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Objective To assess the three year clinical outcomes and cost effectiveness of a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair for patients with suspected ruptured abdominal aortic aneurysm.Design Randomised controlled trial.Setting 30 vascular centres (29 in UK, one in Canada), 2009-16.Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture.Interventions 316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture).Main outcome measures Mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years as secondary measures.Results The maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years. After similar mortality by 90 days, in the mid-term (three months to three years) there were fewer deaths in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90), leading to lower mortality at three years (48% v 56%), but by seven years mortality was about 60% in each group (hazard ratio 0.92, 0.75 to 1.13). Results for the 502 patients with repaired ruptures were more pronounced: three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years there was no clear difference between the groups (hazard ratio 0.86, 0.68 to 1.08). Reintervention rates up to three years were not significantly different between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups. The early higher average quality of life in the endovascular strategy versus open repair group, coupled with the lower mortality at three years, led to a gain in average quality adjusted life years (QALYs) at three years of 0.17 (95% confidence interval 0.00 to 0.33). The endovascular strategy group spent fewer days in hospital and had lower average costs of −£2605 (95% confidence interval −£5966 to £702) (about €2813; $3439). The probability that the endovascular strategy is cost effective was >90% at all levels of willingness to pay for a QALY gain.Conclusions At three years, compared with open repair, an endovascular strategy for suspected ruptured abdominal aortic aneurysm was associated with a survival advantage, a gain in QALYs, similar levels of reintervention, and reduced costs, and this strategy was cost effective. These findings support the increasing use of an endovascular strategy, with wider availability of emergency endovascular repair.Trial registration Current Controlled Trials ISRCTN48334791; ClinicalTrials NCT00746122.

Repair of Abdominal Aortic Aneurysm This clinical trial compared endovascular with open repair of unruptured abdominal aortic aneurysm. An early survival advantage with endovascular repair was not sustained after 3 years. Aneurysm rupture remains a concern with this type of repair. Each year, 40,000 patients in the United States undergo elective procedures to repair abdominal aortic aneurysms. 1 These procedures result in about 1250 perioperative deaths — more than for any other general or vascular surgical procedure, with the exception of colectomy. 2 Endovascular repair was introduced in the 1990s as a less invasive method than traditional open repair. Randomized trials have shown that endovascular repair reduces perioperative mortality, 3 – 5 but in the United Kingdom Endovascular Aneurysm Repair 1 (EVAR 1) trial 3 and the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, 4 this advantage was lost within 2 years owing to excess late deaths . . .

Background Aortic aneurysms, a significant cause of mortality, particularly in individuals aged 55 years and older, have witnessed a transformative shift in treatment strategies with the advent of endovascular surgery. Cydar-EV is an innovative image fusion technology that can augment preoperative planning and surgical guidance of endovascular aneurysm repair (EVAR). The ARIA trial aims to evaluate the efficacy of using Cydar-EV with EVAR procedures to reduce operating time while enhancing procedural precision, patient outcomes, and cost-effectiveness. This paper describes the statistical analysis plan for the study. Methods/design The ARIA trial, a phase III, multi-centre, open-label, two-armed, parallel groups randomised controlled surgical trial, seeks to recruit 340 patients diagnosed with abdominal or thoraco-abdominal aortic aneurysms. Participants are randomly assigned to receive either standard endovascular repair or an endovascular repair assisted by Cydar-EV for planning and surgical guidance. Primary and secondary outcomes are assessed at baseline, 4–12 weeks, and 52 weeks. The primary outcome measure is procedure duration at baseline, while additional secondary outcomes are recorded at various time points and include indicators for technical effectiveness, patient outcomes, procedure efficiency, and cost-effectiveness. We plan to analyse the patient outcome data according to the treatment they received regardless of initial allocation. The statistical analysis plan outlines methods for handling missing data, covariates for adjusted analyses, and planned sensitivity analyses to ensure robust evaluation of treatment effects. Trial registration The trial was registered with the ISRCTN register on 03/12/2021, number ISRCTN13832085.

Background Multiple observational studies have associated metformin prescription with reduced progression of abdominal aortic aneurysm (AAA). The Metformin Aneurysm Trial (MAT) will test whether metformin reduces the risk of AAA rupture-related mortality or requirement for AAA surgery (AAA events) in people with asymptomatic aneurysms. Methods MAT is an international, multi-centre, prospective, parallel-group, randomised, placebo-controlled trial. Participants must have an asymptomatic AAA measuring at least 35 mm in maximum diameter, no diabetes, no contraindication to metformin and no current plans for surgical repair. The double-blind period is preceded by a 6-week, single-blind, active run-in phase in which all potential participants receive metformin. Only patients tolerating metformin by taking at least 80% of allocated medication will enter the trial and be randomised to 1500 mg of metformin XR or an identical placebo. The primary outcome is the proportion of AAA events defined as rupture-related mortality or need for surgical repair. Secondary outcomes include AAA growth, major adverse cardiovascular events and health-related quality of life. In order to test if metformin reduced the risk of AAA events by at least 25%, 616 primary outcome events will be required (power 90%, alpha 0.05). Discussion Currently, there is no drug therapy for AAA. Past trials have found no convincing evidence of the benefit of multiple blood pressure lowering, antibiotics, a mast cell inhibitor, an anti-platelet drug and a lipid-lowering medication on AAA growth. MAT is one of a number of trials now ongoing testing metformin for AAA. MAT, unlike these other trials, is designed to test the effect of metformin on AAA events. The international collaboration needed for MAT will be challenging to achieve given the current COVID-19 pandemic. If this challenge can be overcome, MAT will represent a trial unique within the AAA field in its large size and design. Trial registration Australian Clinical Trials ACTRN12618001707257 . Registered on 16 October 2018

IntroductionThe best lifestyle for small abdominal aortic aneurysms (sAAA) is essential for its conservative management. Physical exercise can improve the cardiopulmonary function of the patients, but it remains unclear which specific type of exercise is most beneficial for individuals with sAAA. The current study was designed to investigate the effect of physician-guided enhanced physical exercise programme on the aorto-cardiac haemodynamic environment, aneurysm sac wall, cardiac function and growth rate of sAAA by multimodality MRI.Methods and analysisAAA MOVE study is a prospective, parallel, equivalence, randomised controlled trial. Eligible individuals will be recruited if they are diagnosed with sAAA (focal dilation of abdominal aorta with maximum diameter <5 cm), without contraindication for MRI scanning, or severe heart failure, or uncontrolled arrhythmia. Participants will be randomly allocated to intervention group (physician-guided enhanced physical exercise programme: mainly aerobic training) and control group (standard clinical care) separately in a 1:1 ratio. The primary outcome is 12-month growth rate of sAAA. The first set of secondary outcomes involve multimodality MRI parameters covering flow haemodynamics, aortic wall inflammation and cardiac function. The other secondary outcome (safety end point) is a composite of exercise-related injury, aneurysm rupture and aneurysm intervention. Follow-up will be conducted at 6 and 12 months after intervention.Ethics and disseminationThis study was approved by the Ethics Committee on Biomedical Research of West China Hospital (approval number: 2023-783) on 16 June 2023. Main findings from the trial will be disseminated through presentations at conferences, peer-reviewed publications and directly pushed to smartphone of participants.Trial registration numberChiCTR2300073334.

Background Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. Methods Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph’s Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume <40%) are randomized to one group receiving standard EVAR and another group receiving EVAR with SE. Follow-up assessments postoperatively, after 30 days, and 6 months involve contrast-enhanced ultrasound scans (CEUS) and after 12 months an additional computed tomography angiography (CTA) scan. The presence of T2EL detected by CEUS or CTA after 12 months is the primary endpoint. Secondary endpoints comprise quality of life (quantified by the SF-36 questionnaire), reintervention rate, occurrence of type I/III endoleak, aortic rupture, death, alteration of aneurysm volume, or diameter. Standardized evaluation of CTA scans happens through a core lab. The study will be terminated after the final follow-up visit of the ultimate patient. Discussion Although preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety. Trial registration ClinicalTrials.gov NCT05665101. Registered on 23 December 2022.

Opposing views have been published on the importance of ultrasound screening for abdominal aortic aneurysms. The Multicentre Aneurysm Screening Study was designed to assess whether or not such screening is beneficial. A population-based sample of men (n=67 800) aged 65–74 years was enrolled, and each individual randomly allocated to either receive an invitation for an abdominal ultrasound scan (invited group, n=33 839) or not (control group, n=33 961). Men in whom abdominal aortic aneurysms (⩾3 cm in diameter) were detected were followed-up with repeat ultrasound scans for a mean of 4·1 years. Surgery was considered on specific criteria (diameter ⩾5·5 cm, expansion ⩾1 cm per year, symptoms). Mortality data were obtained from the Office of National Statistics, and an intention-to-treat analysis was based on cause of death. Quality of life was assessed with four standardised scales. The primary outcome measure was mortality related to abdominal aortic aneurysm. 27 147 of 33 839 (80%) men in the invited group accepted the invitation to screening, and 1333 aneurysms were detected. There were 65 aneurysm-related deaths (absolute risk 0·19%) in the invited group, and 113 (0·33%) in the control group (risk reduction 42%, 95% CI 22–58; p=0·0002), with a 53% reduction (95% CI 30–64) in those who attended screening. 30-day mortality was 6% (24 of 414) after elective surgery for an aneurysm, and 37% (30 of 81) after emergency surgery. Our results provide reliable evidence of benefit from screening for abdominal aortic aneurysms.

Whether clinically stable small abdominal aortic aneurysms should be surgically repaired or monitored with periodic noninvasive imaging is controversial. This study compared the two approaches in patients with aneurysms 4.0 to 5.4 cm in diameter. After a mean follow-up of nearly five years, there was no survival advantage associated with immediate surgical repair. This study compared the two approaches in patients with aneurysms of 4.0 to 5.4 cm. There was no survival advantage with immediate surgical repair. Each year in the United States, 9000 deaths result from rupture of abdominal aortic aneurysms. 1 Another 33,000 patients undergo elective repair of asymptomatic abdominal aortic aneurysms to prevent rupture, which results in 1400 to 2800 operative deaths. 2 , 3 Because most abdominal aortic aneurysms never rupture, 4 elective repair is undertaken only when the risk of rupture is considered high. The strongest known predictor of rupture is the maximal diameter of the aneurysm. 5 , 6 Elective repair has been recommended for patients with aneurysms of 4.0 cm or more in diameter who do not have medical contraindications, 7 although others have advocated the use . . .

Background Abdominal aortic aneurysm (AAA) is a fatal disease due to the tendency to rupture. The drug treatment for small AAA without surgical indications has been controversial. Previous studies showed that high-sensitivity C-reactive protein (hs-CRP) had become a potential biomarker of the disease, and the anti-inflammatory effect of rivaroxaban for AAA had been well established. Thus, we hypothesized that rivaroxaban could control the progression of AAA in patients with hs-CRP elevation. Methods The study is a prospective, open-label, randomized, controlled clinical trial. Sixty subjects are recruited from the General Hospital of Northern Theatre Command of China. Subjects are randomly assigned (1:1) to the intervention arm (rivaroxaban) or control arm (aspirin). The primary efficacy outcome is the level of serum hs-CRP at 6 months. The secondary outcomes include imaging examination (the maximal diameter of AAA, the maximal thickness of mural thrombus, and the length of aneurysm), major adverse cardiovascular and cerebrovascular events (MACCE, including AAA transformation, non-fatal myocardial infarction, acute congestive heart failure, stent thrombosis, ischemia-driven target vessel revascularization, vascular amputation, stroke, cardiovascular death, and all-cause death), and other laboratory tests (troponin T, interleukin 6, D-dimer, and coagulation function). Discussion The BANBOO trial tested the effect of rivaroxaban on the progression of AAA in patients with elevated Hs-CRP for the first time. Trial registration ChiCTR2100051990, ClinicalTrials.gov, registered on 12 October 2021.

Objectives Endovascular aneurysm repair (EVAR) is considered the treatment of choice for abdominal aortic aneurysms with suitable anatomy. In order to improve radiation safety, European Directive (2013/59) requires member states to implement diagnostic reference levels (DRLs) in radio-diagnostic and interventional procedures. This study aimed to determine local DRLs for EVAR across five European centres and identify an interim European DRL, which currently remains unestablished. Methods Retrospective data was collected for 180 standard EVARs performed between January 2014 and July 2015 from five specialist centres in Ireland (n=2) and Italy (n=3). Data capture included: air kerma-area product (P KA ), total air kerma at the reference point (K a,r ), fluoroscopic time (FT), number of acquisitions, frame rate of acquisition, type of acquisition, patient height, weight, and gender. Results The mean values for each site A, B, C, D, and E were: P KA s of 4343 ± 994 μGym 2 , 18,200 ± 2141 μGym 2 , 11,423 ± 1390 μGym 2 , 7796 ± 704 μGym 2 , 31,897 ± 5798 μGym 2 ; FTs of 816 ± 92 s, 950 ± 150 s, 708 ± 70 s, 972 ± 61 s, 827 ± 118 s; and number of acquisitions of 6.72 ± 0.56, 10.38 ± 1.54, 4.74 ± 0.19, 5.64 ± 0.36, 7.28 ± 0.65, respectively. The overall pooled 75th percentile P KA was 15,849 μGym 2 . Conclusion Local reference levels were identified. The pooled data has been used to establish an interim European DRL for EVAR procedures. Key Points • Abdominal endovascular aneurysm repair (EVAR) requires the use of ionising radiation. • EVAR is a minimally invasive procedure for the treatment of abdominal aortic aneurysms. • Diagnostic reference levels (DRLs) are used to monitor patient radiation exposure. • Radiation dose data was collected from five European centres for EVAR procedures. • Local DRLs have been determined and an interim European DRL is proposed.