In a podium-first presentation on the final day of the 2024 Charing Cross (CX) International Symposium (23–25 April, London, UK), Sean Lyden (Cleveland Clinic, Cleveland, USA) disclosed an interim analysis from the JAGUAR trial and, in doing so, gave delegates an early window into potential real-world outcomes with the Alto stent graft (Endologix).
Lyden initially noted that the device in question has been designed to treat a wide range of abdominal aortic aneurysm (AAA) cases via endovascular aneurysm repair (EVAR), even in some of the most difficult anatomical features in these patients. He also described JAGUAR as a postmarket, prospective, multicentre randomised controlled trial (RCT), intending to enrol a total of 450 patients (300=Alto, 150=comparator) across 60 US and European sites, with planned follow-up out to five years.
As of February 2024, the study had enrolled 272 (180=Alto, 92=comparator) of its target of 450 patients, with 28 sites having already been activated. According to Lyden, enrolment is expected to be complete by Q2 2025, while investigators estimate five-year data being available in 2030.
Regarding relevant events through 30 days in JAGUAR—as per an interim analysis of the study’s findings to date—Lyden relayed a slightly higher rate of complications in the comparator group versus the Alto group. However, the Alto group patients have experienced a slightly greater rate of Type Ib and II endoleaks at 30 days, he added, also noting no conversions, occlusions or ruptures in either group.
Moving on to relevant one-year events, Lyden said there has been a slightly higher rate of total secondary interventions with Alto, while there was a marginally increased presence of Type II endoleaks in the comparator compared to the Alto group. Another observation he reported was the fact that the Type Ib endoleaks in the Alto group at 30 days were no longer present at one year.
Prior to concluding, Lyden informed the CX audience that there was very little increase in sac diameter sizes at six months, and one year, across both groups, and that there were no reports of neck dilatation noted for any patients in the trial at the time of this interim analysis.
In summary, the presenter stated that anticipated core-lab analyses at one year will provide information on aneurysm-related complications and robust neck dilatation data on Alto, when comparing Alto with other commercially available devices. He also noted that JAGUAR will provide insights on quality, long-term, level-one evidence, and its results “will shape optimal treatment strategies” and shed light on enhancing patient outcomes.
