A multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysm.
OBJECTIVE
The purpose of this study was to evaluate the safety and efficacy of a novel endovascular graft for elective treatment of infrarenal abdominal aortic aneurysm. The device is a modular bifurcated system with nitinol/expanded polytetrafluoroethylene components and a smaller profile than currently approved devices.


METHODS
In a multicenter, concurrent controlled phase II trial, 334 patients underwent treatment with the Excluder bifurcated endoprosthesis (test, n = 235; W. L. Gore & Associates, Inc, Sunnyvale, Calif) or with standard open repair (control, n = 99). Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 2 years were analyzed with univariable and multivariable statistics.


RESULTS
Patients in the test group had less blood loss (310 +/- 19 mL versus 1590 +/- 124 mL; P <.0001), fewer homologous transfusions (6% versus 32%; P <.0001), and shorter lengths of stay (2.0 +/- 0.1 days versus 9.8 +/- 1.4 days; P <.0001). Early major adverse events were markedly reduced in the test group (14% versus 57%; P <.0001), and this difference persisted at 2 years. No difference was seen in survival rate (P =.13). In the first 2 years, no deployment failure, early conversion, or aneurysm rupture occurred. At the 2-year timepoint, core laboratory read trunk migration in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. One wire discontinuity (0.6%) was identified in a discharge film. A 7% annual reintervention rate was seen in the test group in the first 2 years.


CONCLUSIONS
The test device is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysm. The most striking benefits are reduced blood loss, fewer complications, and faster recovery. Two-year survival rate was similar.
Matsumura
Jon S
JS
Northwestern University, Chicago IL 60611, USA. j-matsumura@northwestern.edu
Brewster
David C
DC
Makaroun
Michel S
MS
Naftel
David C
DC
D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis / Q000009:adverse effects*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011183:Postoperative Complications; D011859:Radiography; D012720:Severity of Illness Index; D015996:Survival Rate; D013997:Time Factors; D014656:Vascular Surgical Procedures / Q000009:adverse effects*