Perioperative mortality following repair of abdominal aortic aneurysms: application of a randomized clinical trial to real-world practice using a validated nationwide data set.

IMPORTANCE: Because of the restrictions applied to the conduct of randomized clinical trials, the risks reported in their comparison of open and endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) may not be applicable to real-world vascular surgical practice. The magnitude of this deviation is indeterminate.
OBJECTIVES: To compare 30-day mortality from the recent Open Vs Endovascular Repair (OVER) Veterans Affairs Cooperative trial with results obtained from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) and to assess temporal trends in perioperative mortality. DESIGN, SETTING, AND PARTICIPANTS: We analyzed data from 21,115 patients who received elective EVAR or open repair for asymptomatic infrarenal AAA between January 1, 2005, and December 31, 2011, in the NSQIP database. We used χ2 and t tests to compare perioperative mortality between groups. Logistic regression was used to analyze perioperative mortality, adjusting for age, sex, race, and comorbidities. The outcomes of the OVER trial were then compared with the national estimates obtained from the NSQIP. MAIN OUTCOMES AND MEASURES: Death within 30 days of surgery.
RESULTS: Perioperative mortality was 3.7% (95% CI, 3.2%-4.3%) after open repair and 1.3% (95% CI, 1.2%-1.5%) after EVAR. There was a 70% reduction in operative mortality after EVAR compared with open repair (adjusted odds ratio [aOR], 0.30; 95% CI, 0.25-0.38; P < .001). Mortality was significantly lower in men compared with women (aOR, 0.73; 95% CI, 0.57-0.92; P = .009). Thirty-day mortality in the NSQIP cohort was higher than that reported in the OVER trial for both EVAR and open repair (EVAR, 1.3% vs 0.2%; open, 3.7% vs 2.3%). There was an increase in the proportion of patients who received EVAR during the 7 years studied (65% in 2005 and 80% in 2011). There has been no significant decrease in perioperative mortality during these years (P > .05). CONCLUSIONS AND RELEVANCE: Perioperative mortality reported by the OVER trial is significantly lower than outcomes from practices outside the restriction of randomized clinical trials. We attribute this difference to the fact that the OVER trial excluded high-risk patients deemed unfit for open repair. This finding supports the need for individualized assessment of risk and treatment selection for patients with infrarenal AAA. There has been no change in perioperative mortality after EVAR in recent years despite improvements in techniques, devices, and proficiency.

RCT Entities:   Population Interventions Outcomes