Sharing first-time data from the SOCRATES (ShOrt neCK AAA RAndomized Trial) design, Giovanni Torsello (St Franziskus Hospital, Münster, Germany) expanded on the intentions of the prospective, global, multicentre, randomised trial which he stated is the “first comparative” study to compare endovascular aneurysm repair (ESAR) and fenestrated endovascular aneurysm repair (FEVAR).
Presenting the trial parameters at this year’s Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Torsello began by acknowledging the background that provided the foundations of their current study. “Hostile aortic neck can lead to loss of proximal seal over time” he explained, expanding that short necks are associated with increased risk of Type 1A endoleak and secondary procedures. With these outcomes in mind, he asked “how should we treat our patients with a short neck?”, and noted that the options are to either extend the seal zone proximally or reinforce the zone.
First, addressing contemporary data concerning FEVAR and its efficacy, Torsello referenced a paper by Magnús Sveinsson (Helsingborgs lasarett, Helsingborg, Sweden) et al that reported 90% primary target vessel patency at three years. However aneurysm-related mortality in this study was 5.3%, with 39.4% of patients requiring reintervention when treated with FEVAR.
“On the other side” he noted, “we have the five-year results of the ANCHOR registry”—a trial which evaluated the durability of treatment with the Heli-FX EndoAnchor system (Medtronic). Their results currently show freedom from aneurysm-related mortality to be at 90.1%, 95.6% freedom from rupture and 76.9% freedom from any secondary procedures.
“These retrospective analyses of ESAR and FEVAR patients suggest comparable early outcomes”, Torsello stated to the LINC 2023 audience: “Without a difference, we do not know what we should do and it is important we compare, head-to-head, these two types of procedures and this will be a joint venture between the Foundation for Cardiovascular Research and Education [FCRE] and Medtronic.”
The purpose of their study is to compare the safety and performance of ESAR and FEVAR for the treatment of aortic aneurysm patients with infrarenal aortic proximal neck lengths of four to 15mm and minimal proximal sealing zone length of 8mm. Recruiting patients initially from Europe, Torsello stated that they are now extending enrolment to the United States, which he opined will “make a great contribution to this prospective study”.
Speaking on patient selection, the speaker noted that at least 204 patients will be randomised. The ESAR arm will be treated with the Endurant II/IIs Heli-FX EndoAnchor implant and the FEVAR arm with the Cook Zenith Fenestrated or Terumo Fenestrated Anaconda (Europe only) stent graft systems.
Of their primary endpoints, Torsello presented that they will look for a composite of technical success at index procedure, and freedom from Type 1A or Type 3 endoleak, freedom from aneurysm-related mortality and freedom from secondary intervention through to 12-months post-procedure. Follow-up will be recorded at one, 12, 24 and 36 months or up to three years, alongside reporting of adverse events during this period and computed-tomography (CT) angiograms, Torsello explained, reiterating that these measures are so “that we know more about these two types of procedures”.
Summarising their intentions with the SOCRATES study, Torsello conveyed: “If we can build the first comparative trial in the treatment of such patients and we can learn more about the fate of those treated in these ways, it will be a fantastic trial.” Finally, addressing those in attendance at his presentation during LINC 2023, he extended an invite to any centre that wishes to be involved in this study to get in contact.