Trial Set to ADVANCE Knowledge in Sac Regression

An important head-to-head randomized controlled trial (RCT) of 2 leading aortic stent-graft systems were discussed on Wednesday by Hence Verhagen, Chief of Vascular Surgery at Erasmus University Medical Center (Rotterdam, the Netherlands). Together with Marc Schermerhorn (Beth Israel Deaconess Medical Center, Massachusetts), Professor Verhagen is the co-principal investigator of the ADVANCE RCT comparing the Endurant II/IIs Stent Graft System (Medtronic) and Gore Excluder/Excluder Conformable AAA Endoprosthesis (W. L. Gore & Associates).¹

The ADVANCE trial is a global, post-market, prospective, interventional, multicenter, randomized study that will enroll an estimated minimum of 550 patients at over 50 centers globally. “Patients will be randomized to receive endovascular aneurysm repair (EVAR) with either the Endurant family or Excluder family grafts and will be followed at 1 month, 1 year, and annually through 5 years using computed tomography [CT] imaging,” Professor Verhagen told LINC Today. “This study was designed to enable physicians to make evidence-based clinical decisions improving long-term patient outcomes.”

ADVANCE aims to deepen evidence of sac regression as a key indicator of long-term EVAR patient outcomes through robust evaluation of CT imaging (by an independent core lab) through 5 years. The trial will provide a comparison of sac regression at all times via CT imaging of 2 leading grafts with differing design features. “If there is a difference in sac regression rates, the study will investigate risk factors that contribute to failure,” explained Professor Verhagen. “Furthermore, the study will investigate if a difference in sac regression between the 2 grafts leads to a long-term difference in secondary interventions and all-cause mortality.”

Due to the robust, consistent imaging over the life of the study, baseline risk factors (anatomic features, true lumen volume, thrombus) will be able to be studied along with early outcomes related to endoleaks and their effect on sacs that fail to regress, he said. “The imaging will allow, for the first time, a uniform comparison of sac dynamics and help us to understand sac dynamics over the life of the study,” he said. “It will help investigate sac volume as a predictor for long-term outcomes.”

Volume has been shown to be a more sensitive predictor of long-term outcomes, added Professor Verhagen, but has not been studied on the scale of the ADVANCE trial (including the ability to compare outcomes of both grafts).

The trial will enable the physician community and stent-graft manufacturers to more precisely understand the mechanism behind aneurysm sac regression via the analysis of consistent imaging, independent event evaluation, and robust and consistent high-quality data, underlined Professor Verhagen.

“Potential outcomes for the study are to provide treatment recommendations, update surveillance recommendations, and further solidify sac regression as a critical early indicator of long-term success,” he said. 

In addition to sac regression, the trial will also compare other key clinical outcomes between the 2 stent grafts. “The ADVANCE trial will further knowledge about the impact of device choice on clinical outcomes, so it can contribute to improving long-term treatment and outcomes for patients,” explained Professor Verhagen. 

“This is also a good time to mention the release of the ENGAGE OUS registry,” said Professor Verhagen, who spoke about the 10-year Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) data in the opening talk this morning in Main Arena 2.“The Endurant AAA stent graft system is the first and only EVAR system with a decade of global registry outcomes demonstrating durability,“ he said. 

In terms of the 2 devices within the ADVANCE trial, the grafts have key design differences, noted Professor Verhagen: “The Endurant family has suprarenal fixation that separates the fixation and sealing zone, and is constructed of polyester fabric. The Excluder family has infrarenal fixation with similar location for sealing and fixation, and is constructed of polytetrafluoroethylene. There have been varying results regarding the effect of suprarenal vs infrarenal fixation.”

Some publications have indicated that there is decreased renal function with suprarenal fixation, stressed Professor Verhagen, while others have demonstrated that there is no difference in long-term renal outcomes. “Most physicians and publications have indicated that randomized data would help provide further evidence to compare the effects of suprarenal vs infrarenal fixation,” he added.

“The ADVANCE trial will add significant data on current treatment results, abdominal aortic aneurysm sac dynamics, secondary interventions, all-cause mortality, and the influence of specific endografts.” 

REFERENCE

1. Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial (ADVANCE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT05378347; accessed June 2023.