Terumo Medical Corporation has announced late-breaking data showing the safety and efficacy of radial to peripheral (R2P) interventions with the R2P Misago self-expanding peripheral stent in lower extremity endovascular interventions via a radial approach. The results were presented at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference (16–19 September, Boston, USA).
Presented by Yulanka Castro-Dominguez (University Hospitals’ Harrington Heart & Vascular Institute, Cleveland, USA), the study results showed that using a radial approach in treatment of complex lower extremity peripheral arterial disease (PAD) allowed 92.3% of patients to be discharged the same day. In addition, there were no serious access site complications for any of the patients enrolled in the study.
“In the invasive management of patients with PAD, the ‘radial first’ approach is beginning to gain momentum,” said Michael Martinelli, chief medical officer of Terumo Medical Corporation. “Radial artery access has been shown to minimise bleeding and vascular complications, lessen mortality rates, reduce costs, and shorten length of stay compared to femoral access in patients undergoing percutaneous coronary intervention (PCI), and we are now seeing growing evidence for similar benefits in peripheral arterial intervention. Our study contributes significantly to this expanding body of evidence as it clearly demonstrates the safety and efficacy of radial access in PAD intervention.”
The study was a prospective, multicentre, core-lab reviewed, clinical endpoint committee (CEC) adjudicated, single-arm study aimed at evaluating the safety and feasibility of radial access when used in the treatment of complex lower extremity PAD. A total of 120 PAD patients with Rutherford classification 2–5, from eight medical centres from across the USA were enrolled from 29 June, 2020 to 24 June, 2021 and followed up to one year.
In the final analysis, the primary safety endpoint included evaluation of radial access related complications, to include: access site bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, radial artery occlusion, embolic stroke or transient ischemic attack (TIA). Based on CEC adjudication, primary safety events categorized as serious access site-related adverse events did not occur in any patient. Radial access was successfully achieved in 100% of patients.
Patients who received R2P Misago self-expandable bare metal stent were later followed up to 12 months and the reintervention on the target lesion was required only in two patients.
The study was sponsored by Terumo Medical Corporation. Dedicated Terumo radial devices used in this study included: R2P Destination Slender guiding sheath, R2P Metacross RX percutaneous transluminal angioplasty (PTA) balloon dilatation catheter, R2P Crosstella RX PTA balloon dilatation catheter, R2P Misago self-expandable bare metal stent and TR Band radial compression device.