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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
700
follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, Japan
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
Time frame: 4.8 years
death
death
Time frame: 4.8 years
cardiac death
cardiac death
Time frame: 4.8 years
myocardial infarction
myocardial infarction
Time frame: 4.8 years
stent thrombosis
stent thrombosis defined bya Academic Reseach Consortium
Time frame: 4.8 years
stroke
both ischemic and hemorrhagic stroke excluding transient ischemic attach
Time frame: 4.8 years
bleeding complications
bleeding complications defined by GUSTO and TIMI
Time frame: 4.8 years
any coronary revascularization
any coronary revascularization
Time frame: 4.8 years
clinically-driven coronary revascularization
clinically-driven coronary revascularization
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Time frame: 4.8 years
clinically-driven target-lesion revascularization
clinically-driven target-lesion revascularization
Time frame: 4.8 years
any target-lesion revascularization
any target-lesion revascularization
Time frame: 4.8 years
coronary artery bypass grafting
coronary artery bypass grafting
Time frame: 4.8 years
angina
angina
Time frame: 4.8 years
renal function
estimate-glomerular filtration rate
Time frame: 4.8 years
emergency hospitalization for acute coronary syndrome
emergency hospitalization for acute coronary syndrome
Time frame: 4.8 years
hospitalization for congestive heart failure
hospitalization for congestive heart failure
Time frame: 4.8 years
composite of cardiac death, myocardial infarction or acute coronary syndrome
composite of cardiac death, myocardial infarction or acute coronary syndrome
Time frame: 4.8 years
follow-up coronary angiography
presence of follow-up coronary angiography
Time frame: 4.8 years
clinically-driven follow-up coronary angiography
presence of clinically-driven follow-up coronary angiography
Time frame: 4.8 years