Aneurysm enlargement following endovascular aneurysm repair: AneuRx clinical trial

OBJECTIVE: The purpose of this study was to determine the incidence and significance of aneurysm enlargement, with or without treatment, in relation to the primary end points of rupture, surgical conversion, aneurysm-related death, and survival following endovascular repair. METHOD: Aneurysm (AAA) size changes and clinical outcome of all patients treated from 1997 through 1998 during the Phase II AneuRx multicenter clinical trial of endovascular AAA repair were reviewed. Aneurysm dimensions and the presence or absence of endoleak were determined by an independent core laboratory, with enlargement or shrinkage defined as a diameter change of 5 mm or more compared with baseline. RESULTS: Among 383 patients (89% men, 11% women, age 73 +/- 9 years), with a mean device implant time of 36 +/- 11 months (median = 39 months), aneurysm diameter decreased from 5.7 +/- 1.0 at baseline to 5.2 +/- 1.0 at 3 years (P =.0001). A total of 46 patients (12%) experienced AAA enlargement, 199 patients (52%) had no change in AAA diameter, and 138 patients (36%) had a decrease in AAA diameter of 5 mm or more. Significant risk factors for enlargement included age (enlargement patients were 4 years older on average than patients with aneurysms that decreased in size; P =.002) and the presence of an endoleak (P <.001). Among patients with endoleak at any time, 17% had aneurysm enlargement, whereas only 2% of patients without endoleak had aneurysm enlargement (P <.001). Patients with enlargement were more likely to undergo secondary endovascular procedures and surgical conversions (P <.001). Twenty patients (43%) with enlargement underwent treatment, and 26 patients were untreated. There were two deaths following elective surgical conversion and one death in a patient with untreated enlargement and a type I endoleak. Three aneurysms ruptured: one with enlargement, one with no change, and one with a decrease in aneurysm size; all three aneurysms were larger than 6.5 cm. Kaplan-Meier analysis showed that freedom from rupture at 3 years was 98% with enlargement, 99% with no change, and 99% with decrease in AAA size (log-rank test, not significant). Freedom from AAA death at 3 years was 93% in patients with enlargement, 99% in no increase, and 99% in decrease (P =.005). Survival at 3 years was 86% with increase, 82% with no change, and 93% with decrease (P =.02). CONCLUSIONS: Aneurysm enlargement following endovascular repair was not associated with an increased risk of aneurysm rupture or decrease in patient survival during a 3-year observation period. Aneurysm size rather than enlargement may be a more meaningful predictor of rupture. Close follow-up and a high re-intervention rate (43%) may account for the low risk of rupture in patients with enlargement. The long-term significance of aneurysm enlargement following endovascular repair remains to be determined.