Fully percutaneous EVAR obtains positive results in randomised controlled trial

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Endologix has announced the Journal of Vascular Surgery’s (JVS) e-publication of the data from the first prospective, multicentre, randomised clinical trial of a totally percutaneous approach (PEVAR) to endovascular abdominal aortic aneurysm repair (EVAR).

The paper is titled “A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial)”. The investigators have reported the results comparing PEVAR using the Endologix sheath-based system delivered using a percutaneous approach (the “pre-close” technique) with the Perclose ProGlide Suture-Mediated Closure System from Abbott Vascular, with surgical access EVAR (SEVAR).

The trial met the primary endpoint of treatment success, demonstrating non-inferiority of PEVAR to SEVAR (p<0.004). Procedural technical success of PEVAR in the multicentre setting was 94%. The mean procedure time and the time to haemostasis were reduced in the PEVAR arm by 34 minutes (p=0.006) and 13 minutes (p=0.002), respectively. Additional clinical utility measures with trends favouring PEVAR included reduced anaesthesia time, reduced blood loss and need for transfusion, shorter hospital length of stay, and fewer analgesics prescribed for groin pain.

The paper author and study principal investigator, Peter R Nelson, assistant professor of Vascular Surgery, University of Florida, Gainesville, USA, has received the Southern Association for Vascular Surgery (SAVS) Presidential Award in recognition for this outstanding contribution to the science of vascular surgery.

On the basis of the PEVAR trial, the US Food and Drug Administration granted expanded labeling for the AFX Endovascular AAA System, with specific indication for PEVAR (including a bilateral percutaneous approach).