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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
542
The SAFER-TAVI trial is randomized study comparing secondary access via a transradial versus transfemoral approach among patients undergoing transfemoral TAVI for aortic valve disease. Secondary access is gained along with primary access at the commencement of the TAVI procedure and is used for aortography before and after valve deployment and for assessment of the primary femoral access site after closure to confirm haemostasis. For patients assigned to radial access, the radial sheath will be removed using a radial band at the end of the procedure. For patients assigned to femoral access, the puncture site will be obtained under ultrasound guidance and fluoroscopic landmark identification. Unless contraindicated, the use of vascular closure devices will be recommended for all femoral cases. The choice of closure device is at the discretion of the operator. Catheters used in the access groups will be 5 or 6 French size at the discretion of the operator.
Alfred Health
Melbourne, Victoria, Australia
Epworth Healthcare
Melbourne, Victoria, Australia
Cabrini Health
Melbourne, Victoria, Australia
All clinically relevant bleeding and all vascular complications
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.
Time frame: 30 days
All clinically relevant bleeding (BARC ≥2), overall and by access site
Using BARC criteria
Time frame: 30 days
All vascular complications, overall and by access site
Using VARC-3 criteria
Time frame: 30 days
All-cause death
Using VARC-3 criteria
Time frame: 30 days
Stroke
Using VARC-3 criteria
Time frame: 30 days
Myocardial infarction
Using VARC-3 criteria
Time frame: 30 days
Major adverse cardiovascular events
The composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
Time frame: 30 days
Length of stay post-procedure
Length of stay post-procedure measured in time (days) from procedure to discharge
Time frame: 30 days
Overall procedure duration
TAVI procedure duration measured in time (minutes)
Time frame: 1 day
Radiation dose
Radiation dose measured as air kerma in milligrays
Time frame: 1 day
Conversion rate to alternative vascular access site
Conversion rate to alternative vascular access site
Time frame: 30 days
Tertiary site utilised to treat vascular complication
Tertiary site utilised to treat vascular complication
Time frame: 30 days
Failure to perform angiogram of primary access site at completion of TAVI
Failure to perform angiogram of primary access site at completion of TAVI
Time frame: 1 day
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