Impact of Preoperative Quantitative Flow Ratio on Radial Artery Graft Outcome After Coronary Artery Bypass Grafting in the ASRAB-Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- 6-month radial artery graft failure
研究概览
简要总结
In coronary artery bypass grafting (CABG), the use of radial artery (RA) is recommended by the guidelines only to significantly stenosed vessel, due to its high vulnerability to competitive flow. Fractional flow reserve (FFR) is the gold standard to measure physiological significance of coronary lesions and the potential for competitive flow. This study aims to investigate whether the preoperative quantitative flow ratio (QFR) measurement, a novel coronary angiography-based FFR, is associated with RA graft failure post-CABG, and to explore the best cut-off value of QFR for RA grafts using.
Patients from ASRAB-pilot trial (NCT04310995) undergoing primary isolated CABG using RA grafts, and with preoperative coronary angiography (CAG) images available for QFR analysis will be enrolled in this prospective double-blind observational study. QFR analysis will be conducted for all RA-grafted vessels based on preoperative CAG. The primary outcome will RA graft failure (FitzGibbon Grade B,O or S) evaluated by coronary computer tomography angiography or CAG at 7 days and 6 months post-CABG.
详细描述
Introduction:
The radial artery (RA) was first used by Carpentier for coronary artery bypass grafting (CABG) in 1971 because of a number of potential advantages, including ease of harvesting, a low propensity for wound infection, a larger diameter than other arterial grafts, and a thick, muscular wall that facilitates the construction of an anastomosis. However, early experience suggested that RA grafts were prone to spasm and functional occlusion, and their use was abandoned for many years. In the past decades, the advent of drug therapy to prevent graft spasm and the adoption of newer harvesting techniques revitalized the interest the use of radial artery. Recently several randomized trials has been conducted to prove the better graft patency over the saphenous vein (SV) and survival benefit was also observed as well. However, due to its unneglectable vulnerability to competitive flow, the recent American and European guidelines for coronary revascularization both limited the use of RA only in significantly stenosed vessels.
Fractional flow reserve (FFR) is the current gold standard to measure the physiological significance of coronary stenosis and the potential for competitive flow. The quantitative flow ratio (QFR) is a novel, intelligent, noninvasive method that enables efficient computation of the FFR from coronary angiography in good concordance with catheter-based FFR. QFR-guided percutaneous coronary intervention (PCI) has been used and showed the improved clinical outcomes in FAVOR III China trial (Comparison of Quantitative Flow Ratio-Guided and Angiography-Guided Percutaneous InterVention in Patients With cORonary Artery Disease).
The Impact of Preoperative Quantitative Flow Ratio on Radial-Artery Graft Outcome after Coronary Artery Bypass Grafting (ASRAB-QUARGO) study aims to investigate whether the preoperative QFR measurement is associated with RA graft patency 6 months after CABG, and to explore the best QFR cut-off value for guiding RA-CABG.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients enrolled in the ASRAB-pilot study.
排除标准
- •Preoperative CAG not available for QFR analysis.
- •The inclusion and exclusion criteria of ASRAB-pilot study are attached:
- •Inclusion Criteria:
- •Age≥18 years.
- •Male or female patients.
- •Have signed informed consent.
- •Have successfully accepted the first RA-CABG surgery.
- •Exclusion Criteria:
- •Previously experienced an allergy to active ingredients and/or excipients of experimental drugs.
- •Hypotension (defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg) after surgery.
- •Acute myocardial infarction, pulmonary congestion or cardiogenic shock after surgery.
- •Concomitant medications with phosphodiesterase-5 inhibitors such as sildenafil, vardenafil, tadalafil, etc.
- •Pathological sinus node syndrome, degree II or III atrioventricular block without cardiac pacemaker.
- •Contraindications for coronary computed tomography angiography (CCTA) or coronary arteriography (CAG) examination, such as iodine allergy, etc. (note: patients with renal insufficiency or even end-stage renal disease whose hemodialysis can be tolerated by CCTA or CAG tests are eligible for inclusion).
- •History or evidence of ongoing alcohol or drug abuse.
- •Life expectancy < 1 year judged by investigators.
- •Other inappropriate situations judged by investigators.
结局指标
主要结局
6-month radial artery graft failure
时间窗: 6 months after surgery
Graft outcome will be evaluated by CCTA or CAG according to the Fitzgibbon classification criteria: Grade A, grade B, grade O and grade S (String Sign). Grade B, O and S are considered as graft failure.
7-day radial artery graft failure
时间窗: 7 days after surgery
Graft outcome will be evaluated by CCTA or CAG according to the Fitzgibbon classification criteria: Grade A, grade B, grade O and grade S (String Sign). Grade B, O and S are considered as graft failure.
次要结局
- Unplanned coronary revascularization related to radial artery graft failure(within 6 months after surgery)
- Myocardial infarction related to radial artery graft failure(within 6 months after surgery)
- Major adverse cardiovascular event (MACE)(within 6 months after surgery)
研究者
Qiang Zhao,MD
Professor and director, Department of Cardiac Surgery,Vice President of Ruijin Hospital
Ruijin Hospital