Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long term clinical impact of routine follow-up coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous coronary intervention.

Detailed Description
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Routine follow-up coronary angiography after percutaneous coronary intervention has been performed to detect restenosis in a lot of PCI centers in Japan. On the other hand, previous studies reported that routine follow-up coronary angiography might lead to unnecessary reinterventions in asymptomatic patients. In this situation, the effect of routine follow-up coronary angiography on long-term clinical outcomes remains unknown. The purpose of this study is to evaluate the long-term clinical impact of routine follow-up coronary angiography after PCI compared with clinical follow-up alone. The primary endpoint of this study is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at three-year after percutaneous coronary intervention. The design of this study is almost all-comer design enrolling patients received PCI without any exclusion criteria.

Official Title
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Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: follow-up coronary angiography
* Procedure: Clinical follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients received percutaneous coronary intervention Patients older than 20 years old Patients who will not scheduled any staged percutaneous coronary intervention

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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: routine follow-up coronary angiography<br>routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention | Procedure: follow-up coronary angiography<br>* follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention<br>|
| Active Comparator: clinical follow-up<br>no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention | Procedure: Clinical follow-up<br>* no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure | a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure | 4.8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | death | 4.8 years | 
| cardiac death | cardiac death | 4.8 years | 
| myocardial infarction | myocardial infarction | 4.8 years | 
| stent thrombosis | stent thrombosis defined bya Academic Reseach Consortium | 4.8 years | 
| stroke | both ischemic and hemorrhagic stroke excluding transient ischemic attach | 4.8 years | 
| bleeding complications | bleeding complications defined by GUSTO and TIMI | 4.8 years | 
| any coronary revascularization | any coronary revascularization | 4.8 years | 
| clinically-driven coronary revascularization | clinically-driven coronary revascularization | 4.8 years | 
| clinically-driven target-lesion revascularization | clinically-driven target-lesion revascularization | 4.8 years | 
| any target-lesion revascularization | any target-lesion revascularization | 4.8 years | 
| coronary artery bypass grafting | coronary artery bypass grafting | 4.8 years | 
| angina | angina | 4.8 years | 
| renal function | estimate-glomerular filtration rate | 4.8 years | 
| emergency hospitalization for acute coronary syndrome | emergency hospitalization for acute coronary syndrome | 4.8 years | 
| hospitalization for congestive heart failure | hospitalization for congestive heart failure | 4.8 years | 
| composite of cardiac death, myocardial infarction or acute coronary syndrome | composite of cardiac death, myocardial infarction or acute coronary syndrome | 4.8 years | 
| follow-up coronary angiography | presence of follow-up coronary angiography | 4.8 years | 
| clinically-driven follow-up coronary angiography | presence of clinically-driven follow-up coronary angiography | 4.8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow-up coronary angiography