Proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibodies (anti-PCSK9) significantly reduce the serum LDL-C level, leading to a regression of the coronary epicardial plaque demonstrated by intracoronary ultrasonography (IVUS), as well as cardiovascular events (CV) in patients with atherosclerotic CV disease treated with statin. The impact of PCSK9 inhibition on coronary microcirculation has never been assessed. However, microvascular coronary dysfunction (CMVD) is a powerful prognostic marker, irrespective of conventional CV risk factors, but also of the severity of the epicardial coronary involvement detected during coronary angiography. The investigators hypothesized that anti-PCSK9 would decrease CMVD, measured by the microcirculatory resistance index (MRI) during coronary angioplasty (Percutaneous coronary intervention, PCI) in patients with myocardial ischemia proved in myocardial scintigraphy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
3 injections of evolocumab 140 milligrams performed within 30 minutes and self-administered (subcutaneously in the abdomen, thigh, or upper arm)
Grenoble University Hospital
Grenoble, France
RECRUITINGImpact of a PCSK9 inhibitor treatment on coronary microvascular dysfunction (CMVD) at 4 weeks in patients with atherosclerotic cardiovascular disease.
Index of microcirculatory resistance (IMR), measured during invasive coronary angiography and expressed in mmHg.s
Time frame: 4 weeks
Impact of a PCSK9 inhibitor treatment on soluble VE-cadherin rate (sVE).
Measurement of sVE rate at baseline and four weeks after treatment with evolocumab or without treatment.
Time frame: 4 weeks
Impact of a PCSK9 inhibitor treatment on brachial hyperemia (HB).
Variation of the luminal diameter of the humeral artery with baseline and four weeks after treatment with evolocumab or without treatment.
Time frame: 4 weeks
Impact of a PCSK9 inhibitor treatment on the rate of peri-procedural myocardial infarction.
Troponin I level after PCI (peri-procedural myocardial pain will be defined as a post-angioplasty troponin level 10 times higher than the 99th percentile of troponin I).
Time frame: 4 weeks
Correlations between invasive and non-invasive (myocardial scintigraphy - myocardial perfusion entropy (MPE), concentration of sVE, HB) measurements of coronary microvascular dysfunction.
IMR, MPE, sVE and the variation of the luminal diameter of the humeral artery.
Time frame: 4 weeks
Correlations between the cardiovascular risk and the concentration of sVE and MPE.
Risk score, sVE rate and MPE.
Time frame: 4 weeks
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