A multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysm.

Abstract

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.

SUMMARY:

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.

• Authors: Jon S Matsumura, David C Brewster, Michel S Makaroun, David C Naftel
• Journal: Journal of vascular surgery (J Vasc Surg) Vol. 37 Issue 2 Pg. 262-71 (Feb 2003) ISSN: 0741-5214 [Print] United States
• PMID: 12563194 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Controlled Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Topics

• Aged
• Aortic Aneurysm, Abdominal (diagnostic imaging, mortality, surgery)
• Blood Vessel Prosthesis (adverse effects)
• Blood Vessel Prosthesis Implantation (adverse effects)
• Female
• Follow-Up Studies
• Humans
• Male
• Outcome Assessment, Health Care
• Postoperative Complications
• Radiography
• Severity of Illness Index
• Survival Rate
• Time Factors
• Vascular Surgical Procedures (adverse effects)