The investigators aim to investigate the effect of oral nicorandil on neointima after coronary drug-eluting stent implantation in patients with diabetic mellitus.
In the era of bare metal stent (BMS), the restenosis rate was about 25%. The introduction of drug-eluting stent (DES) reduces restenosis rate to 4%-10%. Neointimal hyperplasia and restenosis remain to be problems after DES implantation. Besides, DES causes an increase in uncovered struts, late stent thrombosis, neoatherosclerosis, and heterogeneous neointima. Diabetes mellitus (DM) results in increased risk for atherosclerosis, in-stent restenosis, neoatherosclerosis and late-stent thrombosis. Nicorandil, a hybrid of adenosine triphosphate-sensitive potassium (K-ATP) channel opener and nitrates, has been shown to reduce target vessel revascularization after stent implantation, target lesion revascularization after rotational atherectomy, and restenosis in patients undergoing percutaneous coronary intervention (PCI). Intracoronary optical coherence tomography(OCT) has emerged as a high-resolution imaging method for analysis of neointima that grows over the stent. We aim to examine the effect of nicorandil on the neointima after coronary DES implantation in patients with unstable angina and DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGNeointimal thickness (in μm)
Neointimal thickness is defined as the distance between the stent strut and lumen surface.
Time frame: 9 month
Neointimal area
Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.
Time frame: 9 month
number of uncovered stent struts
Time frame: 9 month
percent of uncovered stent struts
Time frame: 9 month
characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima)
The characteristics of neointimal hyperplasia will be assessed and classified into three patterns according to the neointimal signal intensity.
Time frame: 9 month
number of in-stent neoatherosclerosis
Time frame: 9 month
angiographic late lumen loss (in mm)
Late lumen loss is the difference of baseline and follow-up minimal luminal diameters.
Time frame: 9 month
rate of restenosis (in %)
Time frame: 9 month
number of major adverse cardiovascular events
Time frame: 9 month
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