sing ultrasound guided access to radial and femoral arteries to reduce bleeding in patients undergoing coronary angiography or angioplasty

Not Applicable

Completed

• Conditions: Vascular complications; Coronary angiography; Coronary angioplasty; Cardiovascular - Coronary heart disease; Surgery - Surgical techniques

• Registration Number: ACTRN12611000489998
• Lead Sponsor: Dr Phong Nguyen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-10
• Study Completion: 2017-12-16
• Last Update Posted: 16 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1388

Inclusion Criteria

All patients over 18 years of age who present to the cardiac catheter lab

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Bleeding as defined by the ACUITY TRIAL. That is:<br><br>* A reduction in haemoglobin level of at least 4g/dL without an overt bleeding source or at least 3g/dL with such a source.<br>* Intracranial or intraocular bleeding.<br>* Haemorrhage at the access site requiring intervention.<br>* Retroperitoneal bleed.<br>* Presence of a haematoma of at least 5cm in diameter.<br>* Reoperation for bleeding, or<br>* Transfusion of a blood product.[1 week, 30 days]

Secondary Outcome Measures

Name	Time	Method
Vascular complications such as pseudoaneurysm, arteriovenous fistulas, compartment syndrome or limb ischemia resulting in the need for vascular surgery. This will be assessed 1 week after the procedure by a vascular surgeon using ultrasound. <br><br>There will be a 30 day follow-up via telephone.[1 week, 30 days];The composite endpoint of major adverse cardiovascular events (MACE), including death, myocardial infarction, urgent target lesion revascularisation and stroke[1 week, 30 days];Procedural failure, this is defined as the need to access a second site due to the inability to cannulate the randomised approach.[At time of procedure]