Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Overview
- Phase
- N/A
- Intervention
- Access site
- Conditions
- Valve Stenoses, Aortic
- Sponsor
- The Alfred
- Enrollment
- 542
- Locations
- 3
- Primary Endpoint
- All clinically relevant bleeding and all vascular complications
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.
Investigators
Jennifer Zhou
Principal Investigator
The Alfred
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years
- •Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
- •Suitable radial and secondary femoral access
Exclusion Criteria
- •Primary arterial access via surgical cut-down
- •Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist
- •Previously failed attempt to access bilateral radial arteries.
- •Patient on hemodialysis
Arms & Interventions
Radial secondary access
Intervention: Access site
Femoral secondary access
Intervention: Access site
Outcomes
Primary Outcomes
All clinically relevant bleeding and all vascular complications
Time Frame: 30 days
The composite of all clinically relevant bleeding (defined as Bleeding Academic Research Consortium \[BARC\] type ≥2) and vascular complications (Valve Academic Research Consortium \[VARC3\] criteria) at 30 days.
Secondary Outcomes
- All clinically relevant bleeding (BARC ≥2), overall and by access site(30 days)
- All vascular complications, overall and by access site(30 days)
- All-cause death(30 days)
- Stroke(30 days)
- Myocardial infarction(30 days)
- Major adverse cardiovascular events(30 days)
- Length of stay post-procedure(30 days)
- Overall procedure duration(1 day)
- Radiation dose(1 day)
- Conversion rate to alternative vascular access site(30 days)
- Tertiary site utilised to treat vascular complication(30 days)
- Failure to perform angiogram of primary access site at completion of TAVI(1 day)