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

Not Applicable

• Conditions: Ischemic Heart Disease; Coronary Artery Disease
• Interventions: Procedure: QFR-guided CABG; Procedure: Angio-guided CABG

• Registration Number: NCT03770520
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Last Update Submitted: 2018-12-09
• Study First Posted: 2018-12-10
• Last Update Posted: 2018-12-11
• Primary Completion: 2020-01-01
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QFR-guided	QFR-guided CABG	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.
Angio-guided	Angio-guided CABG	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.

Primary Outcome Measures

Name	Time	Method
The rate of graft patency	12 months	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

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event(MACE)	12 months	The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization
The rate of angina relief	12 months	whether angina is relieved will be evaluated

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China