A prospective clinical, economic, and quality-of-life analysis comparing endovascular aneurysm repair (EVAR), open repair, and best medical treatment in high-risk patients with abdominal aortic aneurysms suitable for EVAR: the Irish patient trial.
OBJECTIVE
To report the results of a trial comparing endovascular aneurysm repair (EVAR) to open repair (OR) and best medical therapy (BMT) involving high-risk patients with abdominal aortic aneurysms (AAA) suitable for EVAR.


METHODS
From 2002 to 2007, 1083 patients with aortic aneurysm disease were referred to a tertiary care university hospital. Of these, 162 (119 men; mean age 76 years) were high-risk patients with AAAs anatomically suitable for EVAR. Following comprehensive consultation with the patient, the family, and the primary physician, elective treatment was selected: OR (n=52), EVAR (n=66), or BMT (n=44). Outcomes were compared using Kaplan-Meier survival analyses and a parameter that measured the quality time spent without symptoms of disease or toxicity of treatment (Q-TWIST).


RESULTS
Four-year freedom from aneurysm-related death following EVAR (96.7%) was markedly better compared to BMT (66.8%; p=0.002) and was similar to OR (93.9%, p=0.483). Four-year freedom from major adverse clinical events was significantly better with EVAR (78%) compared with BMT (28%; p=0.001) and was equivalent to OR (75%; p=0.519). The 4-year intervention-free survival rate for EVAR (95%) almost matched OR (98%; p=0.410). At 4 years, Q-TWIST was 3.64 years for EVAR patients, 3.60 years for OR, and 2.22 years for BMT. Q-TWIST significantly improved with EVAR compared to OR (p<0.003). In the cost analysis, 52 high-risk patients were treated with OR over the 5-year period (2002-2007) at a total inpatient cost of 1,257,457 euro. The 66 patients treated with EVAR (14 patients more than OR) incurred a lower cost of 1,129,138 euro. Including the cost of follow-up over 4 years, the mean cost per patient was 18,476 euro for EVAR and 24,252 euro for OR, a savings of 5,776 euro per patient treated with EVAR.


CONCLUSIONS
In high-risk patients, EVAR reduces aneurysm-related death compared to BMT. Equated to the gold standard of open repair, EVAR, as a "one-time procedure," substantially reduces operative morbidity, hospital stay, costs, and utilization of intensive care facilities if performed in a high-volume center.
Hynes
Niamh
N
Department of Vascular Surgery, Western Vascular Institute at the University College Hospital Galway, Ireland.
Sultan
Sherif
S
D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000188:drug therapy / Q000191:economics / Q000401:mortality / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000191:economics; D002317:Cardiovascular Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005240:Feasibility Studies; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007494:Ireland / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D019060:Minimally Invasive Surgical Procedures; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011788:Quality of Life; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents