13 - Prospective, Multicenter, CL Adjudicated Registry to Evaluate Safety and Efficacy of Radial to Peripheral Interventions
Purpose: Radial arterial access has been shown to reduce vascular bleeding, complications, cost, length of stay, and mortality in patients undergoing intervention.
Material and Methods: Prospective, multi-center, core-lab reviewed, CEC adjudicated registry to evaluate safety and efficacy of dedicated radial devices in complex peripheral vascular disease. 120 patients at 8 US centers were enrolled from June2020 to June2021 and followed for 30 days; with a sub-set of stented subjects followed for 12 mo. The primary safety endpoint included evaluation of transradial access related complications (bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, RAO, embolic stroke or TIA). The primary efficacy endpoint is procedural success, defined as successful completion of the intended procedure without transradial access complications at procedure and conversion from radial to femoral access.
Results: 224 lesions were treated, initial access to radial artery was achieved in 120/120 (100%) of patients, with 1 patient requiring conversion to femoral access to complete procedure. 29/120 (24.2%) patients required one or more additional access sites to facilitate crossing and/or to complete the planned treatment algorithm (femoral 5 (4.2%), tibial 6 (5.0%), pedal 17 (14.2%), and other 3 (2.5%)). Primary safety events defined as serious transradial access site related adverse events occurred in 1/120 (0.8%). 24/120 (20.0%) patients had non-serious transradial access site complications (i.e. minor hematoma, bruising, access site bleeding) requiring manual compression, longer TR Band application or no further intervention. The primary efficacy endpoint (successful completion of the intended procedure without transradial access complications at procedure and conversion from radial to femoral access) was achieved in 115/120 (95.8%). Mean procedure and time to ambulation was 74min and 3h 31min; respectively.
Conclusions: This is the first prospective, multicenter study with core-lab and CEC adjudication to show the safety and efficacy of radial access in treating complex endovascular lesions in the lower limbs. Radial approach allowed 92.3% discharge on the day of the procedure with only 1 serious access site related adverse event. Future randomized trials should examine the clinical and cost effectiveness of this approach over femoral access for patients with PAD (NCT04371861).