DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES) (DETECT-OCT)

Yonsei University

Status: Completed

Conditions: Ischemic Heart Disease

Treatments: Device: Angio-guided PCI with EES or BES; Device: PCI with EES under angio-guide or OCT guide; Drug: Keep DAPT; Device: OCT-guided PCI with EES or BES; Device: PCI with BES under angio-guide or OCT guide; Drug: Discontinue DAPT

Study type: Interventional

Funder types: Other

Identifiers

NCT01752894

1-2012-0047

Details and patient eligibility

About

The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES vs BES implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months

Enrollment: 776 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 20 years old
• Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation.
• Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm
• Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion criteria

• Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
• Reference vessel diameter < 2.5 mm or > 4.0mm
• Heavy calcified lesions (definite calcified lesions on angiogram)
• Primary PCI for STEMI
• Contraindication to anti-platelet agents
• Treated with any DES within 3 months at other vessel
• Creatinine level ≥ 2.0 mg/dL or ESRD
• Severe hepatic dysfunction (3 times normal reference values)
• Pregnant women or women with potential childbearing
• Life expectancy < 1 year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

776 participants in 6 patient groups

Angio guided PCI

Active Comparator group

Treatment:

Device: Angio-guided PCI with EES or BES

OCT-guided PCI

Experimental group

Treatment:

Device: OCT-guided PCI with EES or BES

BES

Active Comparator group

Treatment:

Device: PCI with BES under angio-guide or OCT guide

EES

Experimental group

Treatment:

Device: PCI with EES under angio-guide or OCT guide

Keep dual antiplatelet therapy (DAPT)

Active Comparator group

Description:

Study subjects will be allocated into this arm with non-randomization method

Treatment:

Drug: Keep DAPT

Discontinue Dual antiplatelet therapy (DAPT)

Active Comparator group

Description:

Study subjects will be allocated into this arm with non-randomization method

Treatment:

Drug: Discontinue DAPT