Coronary Artery Disease, Diabetes Mellitus
Conditions
Keywords
Optical coherence tomography, Drug eluting stent, Coronary Artery Disease, Diabetes Mellitus
Brief summary
Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis. Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI) are poor in patients with DM compared with those without DM. Autopsy study has shown delayed neointimal healing with inadequate endothelialization and persistent stent surface fibrin deposition after DES implantation in DM patients. This might partially contribute to the high risk of late stent thrombosis. YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with micro porous surface. However, limited data is available in vivo about the surface coverage after stent implantation in DM patients because of lack of sensitive imaging modalities. Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound（IVUS）that allows high-resolution tomographic intravascular imaging. Furthermore, several studies have demonstrated the feasibility of OCT to quantitatively evaluate the surface coverage and stent conditions in the follow up after PCI . Therefore, the aim of this study was to analyze the surface coverage and late malapposition after two types of DES implantation in DM patients compared with non-DM patients by using OCT and IVUS
Detailed description
Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis. Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI) are poor in patients with DM compared with those without DM. Autopsy study has shown delayed neointimal healing with inadequate endothelialization and persistent stent surface fibrin deposition after DES implantation in DM patients. This might partially contribute to the high risk of late stent thrombosis. YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with micro porous surface. However, limited data is available in vivo about the surface coverage after stent implantation in DM patients because of lack of sensitive imaging modalities. Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound（IVUS）that allows high-resolution tomographic intravascular imaging. Therefore, the aim of this study was to analyze the surface coverage and late malapposition after two types of DES implantation in DM patients compared with non-DM patients by using OCT and IVUS
Interventions
DEVICEDevice: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Cypher stent or YinYi stent randomly implanted in coronary artery disease
Sponsors
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria： 1. Age : 18-75Y 2. Patients diagnosed as type 2 DM or non-DM. Angiographic Inclusion Criteria： 1. Patients were considered eligible if they have one significant (\>70%) angiographic stenosis lesions in native coronary vessel by CAG. 2. Each target is de novo lesion that can be treated with 1-2 stents. 3. Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent)implantation | 6 months | To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent)implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation | 12 months | To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation |
| To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation | 6 months | To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation |
| To investigate the differences of surface coverage pattern，the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients | 6 and 12 months. | To investigate the differences of surface coverage pattern，the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients |
| To investigate the differences of surface coverage pattern，malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients | 6 and 12 months. | To investigate the differences of surface coverage pattern，malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients |
Countries
China
Outcome results
None listed