Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.

Official Title
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a Multi-center, Open-label, Nationwide Registry-based, Randomized, Pragmatic Trial Comparing 2 Post-PCI Management Strategies in High-risk PCI Patients With Complex Clinical and Lesion Characteristics

Conditions
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Coronary Artery Disease With Myocardial Infarction

Intervention / Treatment
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* Diagnostic Test: routine stress testing
* Diagnostic Test: No Routine stress testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject was > 19 years of age. Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion. Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors. 3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI). 3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (≥ 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length ≥30 mm or stent length ≥32 mm), or vein bypass graft stented The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: Cardiogenic shock at the index admission Subject treated with only bare metal stent or balloon angioplasty during the index procedure. Pregnant and/or lactating women. Concurrent medical condition with a life expectancy of less than 1 years Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 6 Subject was unable to provide written informed consent or participate in long-term follow-up.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Routine stress testing after PCI<br> | Diagnostic Test: No Routine stress testing<br>* In the group of symptom oriented stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed when chest pain or angina symptom is occured after the procedure according to the practice pattern of each participating center.<br>|
| Experimental: Routine stress testing at 9 15 months after PCI<br> | Diagnostic Test: routine stress testing<br>* In the group of routine stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed at 9 15 months after the procedure according to the practice pattern of each participating center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of major cardiovascular events | a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 2 year | 
| Myocardial infarction |  | 2 year | 
| Unstable angina hospitalization |  | 2 year | 
| Death or myocardial infarction |  | 2 year | 
| Any hospitalization | cardiac cause vs. noncardiac cause | 2 year | 
| Invasive catheterization |  | 2 year | 
| Repeat revascularization procedure | Repeat revascularization procedure during follow-up; target vs. non-target lesion (or vessel), ischemia-driven vs. not ischemia-driven. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, noninvasive stress testing, high risk, unstable angina