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 Versus Biolimus A9-eluting Stents

Study Overview
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Brief Summary
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This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion . The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography. After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.

Detailed Description
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This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry. However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible. Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress. To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.

Official Title
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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 Versus Biolimus A9-eluting Stents: Retrospective and Prospective Follow-up Study for Patients Who Were Enrolled in the Previous DETECT-OCT Study

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. patients who were enrolled in the previous DETECT-OCT study 2. Patients who agreed with informed consents Exclusion Criteria: 1. Patients who disagreed with informed consents

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCT-guided group<br>OCT-guided PCI with EES or BES | |
| Angiography-guidance group<br>Angio-guided PCI with EES or BES | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Free from death | At 5 years | 
| Overall survival | Free from death | At 10 years | 
| Cardiac death | Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee. | At 5 years | 
| Cardiac death | Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee. | At 10 years | 
| Myocardial infarction | (Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI) | At 5 years | 
| Myocardial infarction | (Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI) | At 10 years | 
| Target lesion revascularization | Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent. | At 5 years | 
| Target lesion revascularization | Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent. | At 10 years | 
| Target vessel revascularization | Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel. | At 5 years | 
| Target vessel revascularization | Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel. | At 10 years | 
| Stent thrombosis | Based on the Academic Research Consortium (ARC) definition. Definitive stent thrombosis Probable stent thrombosis Possible stent thrombosis | At 5 years | 
| Stent thrombosis | Based on the Academic Research Consortium (ARC) definition. Definitive stent thrombosis Probable stent thrombosis Possible stent thrombosis | At 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual antiplatelet therapy duration, Optical coherence tomography