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 rate in patients undergoing intervention.

Materials and Methods: This was a prospective, multicenter, core-lab reviewed, CEC-adjudicated registry to evaluate the safety and efficacy of dedicated radial devices in complex peripheral vascular disease. A total of 120 patients at 8 US centers were enrolled from June 2020 to June 2021 and followed for 30 days, with a subset of stented participants followed for 12 months. The primary safety endpoint included evaluation of transradial access related complications (bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, RAO, embolic stroke or transient ischemic attack). The primary efficacy endpoint was procedural success, defined as successful completion of the intended procedure without transradial access complications during the procedure and conversion from radial to femoral access.

Results: A total of 224 lesions were treated. Initial access to radial artery was achieved in 120 of 120 (100%) of patients, with 1 patient requiring conversion to femoral access to complete procedure. Twenty-nine of 120 (24.2%) patients required one or more additional access sites to facilitate crossing 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 in 120 (0.8%). Twenty-four of 120 (20.0%) patients had nonserious 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 of 120 (95.8%). The mean procedure time was 74 minutes, and the time to ambulation was 3 hours, 31 minutes.

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 peripheral artery disease (NCT04371861).