Two-Year ENGAGE Data Published for Medtronic's Endurant Stent Graft Device

April 29, 2015—ENGAGE, the Endurant Stent Graft Natural Selection Global Postmarket Registry, sought to determine the incidence of and predictive factors for limb occlusion after use of the Endurant stent graft (Medtronic plc) to treat abdominal aortic aneurysms. Else Faure, MD, et al published the 2-year data from ENGAGE in the Journal of Vascular Surgery  (JVS; 2015;61:1138–1145).

The ENGAGE investigators concluded that after Endurant stent grafting, the incidence of limb occlusion was low. Additionally, they found that classifying patients as high risk versus low risk according to the algorithm used in this study may help define specific strategies to prevent limb occlusion and improve the overall results of endovascular aneurysm repair using the latest generation of stent grafts.

As summarized in JVS, ENGAGE prospectively included 1,143 patients who were treated with bifurcated devices and observed for up to 2 years. Limb occlusions were evidenced by computed tomography, angiography, or ultrasound. To predict stent graft limb occlusion, a two-step model-building technique was applied. 

The investigators first identified predictors from a total of 47 covariates obtained at baseline and in the periprocedural period. Subsequently, the set of potential predictors were reduced to key factors that are clinically meaningful. The CART—Classification And Regression Tree—method was used to handle the large number of covariates.

Forty-two stent graft limbs occluded in 39 patients (3.4% of patients). At 2 years, the rate of freedom from stent graft limb occlusion calculated by Kaplan-Meier plot was 97.9%. Of the 42 occlusions, 13 (31%) were observed within 30 days and 30 (71%) within 6 months. The strongest independent predictors were distal landing zone on the external iliac artery, external iliac artery diameter ≤ 10 mm, and kinking. High-risk versus low-risk patients were identified according to a decision tree based on the strongest predictors. Freedom from stent graft limb occlusion was 96.1% in high-risk patients versus 99.6% in low-risk patients, reported the ENGAGE investigators in JVS.