Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial

Short-term survival benefits of endovascular aneurysm repair (EVAR) compared with open repair (OR) of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is soon lost. Survival benefit of EVAR was unclear at follow-up to 10 years. To assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures (EVAR trial 1; EVAR-1); and against no intervention in patients unfit for OR (EVAR trial 2; EVAR-2). To appraise the long-term significance of type II endoleak and define criteria for intervention. Two national, multicentre randomised controlled trials: EVAR-1 and EVAR-2. Patients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004. Men and women aged ≥ 60 years with an aneurysm of ≥ 5.5 cm (as identified by computed tomography scanning), anatomically suitable and fit for OR were randomly assigned 1 : 1 to either EVAR (n = 626) or OR (n = 626) in EVAR-1 using computer-generated sequences at the trial hub. Patients considered unfit were randomly assigned to EVAR (n = 197) or no intervention (n = 207) in EVAR-2. There was no blinding. EVAR, OR or no intervention. The primary end points were total and aneurysm-related mortality until mid-2015 for both trials. Secondary outcomes for EVAR-1 were reinterventions, costs and cost-effectiveness. In EVAR-1, over a mean of 12.7 years (standard deviation 1.5 years; maximum 15.8 years), we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [adjusted hazard ratio (HR) 1.11, 95% confidence interval (CI) 0.97 to 1.27; p = 0.14]. At 0-6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0.61, 95% CI 0.37 to 1.02 for total mortality; HR 0.47, 95% CI 0.23 to 0.93 for aneurysm-related mortality; p = 0.031), but beyond 8 years of follow-up patients in the OR group had a significantly lower mortality (adjusted HR 1.25, 95% CI 1.00 to 1.56, p = 0.048 for total mortality; HR 5.82, 95% CI 1.64 to 20.65, p = 0.0064 for aneurysm-related mortality). The increased aneurysm-related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture, with increased cancer mortality also observed in the EVAR group. Overall, aneurysm reintervention rates were higher in the EVAR group than in the OR group, 4.1 and 1.7 per 100 person-years, respectively (p < 0.001), with reinterventions occurring throughout follow-up. The mean difference in costs over 14 years was £3798 (95% CI £2338 to £5258). Economic modelling based on the outcomes of the EVAR-1 trial showed that the cost per quality-adjusted life-year gained over the patient's lifetime exceeds conventional thresholds used in the UK. In EVAR-2, patients died at the same rate in both groups, but there was suggestion of lower aneurysm mortality in those who actually underwent EVAR. Type II endoleak itself is not associated with a higher rate of mortality. Devices used were implanted between 1999 and 2004. Newer devices might have better results. Later follow-up imaging declined, particularly for OR patients. Methodology to capture reinterventions changed mainly to record linkage through the Hospital Episode Statistics administrative data set from 2009. EVAR has an early survival benefit but an inferior late survival benefit compared with OR, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. EVAR does not prolong life in patients unfit for OR. Type II endoleak alone is relatively benign. To find easier ways to monitor sac expansion to trigger timely reintervention. Current Controlled Trials ISRCTN55703451. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and the results will be published in full in Health Technology Assessment; Vol. 22, No. 5. See the NIHR Journals Library website for further project information.

To assess the efficacy of endovascular aneurysm repair (EVAR) against standard alternative management in patients with large abdominal aortic aneurysm (AAA). Two national, multicentre randomised trials - EVAR trials 1 and 2. Patients were recruited from 38 out of 41 eligible UK hospitals. Men and women aged at least 60 years, with an AAA measuring at least 5.5 cm on a computerised tomography scan that was regarded as anatomically suitable for EVAR, were assessed for fitness for open repair. Patients considered fit were randomised to EVAR or open repair in EVAR trial 1 and patients considered unfit were randomised to EVAR or no intervention in EVAR trial 2. EVAR, open repair or no intervention. The primary outcome was mortality (operative, all-cause and AAA related). Patients were flagged at the UK Office for National Statistics with centrally coded death certificates assessed by an Endpoints Committee. Power calculations based upon mortality indicated that 900 and 280 patients were required for EVAR trials 1 and 2, respectively. Secondary outcomes were graft-related complications and reinterventions, adverse events, renal function, health-related quality of life and costs. Cost-effectiveness analyses were performed for both trials. Recruitment occurred between 1 September 1999 and 31 August 2004, with targets exceeded in both trials: 1252 randomised into EVAR trial 1 (626 to EVAR) and 404 randomised into EVAR trial 2 (197 to EVAR). Follow-up closed in December 2009 with very little loss to follow-up (1%). In EVAR trial 1, 30-day operative mortalities were 1.8% and 4.3% in the EVAR and open-repair groups, respectively: adjusted odds ratio 0.39 [95% confidence interval (CI) 0.18 to 0.87], p = 0.02. During a total of 6904 person-years of follow-up, 524 deaths occurred (76 AAA related). Overall, there was no significant difference between the groups in terms of all-cause mortality: adjusted hazard ratio (HR) 1.03 (95% CI 0.86 to 1.23), p = 0.72. The EVAR group did demonstrate an early advantage in terms of AAA-related mortality, which was sustained for the first few years, but lost by the end of the study, primarily due to fatal endograft ruptures: adjusted HR 0.92 (95% CI 0.57 to 1.49), p = 0.73. The EVAR procedure was more expensive than open repair (mean difference £1177) and not found to be cost-effective, but the model was sensitive to alternative assumptions. In EVAR trial 2, during a total of 1413 person-years of follow-up, a total of 305 deaths occurred (78 AAA related). The 30-day operative mortality was 7.3% in the EVAR group. However, this group later demonstrated a significant advantage in terms of AAA-related mortality, but this became apparent only after 4 years: overall adjusted HR 0.53 (95% CI 0.32 to 0.89), p = 0.02. Sadly, this advantage did not result in any benefit in terms of all-cause mortality: adjusted HR 0.99 (95% CI 0.78 to 1.27), p = 0.97. Overall, EVAR was more expensive than no intervention (mean difference £10,222) and not found to be cost-effective. EVAR offers a clear operative mortality benefit over open repair in patients fit for both procedures, but this early benefit is not translated into a long-term survival advantage. Among patients unfit for open repair, EVAR is associated with a significant long-term reduction in AAA-related mortality but this does not appear to influence all-cause mortality. Current Controlled Trials ISRCTN 55703451. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 9. See the HTA programme website for further project information.

Comparison of the effects of open and endovascular aortic aneurysm repair on long-term renal function using chronic kidney disease staging based on glomerular filtration rate

The modern open surgical management of abdominal aortic aneurysm (AAA) has changed little since its inception in the 1950s. Endoaneurysmorrhaphy, first described by Rudolph Matas in 1888, involved ligating the branches of an aneurysm from within the aneurysm sac. Approximately 25 years later at the

Clinical Practice Guidelines for Endovascular Abdominal Aortic Aneurysm Repair: Written by the Standards of Practice Committee for the Society of Interventional Radiology and Endorsed by the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association

Recently published long-term outcomes of the UK Endovascular Abdominal Aortic Aneurysm Repair (EVAR) trial investigators and the Dutch Randomized Endovascular Aneurysm Repair group have continued to demonstrate the superiority of EVAR in the perioperative period, but they have failed to establish long-term sustainable durability compared to open repair because of increased graft-related complications and reinterventions.1,2 In 2005, thoracic endovascular aneurysm repair (TEVAR) was approved in the United States for the treatment of descending thoracic aortic aneurysms (DTAAs). This approval, based on the results of a phase II trial3 evaluating the GORE TAG endovascular prosthesis (W.L. Gore and Associates, Newark, Delaware), led to a nationwide explosion in the use of thoracic endovascular techniques for managing DTAAs.4 Physicians had already been performing EVAR for more than a decade. Whereas EVAR was initially used to repair abdominal aneurysms with a favorable anatomy, its use later expanded to include complex cases involving a short aneurysmal neck, a tortuous aorta, and (more recently) aneurysmal rupture. Although TEVAR has only a brief history, a similar trend is obvious: This approach is being used with reasonable success to treat dissections and even ruptured aneurysms5; in addition, various new debranching techniques are allowing TEVAR to be applied to portions of the aorta previously deemed unapproachable. Article see p 2718 Najibi and colleagues6 reported the results of the first study to compare TEVAR with open aortic repair. Their series comprised 18 patients, and the control group included a historic cohort of patients who had undergone open aortic repair during the previous 3 years. Short-term follow-up data showed that the endovascular group had significantly shorter operative times, shorter hospital and intensive-care–unit stays, and less operative blood loss. Subsequently, Bavaria and associates7 reported the results of a phase II multicenter trial that assessed GORE …

Invited commentary

Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial

Open vs endovascular repair of abdominal aortic aneurysm involving the iliac bifurcation

Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial

Volume-Outcome Relationships and Abdominal Aortic Aneurysm Repair

Primary aortoenteric fistula following endovascular aortic repair due to type II endoleak

To quantify the difference in long-term survival and cardiovascular morbidity between women and men undergoing elective abdominal aortic aneurysm (AAA) repair at National Health Service hospitals in England. Patients having elective repair of AAA were reviewed using the Hospital Episode Statistics and Office for National Statistics (ONS) datasets. The primary outcome measure was 30-day mortality and the secondary outcomes were 1-year, 5-year, and aortic-related mortality and post-operative complication rates. We used logistic regression and survival models to assess risk factors on the primary and secondary outcomes. Between 1 April 2002 and 31 March 2013, a total of 31090 patients (4795 women and 26295 men) underwent open AAA repair. Between 1 January 2006 and 31 March 2013, a total of 16777 patients (2036 women and 14741 men) underwent endovascular aneurysm repair (EVAR). All-cause and aortic-related mortalities at 30 days, 1 year, and 5 years were all higher in women, despite a lower prevalence of pre-operative cardiovascular risk factors. Female sex was a significant independent risk factor for 30-day mortality in both open repair [odds ratio (OR) 1.39; 95% confidence interval (CI) 1.25-1.56; P < 0.001] and EVAR (OR 1.57; 95% CI 1.23-2.00; P < 0.001) groups. Based on an all-cause long-term survival model, conditional on 30-day survival, the estimated hazard for women in the open repair group was significantly (P = 0.006) higher than men, but the sex difference was not significant in the EVAR group (P = 0.356). In the open repair group, women had significantly (P < 0.001) higher cumulative incidence probabilities for both aortic-related mortality and other-cause mortality. In the EVAR group, women had significantly (P < 0.001) higher mean cumulative incidence probabilities for the aortic-related mortality compared with men, but not for the other-cause mortality (P = 0.235). Women undergoing elective AAA repair at National Health Service hospitals in England had increased short- and long-term mortality and post-operative morbidity compared with men. These findings can be used to improve pre-operative counselling for women undergoing AAA repair, and highlight the need for female-specific pre-, peri-, and post-operative management strategies.

Japan has adopted its own reimbursement system, which differs from other countries in terms of its diagnostic procedure combination (DPC) methods. However, there are few reports on the cost analysis of open repair and endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms in Japan. We aimed to evaluate the long-term outcomes and cost-effectiveness of these two procedures. This study included patients who underwent open repair (n = 224) and EVAR (n = 87) between January 2012 and December 2022. After propensity score matching, we compared the two groups. The drug and blood products, procedures, and DPC costs were significantly higher in the open repair group (p < 0.001) than in the EVAR group. The surgical equipment and total costs were significantly higher in the EVAR group than in the open repair group (p < 0.001). There was no significant difference in the 5-year survival rate (88.5% in the open repair group vs. 72.0% in the EVAR group; p = 0.33) and freedom from re-intervention rate at 5years (93.1% in the open repair group vs. 89.9% in the EVAR group; p = 0.15) between the two groups. Open repair is more cost-effective than EVAR. The cost-effectiveness of EVAR may therefore depend on the cost of the endograft.

Comparable perioperative mortality outcomes in younger patients undergoing elective open and endovascular abdominal aortic aneurysm repair