Radial versus femoral secondary access in patients undergoing TAVI - Rationale and Design of the RADIAL-TAVI trial

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe symptomatic aortic stenosis (AS) across most surgical risk categories. Despite its minimally invasive nature, transfemoral TAVI requires both a primary and a secondary arterial access site. While the femoral artery is most commonly used for secondary access, vascular and bleeding complications remain frequent and are associated with adverse outcomes. Observational evidence from TAVI cohorts suggests that radial secondary access may reduce such complications compared to femoral access. The RADIAL-TAVI trial is a prospective, randomized, controlled, multicenter, open-label study designed to compare radial versus femoral secondary access in patients undergoing transfemoral TAVI. A total of 434 patients will be randomized in a 1:1 ratio. The primary endpoint is the incidence of vascular and bleeding complications at the secondary access site within 30 days, adjudicated according to VARC-3 criteria. Secondary endpoints include early safety, cardiovascular mortality, major adverse cardiovascular and cerebrovascular events (MACCE), quality of life, and health economic aspects up to 30 days, as well as long-term mortality up to 12 months. The study is powered to detect a reduction in the primary endpoint from 8% with femoral to 2% with radial access. The RADIAL-TAVI trial will provide the first randomized evidence on the optimal secondary access strategy in transfemoral TAVI. If radial access proves superior, it has the potential to redefine standard practice, reduce complication rates, and improve patient safety and outcomes.