Three Year Results of the Endurant Stent Graft System Post-Approval Study (ENGAGE PAS)
Sarah E. Deery, MD, Thomas F.X. O'Donnell, MD, Katie E. Shean, MD, Jeremy D. Darling, BA, Marc L. Schermerhorn, MD.
Beth Israel Deaconess Medical Center, Boston, MA, USA.
OBJECTIVES: The durability of endovascular aneurysm repair (EVAR) in the modern era is poorly characterized. The aim of the ENGAGE Post-Approval Study is to describe the long-term safety and effectiveness data following EVAR using the Endurant stent graft system. METHODS: From August 2011 to June 2012, 178 patients were enrolled and treated with the Endurant stent graft system. Clinical and radiologic data were prospectively collected and analyzed. The primary endpoint was AAA-related mortality (ARM), and secondary endpoints were overall mortality, endoleak, secondary interventions, and device-related complications. Kaplan-Meier estimates were used to account for censoring in late outcomes. RESULTS: A total of 178 patients underwent EVAR with the Endurant stent graft across 24 centers (82% men; median age 71, interquartile range [IQR] 66-79). Median aortic diameter was 55 mm (IQR 51-58 mm). There was a 98.9% technical success rate. Three-year clinical and radiographic follow-up data were available for 87% and 74% of patients, respectively. Median follow-up was 37 months (IQR 30-38 months). Three-year aneurysm-related mortality was 2 patients (1.1%), both due to perioperative mortality. All-cause mortality at three years was 13%. No patients suffered from aneurysm rupture or underwent conversion to open repair throughout follow-up. Only 11 patients (6.1%) had undergone a reintervention at three years (Table). Quality of life by the EQ-5D was unchanged at three years compared to baseline. CONCLUSIONS: The Endurant stent graft system provides a safe, durable approach to treating infrarenal AAA. No patients experienced late rupture or aneurysm-related mortality, and only 6% of patients underwent reintervention by three years. The rate of reintervention with the Endurant graft appears to be lower than other contemporary grafts, but further research including direct graft comparisons will be necessary to guide appropriate graft selection.
| Three-Year Outcome | 95% Confidence Interval | |
| Death | 13% | 8.8-19% |
| Aneurysm Rupture | 0% | - |
| Any Secondary Intervention | 6.1% | 3.3-11% |
| Endoleak, any | 18% | 12-25% |
| Type IA | 2.1% | 0.7-6.4% |
| Type II | 16% | 11-23% |
| Graft Occlusion | 2.3% | 0.9-5.9% |
| Thrombosis | 0.6% | 0.1-4.1% |
| Peripheral Ischemia | 0.6% | 0.1-4.2% |
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