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Abstract

Few data are available on the long-term outcome of endovascular repair of abdominal aortic aneurysm as compared with open repair. From 1999 through 2004 at 37 hospitals in the United Kingdom, we randomly assigned 1252 patients with large abdominal aortic aneurysms (> or = 5.5 cm in diameter) to undergo either endovascular or open repair; 626 patients were assigned to each group. Patients were followed for rates of death, graft-related complications, reinterventions, and resource use until the end of 2009. Logistic regression and Cox regression were used to compare outcomes in the two groups. The 30-day operative mortality was 1.8% in the endovascular-repair group and 4.3% in the open-repair group (adjusted odds ratio for endovascular repair as compared with open repair, 0.39; 95% confidence interval [CI], 0.18 to 0.87; P=0.02). The endovascular-repair group had an early benefit with respect to aneurysm-related mortality, but the benefit was lost by the end of the study, at least partially because of fatal endograft ruptures (adjusted hazard ratio, 0.92; 95% CI, 0.57 to 1.49; P=0.73). By the end of follow-up, there was no significant difference between the two groups in the rate of death from any cause (adjusted hazard ratio, 1.03; 95% CI, 0.86 to 1.23; P=0.72). The rates of graft-related complications and reinterventions were higher with endovascular repair, and new complications occurred up to 8 years after randomization, contributing to higher overall costs. In this large, randomized trial, endovascular repair of abdominal aortic aneurysm was associated with a significantly lower operative mortality than open surgical repair. However, no differences were seen in total mortality or aneurysm-related mortality in the long term. Endovascular repair was associated with increased rates of graft-related complications and reinterventions and was more costly. (Current Controlled Trials number, ISRCTN55703451.) 2010 Massachusetts Medical Society

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Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.

Dolores Cikrit, K Swanson, Gloria H Y Lin … (2009)

Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. To compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. A randomized, multicenter clinical trial of 881 veterans (aged > or = 49 years) from 42 Veterans Affairs Medical Centers with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report describes the period between October 15, 2002, and October 15, 2008. Elective endovascular (n = 444) or open (n = 437) repair of AAA. Procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs 3.0%; P = .004), but there was no significant difference in mortality at 2 years (7.0% vs 9.8%, P = .13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechanical ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. In this report of short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures. clinicaltrials.gov Identifier: NCT00094575.

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Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population.

Kelly Schermerhorn, Frank Pomposelli, James A O’Malley … (2008)

Randomized trials have shown reductions in perioperative mortality and morbidity with endovascular repair of abdominal aortic aneurysm, as compared with open surgical repair. Longer-term survival rates, however, were similar for the two procedures. There are currently no long-term, population-based data from the comparison of these strategies. We studied perioperative rates of death and complications, long-term survival, rupture, and reinterventions after open as compared with endovascular repair of abdominal aortic aneurysm in propensity-score-matched cohorts of Medicare beneficiaries undergoing repair during the 2001-2004 period, with follow-up until 2005. There were 22,830 matched patients undergoing open repair of abdominal aortic aneurysm in each cohort. The average age of the patients was 76 years, and approximately 20% were women. Perioperative mortality was lower after endovascular repair than after open repair (1.2% vs. 4.8%, P<0.001), and the reduction in mortality increased with age (2.1% difference for those 67 to 69 years old vs. 8.5% for those 85 years or older, P<0.001). Late survival was similar in the two cohorts, although the survival curves did not converge until after 3 years. By 4 years, rupture was more likely in the endovascular-repair cohort than in the open-repair cohort (1.8% vs. 0.5%, P<0.001), as was reintervention related to abdominal aortic aneurysm (9.0% vs. 1.7%, P<0.001), although most reinterventions were minor. In contrast, by 4 years, surgery for laparotomy-related complications was more likely among patients who had undergone open repair (9.7%, vs. 4.1% among those who had undergone endovascular repair; P<0.001), as was hospitalization without surgery for bowel obstruction or abdominal-wall hernia (14.2% vs. 8.1%, P<0.001). As compared with open repair, endovascular repair of abdominal aortic aneurysm is associated with lower short-term rates of death and complications. The survival advantage is more durable among older patients. Late reinterventions related to abdominal aortic aneurysm are more common after endovascular repair but are balanced by an increase in laparotomy-related reinterventions and hospitalizations after open surgery. Copyright 2008 Massachusetts Medical Society.

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Endovascular repair of aortic aneurysm in patients physically ineligible for open repair.

Tara L. Brown, S. Thompson, Louise C Brown … (2010)

Endovascular repair of abdominal aortic aneurysm was originally developed for patients who were considered to be physically ineligible for open surgical repair. Data are lacking on the question of whether endovascular repair reduces the rate of death among these patients. From 1999 through 2004 at 33 hospitals in the United Kingdom, we randomly assigned 404 patients with large abdominal aortic aneurysms (> or = 5.5 cm in diameter) who were considered to be physically ineligible for open repair to undergo either endovascular repair or no repair; 197 patients were assigned to undergo endovascular repair, and 207 were assigned to have no intervention. Patients were followed for rates of death, graft-related complications and reinterventions, and costs until the end of 2009. Cox regression was used to compare outcomes in the two groups. The 30-day operative mortality was 7.3% in the endovascular-repair group. The overall rate of aneurysm rupture in the no-intervention group was 12.4 (95% confidence interval [CI], 9.6 to 16.2) per 100 person-years. Aneurysm-related mortality was lower in the endovascular-repair group (adjusted hazard ratio, 0.53; 95% CI, 0.32 to 0.89; P=0.02). This advantage did not result in any benefit in terms of total mortality (adjusted hazard ratio, 0.99; 95% CI, 0.78 to 1.27; P=0.97). A total of 48% of patients who survived endovascular repair had graft-related complications, and 27% required reintervention within the first 6 years. During 8 years of follow-up, endovascular repair was considerably more expensive than no repair (cost difference, 9,826 pounds sterling [U.S. $14,867]; 95% CI, 7,638 to 12,013 [11,556 to 18,176]). In this randomized trial involving patients who were physically ineligible for open repair, endovascular repair of abdominal aortic aneurysm was associated with a significantly lower rate of aneurysm-related mortality than no repair. However, endovascular repair was not associated with a reduction in the rate of death from any cause. The rates of graft-related complications and reinterventions were higher with endovascular repair, and it was more costly. (Current Controlled Trials number, ISRCTN55703451.) 2010 Massachusetts Medical Society