Surgical and Pharmacological Novel Interventions to Improve Overall Results of Saphenous Vein Graft Patency in Coronary Artery Bypass Grafting Surgery: An International Multi-Center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups.
研究概览
简要总结
Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be accomplished using veins from the leg sewn onto the heart to provide an alternate path for blood flow, i.e. 'bypassing' the blockages. These veins themselves can block over time. This may result in part simply from the trauma from the surgery, in other words, by removing the vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal metabolic processes within the body responsible for the plaque build-up of the heart arteries in the first place - this may lead to the blockages of the veins used for bypass. In the present era of heart bypass surgery, this incidence of veins blocking remains high despite advances in blood thinners and cholesterol medications. This study is designed to determine whether two new interventions may potentially reduce the incidence of blockages in the veins used for heart bypass surgery. One is a surgical technique significantly reducing the trauma associated with removing the leg vein prior to use as a bypass graft onto the heart. The second intervention is the use of a nutritional supplement before and after surgery which is composed of fish oils. The study will recruit sufficient patients to provide strong and relevant conclusions regarding both study questions. It will be highly applicable also because it will include approximately 1,550 patients from approximately 50 hospitals across many countries. We believe these techniques will result in significantly less vein blockages in patients one year after heart bypass surgery.
详细描述
Background: Saphenous vein grafts (SVG) remain the most widely used conduit for CABG. However, contemporary patency rates at one-year post CABG remain poor, despite optimal medical therapy. Recent trials (PREVENT IV) demonstrate that up to 45% of all patients have one or more SVG occluded at angiography one year post-CABG; up to 25% of all SVG are occluded at one year post-CABG angiography. Furthermore, patients with at least one SVG occluded had twice the incidence of perioperative MI, and thirteen times the composite endpoint of death, late MI or repeat revascularization at 12-18 months.
The proposed SUPERIOR SVG Trial is a prospective, international, multi-centre randomized controlled clinical trial (RCT). It utilizes a factorial design to elucidate the benefits of two interventions, one surgical and the other pharmacological, to improve saphenous vein graft patency after coronary artery bypass grafting surgery (CABG):
Surgical Arm: Does a novel atraumatic ("no touch") technique of pedicled saphenous vein graft (SVG) harvesting result in improved angiographic patency and clinical outcomes at 1 year, compared to conventional SVG harvesting techniques, in patients undergoing CABG.
Rationale: A Swedish cardiac surgical centre has published numerous studies demonstrating that harvesting the SVG with a cushion of surrounding fat and without vein graft distension, "no touch" technique, improved surrogate markers of vein preservation in operative specimens. Graft patency was superior in a single small RCT (8.5 year patency: "no touch" 90% vs. conventional 76%, p=0.01, adjusted OR 3.7, 95% CI 1.4-9.6, p=0.007).
Pharmacological Arm: Does N-3 polyunsaturated fatty acid (fish oil) oral supplementation result in improved angiographic patency and clinical outcomes at 1 year, compared to placebo, in patients undergoing CABG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 years
- •Able to provide informed consent
- •Isolated CABG, non-emergent, on- or off-pump (cardiopulmonary bypass)
- •Primary or re-do CABG (if re-do, all previous grafts must be occluded)
- •Left ventricular ejection fraction >20%
- •Require at least one SVG as part of revascularization strategy
- •Creatinine clearance of at least 30ml/min or higher
排除标准
- •Unable to use greater SV due to previous vein stripping or poor quality on mandatory preoperative Duplex study and vein mapping
- •Contraindication to receiving follow-up 64-slice cardiac CT angiography (allergy to contrast dye, renal failure with a creatinine >180 µmol/L, uncontrolled atrial fibrillation precluding proper gating of study)
- •Pregnant women, or women of child-bearing age
- •Allergy to fish oil/fish products, and non-medicinal ingredients of the study product (corn oil,soybean oil,gelatin,glycerol, or carob colouring)
- •Already taking fish oil supplements regularly (daily use in past 30 days)
- •Congenital or acquired coagulation disorders
- •Patients considered to be of excessive risk of wound infection according to the clinical judgement of the site surgical investigator.
研究组 & 干预措施
SVG harvest - no-touch, placebo
干预措施: No-touch SVG harvest vs conventional SVG harvest technique (Procedure)
SVG harvest - no-touch, placebo
干预措施: Fish oil supplementation vs placebo (Dietary Supplement)
SVG harvest - conventional, fish oils
干预措施: No-touch SVG harvest vs conventional SVG harvest technique (Procedure)
SVG harvest - conventional, fish oils
干预措施: Fish oil supplementation vs placebo (Dietary Supplement)
SVG harvest - conventional, placebo
干预措施: No-touch SVG harvest vs conventional SVG harvest technique (Procedure)
SVG harvest - conventional, placebo
干预措施: Fish oil supplementation vs placebo (Dietary Supplement)
SVG harvest - no-touch, fish oils
干预措施: No-touch SVG harvest vs conventional SVG harvest technique (Procedure)
SVG harvest - no-touch, fish oils
干预措施: Fish oil supplementation vs placebo (Dietary Supplement)
结局指标
主要结局
Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups.
时间窗: 1-year post-operative
Surgical Arm: Proportion of study SVGs which are totally occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes.
时间窗: 1 year post-operative
次要结局
- Surgical Arm: ii. To determine whether the incidence and severity of adverse SVG harvesting events at 1-yr post-CABG (infection, haematoma, swelling, neuropathy, quality of life measures) are similar between the "no touch" and conventional groups.(1-year post-operative)
- Surgical Arm: iii. The incidence of the composite of non-fatal MI (new definition), all-cause mortality, and repeat revascularization (redo CABG or PCI) perioperatively ( major adverse cardiac events ,MACE ) and stroke at 1 yr is lowe(1-year post-operative)
- Pharmacological Arm: ii. The incidence of the composite of n-fatal MI (new definition), all-cause mortality, and repeat revascularization (redo CABG or PCI) perioperatively ( major adverse cardiac events ,MACE ) and stroke at 1 yr i(1-year post-operative)
- Surgical Arm: i. To determine whether the "no touch" technique of SVG harvesting results in a lower proportion of study SVGs that have a significant stenosis (50-99%) on 1-year post-CABG angiography compared to conventional SVG harvesting techniques.(1 year post-operavtive)
- Pharmacological Arm: i. To determine whether fish oil supplementation results in a lower proportion of patients with ≥1 graft with a significant (50-99%) stenosis at 1-year post-CABG angiography, compared to those who received placebo.(1-year post-operative)
研究者
Stephen E. Fremes
Head, Division of Cardiac & Vascular Surgery
Sunnybrook Health Sciences Centre