Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,350
- 试验地点
- 10
- 主要终点
- Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery.
研究概览
简要总结
Internal thoracic arteries can be harvested in skeletonized or pedicled technique. Latest research has posed a potential adverse effect of skeletonizing the internal thoracic arteries on graft patency rates and clinical outcome. Prospective, randomized, multi-centre trials are necessary to investigate the impact of harvesting technique of left internal thoracic artery (LITA) on graft patency rates and clinical outcome after coronary artery bypass grafting.
The HARVITA trial compares skeletonized and pedicled harvesting technique of LITA regarding graft patency rates and patient survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary isolated CABG patients with multi-vessel disease (defined as ≥70 % stenosis of the left anterior descending artery (LAD) and ≥50% stenosis of circumflex and right coronary territory, with or without a ≥50% stenosis of the left main artery).
排除标准
- •Age > 80 years
- •Planned CABG without LITA use
- •Preoperative mediastinal radiation therapy
- •Emergency operation
- •Minimal invasive coronary artery bypass surgery
- •Any concomitant cardiac or non-cardiac procedures
- •Previous cardiac surgery
- •Known contrast agent allergy
- •Severe stenosis of the left subclavian artery/ left-sided subclavian steal syndrome
- •Chronic kidney disease (GFR <60ml/min/1.73m²)
- •Life expectancy of less than 5 years
- •Pregnancy
- •Hyperthyroidism
- •Iodine allergy
- •Intraoperative exclusion criteria:
- •Y/T graft off the LITA graft
- •LITA sequential grafting
- •LITA target vessel other than LAD
研究组 & 干预措施
skeletonized harvesting technique
In skeletonized harvesting technique, only the left internal artery itself is harvested.
干预措施: skeletonized harvesting technique (Procedure)
pedicled harvesting technique
In pedicled harvesting technique the left internal thoracic artery, it's accompanying veins and parts of the endothoracic fascia is harvested, creating a 1-2 cm broad pedicle.
干预措施: pedicled harvesting technique (Procedure)
结局指标
主要结局
Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery.
时间窗: 2 years (+/- 3 months) after surgery
The primary endpoint will be compared between the two treatment groups using Kaplan-Meier graphs and a center stratified two sample log-rank test. In addition, Cox proportional hazards regression analysis adjusting for clinically relevant confounders will be performed. Hazard ratios and their 95% confidence intervals will be estimated. LITA graft occlusion is defined as the absence of contrast detection in the lumen of the graft indicating a 100% occlusion of LITA graft.
次要结局
- composite outcome of all-cause death, myocardial infarction and repeated revascularization(1 year, 2 years and 5 years after surgery)