrocardiographic (ECG) signs of ischemia. The prevalent in vivo
function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for
the first time - been recently demonstrated by our research group. The acute functional
changes observed in response to temporary distal IMA balloon occlusion are expected to
result in larger chronic structural adaptations of the IMA-to-coronary-artery connections
when the distal IMA is permanently occluded. In contrast to the previously employed
arteriogenic approaches in humans, the attractiveness of such an intervention lies in the
potential durability of the effect.
In a first step, catheter-based IMA occlusion ought to be conceptually investigated in the
setting of the less frequently grafted right IMA among patients with ischemia in the right
coronary artery territory.
Coronary artery disease and the benefit of bypasses:
Despite considerable advances in medicine, cardiovascular diseases remain the number one
cause of death globally, primarily consequence of myocardial infarction (MI). Although
widely used in stable CAD, percutaneous coronary intervention (PCI) has not been shown to
reduce the incidence of myocardial infarction or death. In contrast, coronary artery bypass
grafting (CABG) significantly reduced rates of death and myocardial infarction compared to
PCI. Similarly, coronary collaterals exert a protective effect by providing an alternative
source of blood flow to a myocardial territory potentially affected by an acute coronary
occlusion. Coronary collaterals represent pre-existing inter-arterial anastomoses and as
such are the natural counter-part of surgically created bypasses. Sufficient coronary
collaterals have been shown to confer a significant benefit in terms of overall mortality
and cardiovascular events. In this regard, the concept of augmenting coronary collateral
function as an alternative treatment strategy to alter the course of CAD, as well as to
control symptoms, is attractive.
Durable promotion of coronary collateral circulation:
While a multitude of interventions has been shown to be effective in collateral growth
promotion, so far, the effect of current interventions is only temporary and therefore
recurrent application is necessary to sustain the level of collaterals. However, before the
advent of coronary artery bypass grafting, permanent augmentation of coronary collateral
supply by a single structural modification has already been attempted. Bilateral ligation of
the internal mammary arteries (IMA) was performed in CAD patients to alleviate angina
pectoris and electrocardiographic (ECG) signs of ischemia. The prevalent in vivo function of
natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for the first
time - been recently demonstrated by our research group. Levels of collateral function and
myocardial ischemia were determined during two coronary balloon occlusions, the first with,
the second without distal IMA balloon occlusion. Coronary collateral function, was
consistently increased in the presence vs the absence of distal ipsilateral IMA balloon
occlusion. These findings were corroborated by the observed reduction in ischemia.
Conversely, with distal contralateral IMA occlusion, collateral function and ECG signs of
ischemia remained unchanged. The acute functional changes observed in response to temporary
distal IMA balloon occlusion are expected to result in larger chronic structural adaptations
of the IMA-to-coronary-artery connections when the distal IMA is permanently occluded. In
contrast to the previously employed arteriogenic approaches in humans, the attractiveness of
such an intervention lies in the potential durability of the effect.
In a first step, catheter-based IMA occlusion ought to be conceptually investigated in the
setting of the less frequently grafted right IMA among patients with ischemia in the right
coronary artery territory.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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