COmparison of Xience PrimE Versus REsolute Integrity in Diabetes or Small Vessel Disease (COPERES)

Chonbuk National University

Status and phase: Unknown; Phase 3

Conditions: Angioplasty, Balloon, Coronary

Treatments: Procedure: percutaneous coronary intervention using drug eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01752127

The COPERES trial

Details and patient eligibility

About

The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years
2. Patients requiring stent procedure (visual diameter stenosis ≥ 50%)
3. Stable angina with evidence of myocardial ischemia, acute coronary syndrome(ST segment elevation, non-ST segment elevation acute myocardial infarction, and unstable angina)
4. Patients diagnosed of type 2 diabetes or small vessel disease
5. Patients willing to participate in the study through written consent

Exclusion criteria

1. Those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus.
2. Pregnant women or those having future plans for pregnancy.
3. Those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion.
4. Those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months.
5. Those with thrombocytopenia (< 100,000/mm3) or hemoglobin 10.0 g/dL or less.
6. Those planning a surgery that requires the discontinuation of antiplatelet drugs within next 12 months (especially, thienopyridines type).
7. When the remaining survival period is expected to be less than 1 year.
8. Restenosis lesion
9. Left main coronary artery lesion
10. Saphenous vein graft stenosis lesion
11. Left ventricular ejection fraction < 30%
12. Cardiac shock
13. Those with liver function failure: When liver enzyme level (ALT) is 3 times the normal upper limit.
14. Type I diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

DM arms

Active Comparator group

Description:

comparison of two different stents(Xience prime and Resolute integrity)

Treatment:

Procedure: percutaneous coronary intervention using drug eluting stent

Small vessel arms

Active Comparator group

Description:

comparison of two different stents(Xience prime and Resolute integrity)

Treatment:

Procedure: percutaneous coronary intervention using drug eluting stent