Safety and Efficacy Study of Endothelial Progenitor Cell Capture Stent With 1 Months Dual Antiplatelet Therapy

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Thanks to rapid reendothelialization derived from the pro-healing property of the EPC capture stent, 1-month dual antiplatelet therapy (DAPT) is recommended after EPC capture stent implantation. Shorter maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent wasteful medications and bleeding complications related with dual antiplatelet therapy. Thus, the EPC capture stent might be valuable for the elderly because they are vulnerable to premature discontinuation of DAPT.

On the other hand, statin upstream therapy has gained popularity because it seems to reduce periprocedural myocardial injury especially in ACS through its pleiotrophic effect like plaque stabilization. However, the benefit of pretreatment of statin in patients with stable angina remains controversial. It is reported that statin administration could increase EPC level by accelerated differentiation towards the endothelial progenitor lineage.

We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is non-inferior to DES in the elderly subjects with stable coronary artery disease. To test this hypothesis, we will perform a multi-center, randomized, prospective trial aimed at demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in real world practice.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Collaborators: OrbusNeich; Yuhan Corporation
• Treatments: Atorvastatin; Atorvastatin Calcium; Clopidogrel; Everolimus; Sirolimus; Ticlopidine

Criteria

Inclusion Criteria:

• Age ≥70 years patients with coronary artery disease (≤stable angina CCS III, Unstable angina IIb

• patients with signed informed consent

• significant coronary artery stenosis (>50%) considered for coronary stenting

• Reference vessel diameter of 2.5 to 4.0 mm

Exclusion Criteria:

• The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Everolimus, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)

• Systemic (intravenous) Everolimus use within 12 months

• The patients who are receiving anticoagulants or anti-platelet medications besides aspirin & clopidogrel

• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions

• Baseline hemogram with Hb<10g/dL or PLT count <100,000/μL

• Severe Hepatic dysfunction (≥ 3 times normal reference values)

• Significant renal dysfunction (Serum creatinine ≥ 2.0 mg/dl)

• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months

• Patients with LV systolic dysfunction (LVEF<40%) or in cardiogenic shock

• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

• An elective surgical procedure is planned that would necessitate interruption of DAPT during the first 12 months post enrollment