title: Economic analysis of endovascular repair versus surveillance for patients with small abdominal aortic aneurysms.
abstract: BACKGROUND
  The Positive Impact of EndoVascular Options for Treating Aneurysms Early (PIVOTAL) trial enrolled individuals with small (4.0- to 5.0-cm diameter) abdominal aortic aneurysms (AAA) and reported no difference in rupture or aneurysm-related death for patients who received early endovascular repair (EVAR) vs surveillance with serial imaging studies. We evaluated resource use, medical cost, and quality of life outcomes associated with the PIVOTAL treatment strategies.
  
  
  METHODS
  This prospective economic and quality of life study was conducted within a randomized trial, with PIVOTAL sites participating in the quality of life (n = 67) and economic (n = 63) studies. The PIVOTAL trial randomized 728 patients (366 early EVAR and 362 surveillance). We used information from 701 quality of life (351 early EVAR and 350 surveillance) and 614 economic (314 early EVAR and 300 surveillance) study participants enrolled in the PIVOTAL trial. The main outcome measures were total medical costs and the aneurysm repair rate at 48 months.
  
  
  RESULTS
  After 6 months, the rate of aneurysm repair was 96 vs 10 per 100 patients in the early EVAR and surveillance groups, respectively (difference, 86; 95% confidence interval [CI], 82-90; P < .0001), and total medical costs were greater in the early EVAR group ($33,471 vs $5520; difference, $27,951; 95% CI, $25,156-$30,746; P < .0001). In months 7 through 48, however, the rate of aneurysm repair was 54 per 100 patients in the surveillance group, and total medical costs were higher for patients in the surveillance vs the early EVAR group ($40,592 vs $15,197; difference, $25,394; 95% CI, $15,184-$35,605; P < .0001). At 48 months' follow-up, early EVAR patients had greater cumulative use of AAA repair (97 vs 64 per 100 patients; difference, 34; 95% CI, 21-46; P < .0001), but there was no difference in total medical costs ($48,669 vs $46,112; difference, $2557; 95% CI, -$8043 to $13,156; P = .64). After discounting at 3% per annum, total medical costs for early EVAR and surveillance patients remained similar ($47,765 vs $43,532; difference, 4232; 95% CI, -$5561 to $14,025; P = .40). There were no treatment-related differences in quality of life at 24 months.
  
  
  CONCLUSIONS
  A treatment strategy involving early repair of smaller AAA with EVAR is associated with no difference in total medical costs at 48 months vs surveillance with serial imaging studies. Longer follow-up is required to determine whether the late medical cost increases observed for surveillance will persist beyond 48 months.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. eric.eisenstein@duke.edu
authors.forename: Eric L
authors.initials: EL
authors.lastname: Eisenstein
authors.forename: Linda
authors.initials: L
authors.lastname: Davidson-Ray
authors.forename: Rex
authors.initials: R
authors.lastname: Edwards
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Anstrom
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ouriel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000191:economics / Q000401:mortality / Q000523:psychology / Q000601:surgery / Q000628:therapy*; D001027:Aortography / Q000191:economics / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000191:economics* / Q000401:mortality; D016009:Chi-Square Distribution; D057510:Endovascular Procedures / Q000009:adverse effects / Q000191:economics* / Q000401:mortality; D005260:Female; D017048:Health Care Costs; D006295:Health Resources / Q000191:economics* / Q000706:statistics & numerical data; D017721:Hospital Costs; D006801:Humans; D007902:Length of Stay / Q000191:economics; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D014057:Tomography, X-Ray Computed / Q000191:economics; D016896:Treatment Outcome; D057832:Watchful Waiting / Q000191:economics*