Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease, Primary Valvular Heart Disease With Comorbid Coronary Artery Disease
Conditions
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.
Interventions
DEVICEQFR-guided strategy
In this study, the QFR-guided strategy will be applied to in the QFR group in which calculation of the QFR values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to CABG revascularization will be carried out. 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.
OTHERCAG-guided strategy
In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and suited for CABG revascularization will undergo CABG revascularization.
Sponsors
Med-X Research Institute, Shanghai Jiao Tong University
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | within 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis) | at 1 year after surgery | — |
| The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 year | within 3 years after surgery | The time from randomization to first occurrence of any of composite outcome (MACE-6) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris, and hospitalization or urgent visits for heart failure |
| The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year | within 1 year after surgery | The time from randomization to first occurrence of any of composite outcome (MACE-6) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris, and hospitalization or urgent visits for heart failure |
| Health-related quality of life | within 30 days, 1 year and 3 years after surgery | the variables are the EQ-5D scores |
| Cost effectiveness | within 30 days, 1 year and 3 years after surgery | the variables are the cost increased for each composite outcome reduction at 30 days after surgery and cost increased for each additional QALY at 1 year and 3 years after surgery |
| The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis) | at 3 years after surgery | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the New York Heart Association (NYHA) score (1-4) | at 1 year after surgery | — |
| The number of grafts per person | at Day 0 | counted as distal anastomosis |
| Change from baseline in the NYHA score (1-4) | at 3 years after surgery | — |
| The total circulatory time during the surgery | at Day 0 | minutes |
| The total cross-clamp time during the surgery | at Day 0 | minutes |
| The total units of erythrocyte transfusion during and after the surgery till discharge | from Day 0 to discharge day | — |
| The number of days from surgery day to discharge day | from Day 0 to discharge day | — |
| Change from baseline in the Canadian Cardiac Society (CCS) anginal status score (0-4) | at 1 year after surgery | — |
| Change from baseline in the CCS anginal status score (0-4) | at 3 years after surgery | — |
Countries
China
Outcome results
None listed