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April 2024 Supplement
Sponsored by Terumo Interventional Systems
Clinical Study Summary: Prospective, Multicenter Registry to Assess Safety and Efficacy of Radial Access for Peripheral Artery Interventions
A summary of the recently published Terumo R2P study evaluating radial access for endovascular lower extremity intervention.
By Yulanka Castro-Dominguez, MD; Jun Li, MD; Ankur Lodha, MD; Sunthosh Parvathaneni, MD; Justin Ratcliffe, MD; Amit Srivastava, MD; Sanjum S. Sethi, MD, MPH; Mitul Patel, MD; Vamsi Krishna, MD; and Mehdi H. Shishehbor, DO, MPH, PhD
STUDY OBJECTIVE
To prospectively evaluate the safety and feasibility of radial access (RA) for complex endovascular lower extremity interventions.
STUDY DESIGN
- Prospective, multicenter, observational, postmarket study
- Designed to assess the safety and efficacy of RA for endovascular lower extremity interventions
- Eligible patients with peripheral artery disease (PAD) scheduled for intervention through RA were enrolled
PRIMARY ENDPOINTS
- Procedural success, defined as successful completion of the intended procedure without conversion to femoral access and without RA complications periprocedure
- The primary safety endpoint included evaluation of RA-related complications at 30 days
RESULTS
- The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%), and tibial (19.5%) vessels.
- The primary efficacy endpoint was achieved in 112 (93.3%) patients.
- No serious adverse events were adjudicated to the procedure.
- Mean procedure time and time to ambulation were 74 minutes and 3 hours 30 minutes, respectively, with 93.3% same-day discharge.
- At 30 days, 97.2% of patients recorded ultrasound-confirmed RA patency.
Editorial
The study’s findings demonstrate that RA is a safe and effective approach for treating complex multilevel PAD.1 The technique allowed for early ambulation and same-day discharge for most patients, further enhancing patient satisfaction and reducing health care costs.2
CONCLUSION
In this prospective, multicenter registry, we show the safety and efficacy of the RA approach for the treatment of complex multilevel PAD. The RA approach allowed same-day discharge for most patients with no serious adverse events. Future randomized trials should examine the clinical and cost-effectiveness of this approach compared to femoral access for patients with PAD.
1. Castro-Dominguez Y, Li J, Lodha A, et al. Prospective, multicenter registry to assess safety and efficacy of radial access for peripheral artery interventions. J Soc Cardiovasc Angiogr Interv. 2023;2:101107. https://doi.org/10.1016/j.jscai.2023.101107
2. Nanjundappa A, Dieter EG, Dieter RS, et al. Transradial access for peripheral endovascular interventions: a leap toward improved patient safety and improved clinical outcomes. J Soc Cardiovasc Angiogr Interv. 2023;2:101179. https://doi.org/10.1016/j.jscai.2023.101179]
Tables reprinted with permission from J Soc Cardiovasc Angiogr Interv, Vol 2, Castro-Dominguez Y, Li J, Lodha A, et al, Prospective, multicenter registry to assess safety and efficacy of radial access for peripheral artery interventions, Page No 101107, Copyright Elsevier (2023).
©2024. Terumo Medical Corporation. All rights reserved. All brand names are trademarks or registered trademarks of Terumo. PM-07751
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