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

Capital Medical University

Status: Unknown

Conditions: Ischemic Heart Disease; Coronary Artery Disease

Treatments: Procedure: QFR-guided CABG; Procedure: Angio-guided CABG

Study type: Interventional

Funder types: Other

Identifiers

NCT03770520

Z171100001017059

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

QFR-guided

Experimental group

Description:

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.

Treatment:

Procedure: QFR-guided CABG

Angio-guided

Active Comparator group

Description:

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.

Treatment:

Procedure: Angio-guided CABG