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The Patient Trial: A Prospective Consecutive Observatinal Study Of Open (OR), Endovascular Abdominal Aortic Aneurysm Repair (EVAR) And Best Medical Treatment Alone (BMT) In High-Risk Patients Suitable For EVAR

Niamh Hynes, Sherif Sultan.
Western Vascular Institute, Galway, Ireland.

OBJECTIVES: EVAR trials have thrown skepticism and qualm on the optimal management and natural history of high risk patients for OR.
From 2001-2006, 780 patients with aortic disease were referred. We performed a parallel group comparison of 162 high-risk elective patients who were anatomically suitable for EVAR. OR (n=52), EVAR (n=66) or BMT (n=44). High-risk was defined in accordance with SVS/AAVS co-morbidity, anatomic severity scores and Kertal customized probability model (KCPM). Primary endpoint was Aneurysm-related survival. Secondary endpoints were all-cause survival, secondary-intervention free survival, Length of hospital stay (LHS) and Cost effectiveness.

METHODS: BMT patients were older (mean +/-SD, BMT=80.9+/-6.7yrs, EVAR=74.6+/-6.3yrs, OR=72.6+/-7.3yrs, p<0.001), but there was no difference in KCPM (p=0.116) or co-morbidity severity scores (p=0.0953) between groups.
Mean Aneurysm diameter was smaller in the EVAR (p=0.0025) (OR 6.3+/-1.7cm, EVAR 5.4+/-1.1cm, BMT=6.2+/-1.7cm) but there was no difference in SVS anatomical severity scores (P>0.05) and in primary technical and clinical success rates (p>0.05)
Four years aneurysm-related survival following EVAR (96.7%) was not statistically different from OR (93.9%, p=0.483, hazard ratio (HR) =0.53 [95%CI=0.09 to 3.09]), however there was an improvement in aneurysm-related survival compared to BMT (66.8%, p=0.0021, HR=0.08, 95%CI (0.024 to0.26).

RESULTS: Four years cumulative all-cause survival following EVAR (78.8%) was not statistically different from OR (84.9%, p=0.59, HR =1.3 [95%CI=0.50 to 3.36]), but was better compared to BMT (27.9%, p=0.0005, HR=0.30, 95%CI (0.16 to0.57).
At 4 years intervention-free survival rate for EVAR (94.5%) was similar to OR (98.1%, p=0.410, HR=2.51, [95%CI=0.35 to 18.0]).
Mean LHS and HDU stay were reduced with EVAR (10.2 and 0.5 days) compared with OR (20.4 and 6.8days) (p<0.0001 for both).30-day morbidity was significantly improved for EVAR (6%) compared to OR (23%) (p=0.007). However, 30-day mortality was not different between EVAR (3.0%) and OR (5.8%),(p=0.653)

CONCLUSIONS: In high-risk patients, EVAR reduced aneurysm-related death compared to BMT. Compared to the gold-standard of OR, EVAR, as a ‘one time procedure’, substantially reduces operative morbidity, hospital stay and utilization of intensive care facilities.