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| Name | Class |
|---|---|
| Med-X Research Institute, Shanghai Jiao Tong University | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QFR group | Experimental |
| |
| CAG group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QFR-guided strategy | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year | 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 | within 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The number of grafts per person | counted as distal anastomosis | at Day 0 |
| The total circulatory time during the surgery | minutes | at Day 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiang Zhao, MD. | Ruijin Hospital | Principal Investigator |
| Shengxian Tu, PhD. | Med-X Research Institute, Shanghai Jiao Tong University | Principal Investigator |
| Yunpeng Zhu, MD. | Ruijin Hospital | Study Director |
| Mario Gaudino, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| Fujian Medical University Union Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41864747 | Derived | Zhu Y, Cheng Z, Zhao Y, Han L, Zhang W, Zhang C, Yang S, Ma L, Qiao C, Guo Z, Zhu D, Zhang X, Chen L, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Zhu J, Xu Z, Qin G, Wijns W, Redfors B, Sandner S, Gaudino M, Tu S, Zhao Q. Angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in China (FAVOR IV-QVAS): a multicentre, triple-blind, randomised trial. Lancet. 2026 Mar 21;407(10534):1161-1170. doi: 10.1016/S0140-6736(25)02418-3. | |
| 39534354 |
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| CAG-guided strategy | Other | 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. |
|
| 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 | 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 | within 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 |
| Health-related quality of life | the variables are the EQ-5D scores | within 30 days, 1 year and 3 years after surgery |
| Cost effectiveness | 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 | within 30 days, 1 year and 3 years after surgery |
| The total cross-clamp time during the surgery | minutes | at Day 0 |
| 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 |
| Change from baseline in the New York Heart Association (NYHA) score (1-4) | at 1 year after surgery |
| Change from baseline in the NYHA score (1-4) | at 3 years after surgery |
| Fuzhou |
| Fujian |
| China |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| The Second XiangYa Hospital of Central South University | Changsha | Hunan | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | China |
| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Changhai Hospital of Shanghai | Shanghai | Shanghai Municipality | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Derived |
| Zhu J, Zhu Y, Zhang W, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Kang L, Tu S, Zhao Q. Preliminary outcomes of quantitative flow ratio-guided coronary bypass grafting in primary valve surgery: A propensity score weighted analysis. JTCVS Open. 2024 Jun 25;21:90-108. doi: 10.1016/j.xjon.2024.06.008. eCollection 2024 Oct. |