The Guidant Ancure bifurcation endograft: five-year follow-up.
The aim of this study was to provide a 5-year update on the Guidant/Ancure bifurcated endograft clinical trial. The Guidant trial was a prospective, nonrandomized comparative control designed to evaluate the immediate and long-term results of a bifurcated endograft repair of abdominal aortic aneurysm compared with an open control group. The experimental group consisted of 573 patients, all of whom were followed up for one year, a cadre of 319 patients who were followed up for 5 years, and the control group that consisted of 111 patients who were also followed up for 5 years. A total of 92.7% of the endograft patients underwent successful implantation. Thirty-day mortality rate for the endovascular group was 1.7% compared with 2.7% for the open repair group (P value, not significant). Endovascular repair showed statistically significant improvement in items of resource utilization including reduced blood loss, reduced utilization of intensive care unit (ICU), and shortened hospital stay. There was also a statistically significant reduction in major morbid events (28.8% aggregate) when compared with open surgical control (41.1% aggregate). At the end of the 5-year interval, there was no statistically significant difference in survival rate between the 2 groups, and no patient in the endograft group suffered from aneurysm sac rupture. Endovascular repair of an abdominal aortic aneurysm using a Guidant bifurcated graft resulted in a statistically significant reduction of perioperative morbidity, was conserving of hospital resources, has a comparable long-term survival with open surgical repair, and protected patients from aneurysm rupture when followed up to 5 years.
Moore
Wesley S
WS
Division of Vascular Surgery, UCLA Center for the Health Sciences, 10833 LeConte Avenue, Room 72-156, Los Angeles, CA 90095-6904, USA.
D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D001019:Aortic Rupture / Q000209:etiology; D001807:Blood Vessel Prosthesis / Q000009:adverse effects*; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods*; D016022:Case-Control Studies; D005500:Follow-Up Studies; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies