Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT (DM-COVER)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease; Diabetes Mellitus	Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	November 2009
Estimated Primary Completion Date :	December 2010
Estimated Study Completion Date :	June 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Group A: DM; Coronary artery disease with diabetes mellitus	Device: Polymer-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
Active Comparator: Group B: Non-DM; Coronary artery disease without diabetes mellitus	Device: Polymer-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

Outcome Measures

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Primary Outcome Measures :

1. Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT. [ Time Frame: 6-month ]

Secondary Outcome Measures :

1. Comparison of troponin-I levels between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation [ Time Frame: at every 8-hour in first 24-hour after stent implantation ]
2. Comparison of hsCRP concentration between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation [ Time Frame: at every 8-hour in first 24-hour after stent implantation ]
3. Comparison of the malapposition, neointimal heterogeneity and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT [ Time Frame: 6-month ]
4. Comparison of surface coverage, late stent malapposition, neointimal heterogeneity and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT [ Time Frame: 6-month ]
5. 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 [ Time Frame: 6-month ]
6. QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 6-month ]
7. 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 [ Time Frame: 12-month ]
8. Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT [ Time Frame: 12-month ]
9. 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 [ Time Frame: 12-month ]
10. QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 12-month ]
11. TLR/TVR [ Time Frame: 12-month ]
12. MACE [ Time Frame: 12-month ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

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Contacts

Contact: Bo Yu, MD,PhD	86-0451-86605180	yubodr@163.com

Locations

China, Heilong jiang
The second Affiliated Hospital of Harbin Medical University	Recruiting
Harbin, Heilong jiang, China, 150081
Contact: Bo Yu, MD, PhD 86-0451-86605180 yubodr@163.com
Principal Investigator: Bo Yu, MD.PhD

Sponsors and Collaborators

Harbin Medical University

Investigators

Principal Investigator:	Bo Yu, MD, PhD	The Second Affiliated Hospital of Harbin Medical University

More Information

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Responsible Party:	Bo Yu, Department of Cardiology of The Second Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier:	NCT01021930 History of Changes
Other Study ID Numbers:	HMUOCT-DM vs NDM-1
First Posted:	December 1, 2009
Last Update Posted:	May 26, 2010
Last Verified:	December 2009

Keywords provided by Harbin Medical University:

Optical coherence tomography; Drug eluting stent; Coronary heart disease; Diabetes mellitus

Additional relevant MeSH terms:

Diabetes Mellitus; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Paclitaxel; Sirolimus	Everolimus; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs