Real-time Feedback of SYNTAX Score Category During Coronary Angiographies to Improve Appropriateness of Coronary Revascularization for Patients With Stable Coronary Artery Diseases: a Before-and-after Controlled Study

Study Overview
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Brief Summary
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The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (CR) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (CAD). However, discrepancy in SS between angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in patients with stable CAD remain unknown. Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the angiographies will improve CR appropriateness. A before-and-after controlled trial was designed. In the first period of time, stable CAD patients undergoing elective coronary angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac center will be continuously recruited as the control group. In the second period, eligible patients will be recruited continuously and a real-time SS category feedback from ACL rightafter the angiography will be given to the cardiologists. Appropriateness of treatment strategies in two groups will be analyzed to determine whether a real-time SS feedback can improve the treatment appropriateness. The appropriateness of treatment strategies will be adjudicated by Chinese version appropriate use criteria for CR.

Conditions
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Syntax Score, Appropriateness, Coronary Revascularization

Intervention / Treatment
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* Diagnostic Test: real-time feedback of SYNTAX score category


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%; Patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom); Written informed consent. Exclusion Criteria: Have prior CABG; Have stage PCI; Have no assigned scenario in Chinese appropriate use criteria.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYNTAX score category feedback group<br>A real-time SYNTAX score category feedback from angiographic core lab will be given to the cardiologists rightafter the angiographies. | Diagnostic Test: real-time feedback of SYNTAX score category<br> <br> |
| No Intervention: Controlled group<br>Cardiologists' subjective SYNTAX score category judgement will be recorded during the angiography. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inappropriate rate of coronary revascularization | Inappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization. | 1 month after study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of inappropriate PCI | Inappropriate rate of percutaneous coronary intervention (PCI) will be adjudicated by Chinese appropriate use criteria for coronary revascularization. | 1 month after study completion | 
| The proportion of inappropriate CABG | Inappropriate rate of coronary artery bypass graft (CABG) will be adjudicated by Chinese appropriate use criteria for coronary revascularization. | 1 month after study completion | 
| The proportion of utilizing PCI procedures | The proportion of patients who undergo percutaneous coronary intervention (PCI) among total patients | 1 month after study completion | 
| The proportion of utilizing CABG procedures | The proportion of patients who undergo coronary artery bypass graft (CABG) among total patients | 1 month after study completion |