Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients

Study Overview
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Brief Summary
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Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.

Official Title
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Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients (The REVISE Trial)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Routine Angiography Follow-up
* Diagnostic Test: Routine Clinical Follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Successful PCI with at least two of the following high-risk factors: A. Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease (defined as an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); L. Myocardial infarction; - He/she or his/her legally authorized representative provides written informed Exclusion Criteria: Revascularization with bare metal stents and/or balloon angioplasty with non-drug-coated balloons. Pregnant and/or lactating women. Life expectancy of less than 2 years. Repeat interventional therapy is planned. Subject was unable to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine Angiography Follow-up (RAF) group<br>Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization. | Diagnostic Test: Routine Angiography Follow-up<br>* Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.<br>|
| Active Comparator: Routine Clinical Follow-up (RCF) group<br>Patients in the RCF group will have routine clinical follow-up at 12 months after revascularization, and the physician will decide whether further invasive testing is needed. | Diagnostic Test: Routine Clinical Follow-up<br>* Patients in the RCF group will have routine clinical follow-up at 12 months after revascularization, and the physician will decide whether further invasive testing is needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | 60 months | 
| All-cause death | The rate of all-cause death | 24 and 60 months | 
| Myocardial infarction | The rate of myocardial infarction | 24 and 60 months | 
| Hospitalization for unstable angina | The rate of hospitalization for unstable angina | 24 and 60 months | 
| Cardiac death | The rate of hospitalization for cardiac death | 24 and 60 months | 
| Invasive angiography during follow-up | The rate of invasive angiography during follow-up | 24 and 60 months | 
| Any revascularization | The rate of any revascularization during follow-up (ischemia-driven vs. all-cause) | 24 and 60 months | 
| Revascularization of any target vessel/lesion | The rate of revascularization of any target vessel/lesion | 24 and 60 months | 
| Revascularization of any non-target vessel/lesion | The rate of revascularization of any non-target vessel/lesion | 24 and 60 months | 
| Health Economics Analysis (cost-effectiveness) |  | 24 and 60 months |