Clinical trial NCT03977129: Quantitative Flow Ratio (QFR) Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease
Official title: A Multicenter, Prospective, Randomized, Blind, Controlled Clinical Study to Compare the Efficacy of Quantitative Flow Ratio Guided and Coronary Angiography Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Valvular Heart Disease With Comorbid Coronary Artery Disease
Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Med-X Research Institute, Shanghai Jiao Tong University
First posted: 2019-06-06
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective, randomized, blinded, controlled clinical study in patients with planned primary valvular surgery and comorbid coronary artery lesions with diameter stenosis of ≥ 50%, to compare the effectiveness of an Quantitative Flow Ratio (QFR)-guided revascularization strategy and a coronary angiography (CAG)-guided revascularization strategy in preventing the incidence of composite outcome (MACE-5, including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis) within 30 days after surgery. The study hypothesis is that the QFR-guided strategy can reduce the incidence of the MACE-5 within 30 days after surgery, as compared with the CAG-guided strategy.

Detailed description: It is planned to enroll 792 subjects aged ≥18 years, with no gender restriction, who plan to undergo elective open-heart valvular surgery due to primary valvular heart disease, with comorbid coronary artery lesions defined as diameter stenosis of ≥ 50% (visual estimation) that are diagnosed by CAG before the surgery.

QFR group: Calculate the QFR values of all target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR \> 0.80, then no CABG revascularization of target blood vessels will be carried out.

CAG group (control group): All target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization will undergo simultaneous CABG revascularization.

Intervention duration: The assessments will be performed after randomization and before the surgery to guide the surgery.

No planned interim analysis.

Eligibility criteria: Inclusion Criteria:

* Voluntarily participate in the trial and provide the informed consent form;
* Male or female patients aged ≥ 18 years;
* Planned to undergo elective on-pump valve surgery due to primary mitral and/or aortic valvular heart disease (such as rheumatic, degenerative, infective, congenital valvular heart disease, etc.);
* At least one target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with preoperative diameter stenosis of ≥ 50% by coronary angiography (visual estimation, subject to written coronary angiography report) and suited for CABG revascularization.

Exclusion Criteria:

* History of heart surgery;
* Planned second-stage PCI or CABG revascularization;
* Secondary valvular heart disease (ischemia, cardiomyopathy);
* Planned valve intervention surgery through the catheter;
* Subjects that were evaluated to have cardiogenic shock or other critical conditions that were not appropriate for the trial by study physician;
* QFR calculations cannot be carried out from preoperative coronary angiography data (such as poor projection position, inability to detect vascular boundaries, poor contrast agent filling, excessive overlap or severely distorted of vessel lesion sections, lesion involved in myocardial bridge, or lesion site within 3 mm from the ostium of the main coronary artery);
* The target coronary arteries were evaluated to be not suitable for CABG by study physician;
* Life expectancy \< 3 years.

Primary outcomes:
measure: The 30-day incidence of composite outcome (MACE-5) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year
timeFrame: within 1 year after surgery
measure: The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
timeFrame: at 1 year after surgery
measure: The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 year
timeFrame: within 3 years after surgery
measure: The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
timeFrame: at 3 years after surgery
measure: Health-related quality of life
timeFrame: within 30 days, 1 year and 3 years after surgery
measure: Cost effectiveness
timeFrame: within 30 days, 1 year and 3 years after surgery
Other outcomes:
measure: The number of grafts per person
timeFrame: at Day 0
measure: The total circulatory time during the surgery
timeFrame: at Day 0
measure: The total cross-clamp time during the surgery
timeFrame: at Day 0
measure: The total units of erythrocyte transfusion during and after the surgery till discharge
timeFrame: from Day 0 to discharge day
measure: The number of days from surgery day to discharge day
timeFrame: from Day 0 to discharge day
measure: Change from baseline in the Canadian Cardiac Society (CCS) anginal status score (0-4)
timeFrame: at 1 year after surgery
measure: Change from baseline in the CCS anginal status score (0-4)
timeFrame: at 3 years after surgery
measure: Change from baseline in the New York Heart Association (NYHA) score (1-4)
timeFrame: at 1 year after surgery
measure: Change from baseline in the NYHA score (1-4)
timeFrame: at 3 years after surgery
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: The Second XiangYa Hospital of Central South University
state: Hunan
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Ruijin Hospital
name: Qiang Zhao, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Med-X Research Institute, Shanghai Jiao Tong University
name: Shengxian Tu, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Yunpeng Zhu, MD.
role: STUDY_DIRECTOR
References: