Radial Versus Femoral Secondary Access in Patients Undergoing TAVI: Rationale and Design of the RADIAL-TAVI Trial

Area of Science:

• Cardiovascular Interventions
• Medical Device Technology

Background:

• Transcatheter aortic valve implantation (TAVI) is standard for severe aortic stenosis.
• Transfemoral TAVI necessitates primary and secondary arterial access.
• Femoral secondary access is common but linked to vascular and bleeding complications.

Purpose of the Study:

• To compare the safety and efficacy of radial versus femoral secondary access in transfemoral TAVI.
• To evaluate the incidence of vascular and bleeding complications at the secondary access site.

Main Methods:

• The RADIAL-TAVI trial is a prospective, randomized, controlled, multicenter, open-label study.
• 434 patients will be randomized 1:1 to radial or femoral secondary access.
• Primary endpoint: vascular and bleeding complications within 30 days (VARC-3 criteria).

Main Results:

• Study powered to detect a significant reduction in complications with radial access (2% vs. 8% with femoral).
• Secondary endpoints include safety, mortality, MACCE, quality of life, and health economics.
• Long-term mortality up to 12 months will also be assessed.

Conclusions:

• The RADIAL-TAVI trial will provide the first randomized evidence on optimal secondary access in TAVI.
• Results may redefine standard practice, reduce complications, and enhance patient safety.
• Radial access has the potential to improve outcomes in transfemoral TAVI procedures.