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)

NCT01752894 | Completed

• 1 other identifier: 1-2012-0047
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• percentage of neointimal coverage at 3 month-OCT after stent implantation

  at 3 month-OCT after stent implantation

Secondary Outcomes (5)

• The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months

  12 months after PCI

• percentage of malposition strut at 3 month-OCT after stent implantation

  3 months after PCI

• The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.

  12 months after PCI

• Target vessel revascularization

  12 months after PCI

• TIMI-defined major bleeding for 12 months

  12 months after PCI

Study Arms (6)

Angio guided PCI

ACTIVE COMPARATOR

Device: Angio-guided PCI with EES or BES

OCT-guided PCI

EXPERIMENTAL

Device: OCT-guided PCI with EES or BES

BES

ACTIVE COMPARATOR

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

EES

EXPERIMENTAL

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

Keep dual antiplatelet therapy (DAPT)

ACTIVE COMPARATOR

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

Drug: Keep DAPT

Discontinue Dual antiplatelet therapy (DAPT)

ACTIVE COMPARATOR

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

Drug: Discontinue DAPT

Interventions

Angio-guided PCI with EES or BES DEVICE

Angio-guided intervention

Angio guided PCI

OCT-guided PCI with EES or BES DEVICE

OCT-guided intervention

OCT-guided PCI

PCI with BES under angio-guide or OCT guide DEVICE

biolimus A9-eluting stent.

BES

PCI with EES under angio-guide or OCT guide DEVICE

everolimus eluting stent.

EES

Keep DAPT DRUG

maintain DAPT for 12 months according to level of uncovered strut (\>6%) at 3months OCT follow up after stent implantation.

Keep dual antiplatelet therapy (DAPT)

Discontinue DAPT DRUG

discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.

Discontinue Dual antiplatelet therapy (DAPT)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (3)

• Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Dec;55(12):1125-1137. doi: 10.4070/kcj.2025.0093. Epub 2025 Jul 14.

  PMID: 41044734 DERIVED

• Lee SY, Ahn CM, Yoon HJ, Hur SH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition. Circ Cardiovasc Interv. 2018 Dec;11(12):e007192. doi: 10.1161/CIRCINTERVENTIONS.118.007192.

  PMID: 30562088 DERIVED

• Lee SY, Kim JS, Yoon HJ, Hur SH, Lee SG, Kim JW, Hong YJ, Kim KS, Choi SY, Shin DH, Nam CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Strut Coverage in Patients Receiving Drug-Eluting Stents and its Implications for Dual Antiplatelet Therapy: A Randomized Trial. JACC Cardiovasc Imaging. 2018 Dec;11(12):1810-1819. doi: 10.1016/j.jcmg.2017.12.014. Epub 2018 Feb 14.

  PMID: 29454763 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 19, 2012
• Study Start: January 2, 2013
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: March 21, 2019

Record last verified: 2018-03

Locations

KR (1)