Comparison of EVAR and open repair in patients with small abdominal aortic aneurysms: Can we predict results of the PIVOTAL trial?

Objective: Data from multicenter studies support observation of small abdominal aortic aneurysms (AAAs) over open repair (OR), but the role of endovascular repair (EVAR) is unclear pending outcome of the Positive Impact of EndoVascular Options for Treating Aneurysm earLy (PIVOTAL) trial. Our goal was to predict the outcome of the trial by comparing results of small AAA repair using EVAR vs OR at a tertiary institution. Methods: Using selection criteria of PIVOTAL trial, we reviewed clinical data of 194 consecutive patients, who underwent EVAR or OR for 4.0-5.0 cm AAAs between 1997 and 2004. All-cause and aneurysm-related deaths, complications, reinterventions, ruptures, and conversions were documented; factors affecting outcome were analyzed using χ² tests, Wilcoxon rank-sum tests, logistic regression Kaplan-Meier method with log-rank tests, and Cox proportional hazards regression. Median follow-up was 3.9 years (range, 1 month to 9 years). Results: A total of 194 patients, 162 males, 32 females (mean age: 71 years, range, 46-86) underwent 162 OR and 32 EVAR. EVAR patients were older (mean 74 ± 6 vs 71 ± 7, P = .002), had lower ejection fraction (mean 54 ± 11 vs 61 ± 13, P = .0002), and less likely to have ever smoked (69% vs 85%, P = .03) than OR patients. Thirty-day mortality was 1.3% (2/162) for OR and 0% for EVAR (0/33) (P = not significant [NS]). There were 49 systemic complications (7 EVAR, 42 OR, P = NS) and 10 local complications (3 EVAR, 7 OR, P = NS). During follow-up, there were no conversions and no ruptures. Freedom from reinterventions at 5 years was 83.1% ± 6.9% for EVAR and 95.3% ± 1.8% for OR (P = 0.02). There were 26 deaths (3 EVAR, 23 OR); but no procedure or aneurysm-related death was confirmed after 30 days (cause unknown in 16 deaths, 62%). Survival rates at 1-year were 96.6% ± 3.4% for EVAR and 97.4% ± 1.3% for OR; 5-year rates were 86.9% ± 7.2% ± EVAR and 86.9% ± 3.3% for OR (P = 0.69). Multivariate analysis revealed age (hazard ratio = 1.1 per year, P = .0496) and AAA size (hazard ratio = 13.8 per 1 cm, P = .03) were associated with death but EVAR vs OR was not (P = .23). Conclusion: For repair of small AAAs, results of EVAR vs OR are not different at 5 years at a tertiary institution. Multicenter studies confirmed OR were not superior to observation in these patients. We predict the PIVOTAL study will conclude EVAR is not superior to observation.