Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.

Detailed Description
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CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.

Official Title
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The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial

Conditions
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Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
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* Procedure: QFR-guided CABG
* Procedure: Angio-guided CABG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with evidence of angina pectoris left main or three vessels disease, have the indication for CABG after discussion of the heart team at least one main vessels stenosis on 40%-70% Exclusion Criteria: former cardiac surgery patients need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy emergent CABG acute myocardial infarction time less than 7 days life expectancy less than 3 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QFR-guided<br>This group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR. | Procedure: QFR-guided CABG<br>* CABG surgery based on CAG and QFR<br>|
| Active Comparator: Angio-guided<br>This group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team. | Procedure: Angio-guided CABG<br>* CABG surgery based on heart team discussion of CAG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of graft patency | graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular event(MACE) | The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization | 12 months | 
| The rate of angina relief | whether angina is relieved will be evaluated | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quantitative Flow Ratio, Coronary Artery Bypass Grafting, Graft patency