Clinical trial NCT01752894: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 776
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: percentage of neointimal coverage at 3 month-OCT after stent implantation
timeFrame: at 3 month-OCT after stent implantation
Secondary outcomes:
measure: The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months
timeFrame: 12 months after PCI
measure: percentage of malposition strut at 3 month-OCT after stent implantation
timeFrame: 3 months after PCI
measure: The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.
timeFrame: 12 months after PCI
measure: Target vessel revascularization
timeFrame: 12 months after PCI
measure: TIMI-defined major bleeding for 12 months
timeFrame: 12 months after PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: 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.
citation: 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.