Endovascular Repair Versus Open Repair of Ruptured Abdominal Aortic Aneurysms

Reimerink, J.J.; Hoornweg, L.L.; Vahl, A.C.; Wisselink, Willem; Broek, Ted A. A. van den; Legemate, Dink A.; Reekers, Jim A.; Balm, Ron

doi:10.1097/sla.0b013e31828d4b76

Cited by 308 publications

(108 citation statements)

References 26 publications

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“…The timing of death was assessed from randomisation (for the IMPROVE trial) and from hospital admission (for the AJAX 19 and ECAR 22 trials). Logistic regression analysis was used to estimate the OR of both 30-and 90-day mortality for endovascular repair (or endovascular strategy) compared with open repair, adjusting for trial to obtain a one-stage fixed-effect pooled estimate.…”

Section: Discussionmentioning

confidence: 99%

“…8. Conduct an individual patient meta-analysis of participants randomised in all of the European randomised trials [Amsterdam Acute Aneurysm trial (AJAX), 19 Endovasculaire versus Chirurgie dans les Anévrysmes Rompus (ECAR) 22 and IMPROVE 23 ], with respect to common 30-day and 1-year outcomes. 9.…”

Section: Objectives Of the Improve Trialmentioning

confidence: 99%

“…Later, in 2010, the trial was extended to include 120 participants; the results were finally reported in late 2013. 19 A trial 20 with a similar design started in France in 2008, with the aim of recruiting 160 participants, but it used the rather weak methodology of randomising participants by week of the year. 21 the last European trial to start, larger than all of the other trials combined, had a non-selective recruitment policy for participants with the clinical diagnosis of ruptured aneurysm, so that health policy implications could be addressed.…”

Section: Chapter 1 Introductionmentioning

confidence: 99%

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Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Ulug

Hinchliffe

Sweeting

et al. 2018

Health Technol Assess

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Background Ruptured abdominal aortic aneurysm (AAA) is a common vascular emergency. The mortality from emergency endovascular repair may be much lower than the 40–50% reported for open surgery. Objective To assess whether or not a strategy of endovascular repair compared with open repair reduces 30-day and mid-term mortality (including costs and cost-effectiveness) among patients with a suspected ruptured AAA. Design Randomised controlled trial, with computer-generated telephone randomisation of participants in a 1 : 1 ratio, using variable block size, stratified by centre and without blinding. Setting Vascular centres in the UK (n = 29) and Canada (n = 1) between 2009 and 2013. Participants A total of 613 eligible participants (480 men) with a ruptured aneurysm, clinically diagnosed at the trial centre. Interventions A total of 316 participants were randomised to the endovascular strategy group (immediate computerised tomography followed by endovascular repair if anatomically suitable or, if not suitable, open repair) and 297 were randomised to the open repair group (computerised tomography optional). Main outcome measures The primary outcome measure was 30-day mortality, with 30-day reinterventions, costs and disposal as early secondary outcome measures. Later outcome measures included 1- and 3-year mortality, reinterventions, quality of life (QoL) and cost-effectiveness. Results The 30-day mortality was 35.4% in the endovascular strategy group and 37.4% in the open repair group [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.66 to 1.28; p = 0.62, and, after adjustment for age, sex and Hardman index, OR 0.94, 95% CI 0.67 to 1.33]. The endovascular strategy appeared to be more effective in women than in men (interaction test p = 0.02). More discharges in the endovascular strategy group (94%) than in the open repair group (77%) were directly to home (p < 0.001). Average 30-day costs were similar between groups, with the mean difference in costs being –£1186 (95% CI –£2997 to £625), favouring the endovascular strategy group. After 1 year, survival and reintervention rates were similar in the two groups, QoL (at both 3 and 12 months) was higher in the endovascular strategy group and the mean cost difference was –£2329 (95% CI –£5489 to £922). At 3 years, mortality was 48% and 56% in the endovascular strategy group and open repair group, respectively (OR 0.73, 95% CI 0.53 to 1.00; p = 0.053), with a stronger benefit for the endovascular strategy in the subgroup of 502 participants in whom repair was started for a proven rupture (OR 0.62, 95% CI 0.43 to 0.89; p = 0.009), whereas aneurysm-related reintervention rates were non-significantly higher in this group. At 3 years, considering all participants, there was a mean difference of 0.174 quality-adjusted life-years (QALYs) (95% CI 0.002 to 0.353 QALYs) and, among the endovascular strategy group, a cost difference of –£2605 (95% CI –£5966 to £702), leading to 88% of estimates in the cost-effectiveness plane being in the quadrant showing the endovascular strategy to be ‘dominant’. Limitations Because of the pragmatic design of this trial, 33 participants in the endovascular strategy group and 26 in the open repair group breached randomisation allocation. Conclusions The endovascular strategy was not associated with a significant reduction in either 30-day mortality or cost but was associated with faster participant recovery. By 3 years, the endovascular strategy showed a survival and QALY gain and was highly likely to be cost-effective. Future research could include improving resuscitation for older persons with circulatory collapse, the impact of local anaesthesia and emergency consent procedures. Trial registration Current Controlled Trials ISRCTN48334791 and NCT00746122. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 31. See the NIHR Journals Library website for further project information.

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Section: Discussionmentioning

confidence: 99%

Section: Objectives Of the Improve Trialmentioning

confidence: 99%

Section: Chapter 1 Introductionmentioning

confidence: 99%

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Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Ulug

Hinchliffe

Sweeting

et al. 2018

Health Technol Assess

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“…Three randomised trials including a total of 761 patients were identifi ed, with 388 patients randomised for EVAR and 373 patients with open surgical repair. While Hinchliff e et al [3] focused only on 30-day outcomes, the AJAX [4] and IMPROVE [5] trials also aimed at longer outcomes, although no long-term data from IMPROVE have been published to date. In summary, there was no diff erence regarding in-hospital or 30-day mortality between EVAR and surgery (OR 0.91, 95 % CI 0.67 to 1.22), as well as for in-hospital stroke (OR 0.71, 95 % CI 0.12 to 4.31) and cardiac complications (OR 1.12, 95 % CI 0.38 to 3.30).…”

Section: Evar In Ruptured Abdominal Aneurysmsmentioning

confidence: 99%

“…Acute re-operation rate was also not diff erent between the two approaches (OR 0.89, 95 % CI 0.39 to 2.01). The AJAX trial [4] was the only study which evaluated spinal cord ischaemia and found no diff erences (OR 3.16, 95 % CI 0.13 -79.17). The IMPROVE trial [5] (performed in the United Kingdom) assessed costs at 30 days but did not fi nd a signifi cant diff erence (13,433 GBP after EVAR compared to 14,619 GBP after open repair).…”

Section: Evar In Ruptured Abdominal Aneurysmsmentioning

confidence: 99%

Endovascular or open repair of ruptured abdominal aortic aneurysms

Reinecke

Donas

2016

Vasa

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Endovascular repair of abdominal aortic aneurysms (EVAR) is a fascinating technology because it is minimally invasive but allows the treatment of even complex anatomical conditions. This has led to the fact that 75 % of all abdominal aortic aneurysms (AAA) were treated by EVAR [1]. A number of studies compared the outcomes after elective EVAR and surgery in patients with non-ruptured AAA, as recently shown in the Medicare database [1] with 40,000 propensity-score matched cases. In summary, a signifi cantly reduced in-hospital morbidity and mortality in favour of EVAR during the fi rst 2 to 3 years after intervention was found, but a higher rate of re-operations and ruptured AAA occurred after EVAR [1]. Although a fi nal conclusion could defi nitely not be drawn yet in elective cases, it has been assumed that the benefi ts of EVAR must become even more obvious in patients with ruptured AAA. This subgroup of patients is usually in a critical clinical condition, suff ering from a high early mortality of about 60 -80 % [1,2]. Therefore, a less invasive procedure should result in more favourable outcomes. EVAR in ruptured abdominal aneurysmsA recent meta-analysis [2] screened for all randomised controlled trials comparing EVAR to open repair in ruptured AAA using the Cochrane central register. Most studies were retrospective case-nested control studies (n = 10) or prospective observational studies (n = 5). Three randomised trials including a total of 761 patients were identifi ed, with 388 patients randomised for EVAR and 373 patients with open surgical repair. While Hinchliff e et al. [3] focused only on 30-day outcomes, the AJAX [4] and IMPROVE [5] trials also aimed at longer outcomes, although no long-term data from IMPROVE have been published to date. In summary, there was no diff erence regarding in-hospital or 30-day mortality between EVAR and surgery (OR 0.91, 95 % CI 0.67 to 1.22), as well as for in-hospital stroke (OR 0.71, 95 % CI 0.12 to 4.31) and cardiac complications (OR 1.12, 95 % CI 0.38 to 3.30). Also, postoperative renal failure (OR 0.7, 95 % CI 0.09 to 5.24) and bowel ischemia (OR 0.39, 95 % 0.07 to 2.11) were similar. Acute re-operation rate was also not diff erent between the two approaches (OR 0.89, 95 % CI 0.39 to 2.01). The AJAX trial [4] was the only study which evaluated spinal cord ischaemia and found no diff erences (OR 3.16,). The IMPROVE trial [5] (performed in the United Kingdom) assessed costs at 30 days but did not fi nd a signifi cant diff erence (13,433 GBP after EVAR compared to 14,619 GBP after open repair). However, this strongly depends on the national reimbursement systems and could not be extrapolated to other countries. Finally, only the AJAX trial reported 6 month results, also showing no benefi t for either of the 2 treatments regarding mortality (OR 0.89, 95 % CI 0.40 to 1.98) and re-operation rates (OR 1.28, 95 % CI 0.53 to 3.06). Consequences for daily routineAlthough several of the previous retrospective studies have reported a benefi t regarding major outcomes after EVA...

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Sex Differences in Outcomes Following Ruptured Abdominal Aortic Aneurysm Repair

Eisenberg

Witheford

et al. 2022

JAMA Netw Open

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IMPORTANCE Sex differences in aortic surgery outcomes are commonly reported. However, data on ruptured abdominal aortic aneurysm (rAAA) repair outcomes in women vs men are limited. OBJECTIVE To assess differences in perioperative and long-term mortality following rAAA repair in women vs men. DESIGN, SETTING, AND PARTICIPANTSA multicenter, retrospective cohort study was conducted using the Vascular Quality Initiative database, which prospectively captures information on patients who undergo vascular surgery across 796 academic and community hospitals in North America. All patients who underwent endovascular or open rAAA repair between January 1, 2003, and December 31, 2019, were included. Outcomes were assessed up to January 1, 2020. EXPOSURES Patient sex.MAIN OUTCOMES AND MEASURES Demographic, clinical, and procedural characteristics were recorded, and differences between women vs men were assessed using independent t test and χ 2 test. The primary outcomes were in-hospital and 8-year mortality. Associations between sex and outcomes were analyzed using univariable and multivariable logistic regression and Cox proportional hazards regression analysis. RESULTSA total of 1160 (21.9%) women and 4148 (78.1%) men underwent rAAA repair during the study period. There was a similar proportion of endovascular repairs in women and men (65456.4%] vs 2386 [57.5%]). Women were older (mean [SD] age, 75.8 [9.3] vs 71.7 [9.6] years), more likely to have chronic kidney disease (718 [61.9%] vs 2184 [52.7%]), and presented with ruptured aneurysms of smaller diameters (mean [SD] 68 [18.2] vs 78 [30.2] mm). In-hospital mortality was higher in women (34.4% vs 26.6%; odds ratio, 1.44; 95% CI, 1.25-1.66), which persisted after adjusting for demographic, clinical, and procedural characteristics (adjusted odds ratio, 1.36; 95% CI, 1.12-1.66; P = .002). Eight-year survival was lower in women (36.7% vs 49.5%; hazard ratio, 1.25; 95% CI, 1.04-1.50; P = .02), which persisted when stratified by endovascular and open repair. This survival difference existed in both the US and Canada. Variables associated with long-term mortality in women included older age and chronic kidney disease. CONCLUSIONS AND RELEVANCEWomen who underwent rAAA repair had higher perioperative and 8-year mortality rates following both endovascular and open repair compared with men. Older age and higher rates of chronic kidney disease in women were associated with higher mortality rates. These findings suggest that future studies should assess the reasons for these disparities and whether opportunities exist to improve AAA care for women.

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Endovascular Repair Versus Open Repair of Ruptured Abdominal Aortic Aneurysms

Cited by 308 publications

References 26 publications

Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT

Endovascular or open repair of ruptured abdominal aortic aneurysms

Sex Differences in Outcomes Following Ruptured Abdominal Aortic Aneurysm Repair

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