A comparison of transradial versus transfemoral and standard versus ultrasound-guided approaches in reducing bleeding rates in patients undergoing coronary angiography or angioplasty.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,388
研究概览
简要总结
Abstract Aims: This study compared outcomes in unselected patients undergoing cardiac catheterization via transradial versus transfemoral access and standard versus ultrasound-guided arterial access. Methods and Results: A prospective, randomised (radial vs. femoral and standard vs. ultrasound), 2x2 factorial trial of 1388 patients undergoing coronary angiography and percutaneous coronary intervention. The primary outcome was a composite of ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) major bleeding, MACE (death, stroke, myocardial infarction or urgent target lesion revascularization) and vascular complications at 30 days. Transradial access reduced primary outcome when compared with transfemoral approach. There was no difference in the primary outcome between standard and ultrasound guidance. Ultrasound guidance however reduced mean access time, attempts, difficult accesses, venipuncture and improved first-pass success. Conclusions: Transradial access significantly reduced composite outcome compared to transfemoral access. Ultrasound guidance did not reduce primary outcome compared to standard technique, but significantly improved efficiency and overall success rate of arterial access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •All patients over 18 years of age who present to the cardiac catheter lab
排除标准
- •1.Cardiogenic shock or intubated patients
- •2.Previous CABG
- •3.Negative Allen’s test
- •4.Known difficulties (including previous unsuccessful access) with femoral (i.e. Leriche syndrome, severe peripheral artery disease, large abdominal aortic aneurysm) or radial access (Raynaud syndrome).
- •5.Simultaneous right heart catherisation
- •6.Pregnant
- •7.Haemodialysis patients with an arteriovenous fistula
- •8.Inability to give informed consent or unable to apply with all requirements
