Clinical trial NCT01021930: Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT
Official title: Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for Surface Coverage After Two Types of Drug-eluting Stent Implantation (A Pilot Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Heart Disease
Diabetes Mellitus
Keywords: Optical coherence tomography
Drug eluting stent
Coronary heart disease
Diabetes mellitus
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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 Exclusion Criteria：

1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
2. Life expectancy \<12 months due to another medical condition.
3. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
4. Creatinine level more than 2.0mg/dL or ESRD.
5. Severe hepatic dysfunction (more than 3 times normal reference values).
6. Planned surgery procedure≤12 months post-index procedure.
7. Known allergy to stainless steel.
8. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
9. Patient is not clinically appropriate for OCT evaluation in the opinion of investigator.

Angiographic Exclusion Criteria：

1. Study lesion is ostial in location (within 3.0 mm of vessel origin).
2. Study lesion involving arterial segments with highly tortuous anatomy.
3. Complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).

Primary outcomes:
measure: Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT.
timeFrame: 6-month
Secondary outcomes:
measure: Comparison of troponin-I levels between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation
timeFrame: at every 8-hour in first 24-hour after stent implantation
measure: Comparison of hsCRP concentration between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation
timeFrame: at every 8-hour in first 24-hour after stent implantation
measure: Comparison of the malapposition, neointimal heterogeneity and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT
timeFrame: 6-month
measure: Comparison of surface coverage, late stent malapposition, neointimal heterogeneity and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT
timeFrame: 6-month
measure: 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
timeFrame: 6-month
measure: QCA parameters and IVUS parameters for binary restenosis, late lumen loss.
timeFrame: 6-month
measure: 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
timeFrame: 12-month
measure: Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT
timeFrame: 12-month
measure: 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
timeFrame: 12-month
measure: QCA parameters and IVUS parameters for binary restenosis, late lumen loss.
timeFrame: 12-month
measure: TLR/TVR
timeFrame: 12-month
measure: MACE
timeFrame: 12-month
Other outcomes:
Locations:
city: Harbin
country: China
facility: The second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: