A Randomised Trial of Endovascular and Open Surgery for Ruptured Abdominal Aortic Aneurysm – Results of a Pilot Study and Lessons Learned for Future Studies

Hinchliffe, Robert J.; Bruijstens, L.; MacSweeney, Shane T.; Braithwaite, B. D.

doi:10.1016/j.ejvs.2006.05.016

Cited by 286 publications

(91 citation statements)

References 13 publications

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“…Like most randomised trials with missing data, it was assumed that, after conditioning on the observed data, the probability of missing data does not depend on the participant's outcome and so the data are 'missing at random'. 16,23 This assumption is usually implausible, for example because participants in relatively poor health may be more likely to be non-responders to questionnaires or demit from routine clinical follow-up. Methodological guidelines recommend that trials undertake sensitivity analysis, which is best informed by elicited expert opinion, to assess whether or not conclusions are robust to alternative assumptions about the missing data.…”

Section: Developing and Validating A 48-hour Mortality Risk Scorementioning

confidence: 99%

“…Unfortunately, half of the data for the Nottingham trial 16 had been lost, but the other three trials agreed to pool their data for an individual patient meta-analysis.…”

Section: Individual Patient Meta-analysis Of the Three Recent Europeamentioning

confidence: 99%

“…This was based on estimated 30-day mortalities of 47% and 21% for participants receiving open repair and EVAR, respectively, 4,14 an estimate of 55% of participants being anatomically suitable for EVAR after CT and an estimate that 5% of both randomised groups would not have a proven diagnosis of ruptured AAA and no 30-day mortality. 16 Hence, the estimated 30-day mortality was 44 Early secondary outcome measures included 24-hour mortality, in-hospital mortality, costs of primary admission, number of reinterventions, time of discharge and the place to which the participant was discharged from the trial hospital after the primary admission. Details of specialist care bed-days, organ support and reinterventions were recorded primarily to inform costs.…”

Section: Trial Outcomesmentioning

confidence: 99%

“…In addition, the in-hospital and 1-year costs of treating ruptured aneurysms by endovascular repair may be up to 40% lower than for treatment by open repair. 15 However, a single centre pilot randomised trial 16 with 32 participants, carried out in Nottingham, UK, showed a 30-day mortality of > 50% for participants treated with either endovascular aneurysm repair (EVAR) or open repair.…”

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: Developing and Validating A 48-hour Mortality Risk Scorementioning

confidence: 99%

“…Unfortunately, half of the data for the Nottingham trial 16 had been lost, but the other three trials agreed to pool their data for an individual patient meta-analysis.…”

Section: Individual Patient Meta-analysis Of the Three Recent Europeamentioning

confidence: 99%

Section: Trial Outcomesmentioning

confidence: 99%

Section: Chapter 1 Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

View full text Add to dashboard Cite

show abstract

“…In patients with ruptured AAA, EVAR appears to offer a decreased operative mortality [1,[5][6][7][8][9][10]. Unfortunately, this information is derived from retrospective studies or case series with little randomized prospective data available, and the available studies may not adequately adjust for selection bias [4,[6][7][8][9][10]14,15]. There is a tendency for more severely unstable patients requiring a faster treatment decision to undergo traditional open repair, and because circulatory shock is a significant prognostic factor, this has been suggested to falsely improve the favorable EVAR results [1,2,4,[6][7][8][9][10][16][17][18].…”

Section: Discussionmentioning

confidence: 99%

Successful use of emergent endovascular aneurysm repair for a ruptured hypotensive abdominal aortic aneurysm

Basile¹,

Fiesseler²,

Shih³

2013

CRCM

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CASE REPORTA 66-year-old man presented to an emergency department with acute abdominal pain. The pain started abruptly and was severe in nature starting several hours before. Just prior to ED arrival, the patient had a brief syncopal episode lasting 1 -2 minutes. He complained of nausea but denied difficulty breathing, chest pain or recent illness. He had a past medical history significant for a myocardial infarction, hypercholesterolemia and hypertension. He denied smoking. His initial vital signs were temperature, 36.4˚C; heart rate, 101 beats per minute; respiratory rate, 18 per minute; and blood pressure, 97/56 mmHg. On physical examination, he appeared pale and in distress. His chest and cardiac examination were unremarkable. His abdomen was protuberant with marked diffuse tenderness and a pulsatile abdominal mass. A bedside ultrasound was immediately obtained that demonstrated a large AAA. Initial laboratory tests revealed a white blood cell count of 19.08 H/nL, hemoglobin of 13.3 g/dL, a creatinine of 1.3 mg/dL, and a troponin-I of 0.099 ng/mL. The remainder of the initial laboratory tests was unremarkable. Shortly after ED arrival the patient's systolic blood pressure decreased to 60 mmHg. With intravenous fluids the systolic blood pressure rose into the 70 -80 mmHg range. The patient remained awake and oriented with these blood pressures.The initial diagnosis was a hemodynamically unstable ruptured abdominal aortic aneurysm in need of acute surgical repair with a high mortality risk. The patient was considered for endovascular aneurysm repair and underwent an emergency CT scan of the abdomen and pelvis to assess eligibility for this procedure. Despite having a blood pressure that was in the 70 -80 mmHg range, the patient remained awake and alert. The patient was accompanied by the vascular surgery team to radiology while the CT scan was performed. The pre-radiology plan was if the patient decompensated during the performance of the CT scan, the vascular team would discontinue the CT scan and immediately take the patient for emergency open operative repair of the AAA.

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Improved Survival After Abdominal Aortic Aneurysm Rupture by Offering Both Open and Endovascular Repair

Wibmer

Schoder²,

Wolff³

et al. 2008

Arch Surg

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A Randomised Trial of Endovascular and Open Surgery for Ruptured Abdominal Aortic Aneurysm – Results of a Pilot Study and Lessons Learned for Future Studies

Abstract: Despite the relative high operative mortality in the EVAR group, these preliminary results show that it is possible to recruit patients to a randomised trial of OAR and EVAR in patients with ruptured AAA. CT scanning does not delay treatment.

Cited by 286 publications

References 13 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

Successful use of emergent endovascular aneurysm repair for a ruptured hypotensive abdominal aortic aneurysm

Improved Survival After Abdominal Aortic Aneurysm Rupture by Offering Both Open and Endovascular Repair

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