Preliminary Data Presented From the CARIBE Trial of Aortoiliac Endografting With a Branched Stent Graft
April 17, 2019—Preliminary data from the CARIBE trial were presented by Professor Fabio Verzini, MD, at the 2019 Charing Cross Symposium, held April 15–18 in London, United Kingdom. The findings demonstrated that endovascular aneurysm repair using an off-the-shelf iliac branched stent graft improves the short-term quality of life and maintains walking capacity for patients with aortoiliac aneurysms.
Prof. Verzini is the lead investigator of the prospective, multicenter, single-arm CARIBE trial, which is a comparison of aortoiliac repair with an iliac branch endoprosthesis (IBE). The study enrolled 102 patients with aortoiliac aneurysms at 13 sites in Italy to establish the safety and efficacy of aortoiliac endografting with an off-the-shelf IBE (Excluder, Gore & Associates), as well as assessing the short- and midterm impact of the procedure on the patients' quality of life.
The Excluder IBE is indicated for the endovascular treatment of aortoiliac aneurysms in conjunction with Gore's Excluder bifurcated aortic endograft.
The study sought to determine whether maintaining blood flow to the internal iliac artery using a branched stent graft such as Gore's Excluder IBE may reduce complications seen in surgical procedures, such as buttock claudication and erectile dysfunction or major ischemic complications to pelvic organs.
Clinical endpoints of the trial included mortality, abdominal aortic aneurysm-related mortality, reinterventions, and patency. Patient-reported outcomes included quality of life, walking ability, and erectile function.
As summarized in the Charing Cross Symposium announcement, Prof. Verzini reported that the procedure was successful in all the 102 patients enrolled in the study, with one cardiac death and two internal iliac artery occlusions at 30 days. There were two reinterventions, one for a type IC endoleak and one for an access-related complication. At 1 year, there were three deaths (all unrelated to abdominal aortic aneurysm) and one occlusion. No further reinterventions were performed.
Additionally, there was a small improvement in patients’ health-related quality of life, as assessed using the EQ-5D score, from 74% at baseline to 78% at 1 month, returning to 75% at 1 year. Walking capacity was also preserved at 1 year. Erectile function decreased from 13 to 11 (IEEF-5 score)—which would be expected in this elderly population, noted Dr. Verzini in the Charing Cross Symposium press release.