• Safe and Effective: Data Back Radial Access Approach for Peripheral Interventions

    Radial access is both safe and effective in the treatment of complex endovascular lesions in the lower limbs, report data from a prospective, multi-center study.

    Compared to femoral access, radial arterial access has been shown to reduce vascular bleeding, vascular complications, cost, length of stay, and mortality in patients undergoing percutaneous coronary intervention (PCI), said study co-author Yulanka Castro-Dominguez, MD, from the Harrington Heart & Vascular Institute University Hospitals, Cleveland, at Cardiovascular Research Technologies (CRT) 2022 Tuesday in Washington, D.C., during the CRT First Report session.

    As a result, she noted that a “radial first” approach is recommended as the default strategy for the invasive management of patients with acute coronary syndromes, and has also been suggested to also hold promise in reducing femoral access-related complications for peripheral artery disease (PAD).

    Castro-Dominguez presented data from the first prospective, multicenter study with core-lab and CEC adjudication to show the safety and efficacy of radial access for PAD interventions.

    Study details

    She noted that the primary safety endpoint of the trial included an evaluation of transradial access-related complications – including bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, radial artery occlusion, embolic stroke or transient ischemic attack – at 30 days. Meanwhile, the primary efficacy endpoint was procedural success, defined as successful completion of the intended procedure without transradial access complications and conversion from radial to femoral access.

    The study enrolled 120 patients at eight US-based centers between June 2020 and June 2021. The team noted that out of 224 lesions treated, 12.9% were in iliac arteries, 48.2% in superficial femoral artery (SFA) or SFA-popliteal segment, 12.1% were isolated popliteal lesions, 18.3% were below the knee and 8.5% were other lesions.

    “Initial access to radial artery was achieved in 120/120 (100%) of patients, with 1 patient requiring conversion to femoral access to complete procedure,” said Castro-Dominguez, adding that 29 out of 120 (24.2%) patients required one or more additional access sites to facilitate crossing and/or to complete the planned treatment algorithm – femoral five (4.2%), tibial six (5.0%), pedal 17 (14.2%), and other three (2.5%).

    The study reported that primary safety events – defined as serious transradial access site-related adverse events – occurred in none of the participants , while 20% (24 of 120) had non-serious transradial access site complications such as minor hematoma, bruising or access site bleeding that required manual compression, longer TR Band application or no further intervention.

    The primary efficacy endpoint of successful completion of the intended procedure without transradial access complications at procedure and conversion from radial to femoral access was achieved in 115 of the 120 participants – giving a 95.0% efficacy rate.

    “Radial approach allowed 92.3% discharge on the day of the procedure with no serious access site related adverse events,” said the authors, adding a radial artery patency – which was assessed by duplex ultrasound and reviewed by a central core lab – of 97.1% at 30 days “is in line with recently published randomized clinical studies in the treatment of coronary artery disease.”

    Castro-Dominguez concluded with a note that future randomized trials should now examine the clinical and cost effectiveness of the approach over femoral access for patients with PAD.

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