Coronary Heart Disease, Diabetes Mellitus
Conditions
Keywords
Optical coherence tomography, Drug eluting stent, Coronary heart 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. Furthermore, several studies have demonstrated the feasibility of OCT to quantitatively evaluate the surface coverage and stent conditions in the follow up after PCI .
Interventions
DEVICEPolymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Polymer-based sirolimus-eluting stent( Cypher, Cordis ) and Polymer-free paclitaxel-eluting stent (YinYi ),randomly implanted in two vessels of one patients
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 two significant (\>70%) angiographic stenosis lesions in different native coronary vessels 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 |
|---|---|---|
| Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT. | 6-month | Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of hsCRP concentration between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation | at every 8-hour in first 24-hour after stent implantation | Comparison of hsCRP concentration between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation |
| Comparison of the malapposition, neointimal heterogeneity and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT | 6-month | Comparison of the malapposition, neointimal heterogeneity and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT |
| Comparison of surface coverage, late stent malapposition, neointimal heterogeneity and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT | 6-month | Comparison of surface coverage, late stent malapposition, neointimal heterogeneity and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT |
| Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in Non-DM after stenting using OCT | 6-month | Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in Non-DM after stenting using OCT |
| Comparison of troponin-I levels between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation | at every 8-hour in first 24-hour after stent implantation | Comparison of troponin-I levels between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation |
| Comparison of the surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT | 12-month | Comparison of the surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT |
| Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT | 12-month | Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT |
| TLR/TVR | 12-month | TLR/TVR |
| MACE | 12-month | MACE |
| QCA parameters and IVUS parameters for binary restenosis, late lumen loss. | 6-month | QCA parameters and IVUS parameters for binary restenosis, late lumen loss. |
Countries
China
Outcome results
None listed