distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
研究概览
简要总结
The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (cTRA) in patients undergoing coronary procedures. This prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dTRA.
详细描述
Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and elective coronary procedures. The advantages of TRA compared to the transfemoral access encompass a reduction of mortality, complications, and cost as well as improvement of patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial Access for coRonary procEdures Study) was to assess the feasibility, safety and various ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial. There are two arms: distal transradial access and conventional transradial approach.
400 patients were enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •patients referred for CAG and/or PCI
排除标准
- •ST-elevation myocardial infarction
- •sudden cardiac arrest
- •hemody-namic instability
- •chronic kidney disease (stages 4-5)
- •forearm artery occlusion
- •previous unsuccessful ipsilateral TRA
- •unfavorable RA diameter
- •ultrasound unavailability
结局指标
主要结局
The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
时间窗: up to 24 hours
Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one. Access-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm). MACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death.
次要结局
- efficacy endpoint: duration of access performance(during the procedure index)
- efficacy endpoint: rate of access crossover(during the procedure index)
- safety endpoint: access-site vascular complications(after 24 hours post procedure)
- safety endpoint: patients' discomfort evaluated during access performance(during the procedure)
研究者
Łukasz Koziński
Principal Investigator Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński
Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński