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Short-term survival benefits of endovascular aneurysm repair (EVAR) versus open repair of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is lost after a few years. We investigated whether EVAR had a long-term survival benefit compared with open repair. We used data from the EVAR randomised controlled trial (EVAR trial 1), which enrolled 1252 patients from 37 centres in the UK between Sept 1, 1999, and Aug 31, 2004. Patients had to be aged 60 years or older, have aneurysms of at least 5·5 cm in diameter, and deemed suitable and fit for either EVAR or open repair. Eligible patients were randomly assigned (1:1) using computer-generated sequences of randomly permuted blocks stratified by centre to receive either EVAR (n=626) or open repair (n=626). Patients and treating clinicians were aware of group assignments, no masking was used. The primary analysis compared total and aneurysm-related deaths in groups until mid-2015 in the intention-to-treat population. This trial is registered at ISRCTN (ISRCTN55703451). We recruited 1252 patients between Sept 1, 1999, and Aug 31, 2004. 25 patients (four for mortality outcome) were lost to follow-up by June 30, 2015. Over a mean of 12·7 years (SD 1·5; maximum 15·8 years) of follow-up, we recorded 9·3 deaths per 100 person-years in the EVAR group and 8·9 deaths per 100 person-years in the open-repair group (adjusted hazard ratio [HR] 1·11, 95% CI 0·97–1·27, p=0·14). At 0–6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0·61, 95% CI 0·37–1·02 for total mortality; and 0·47, 0·23–0·93 for aneurysm-related mortality, p=0·031), but beyond 8 years of follow-up open-repair had a significantly lower mortality (adjusted HR 1·25, 95% CI 1·00–1·56, p=0·048 for total mortality; and 5·82, 1·64–20·65, 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 (13 deaths [7%] in EVAR vs two [1%] in open repair), with increased cancer mortality also observed in the EVAR group. EVAR has an early survival benefit but an inferior late survival compared with open repair, which needs to be addressed by lifelong surveillance of EVAR and re-intervention if necessary. UK National Institute for Health Research, Camelia Botnar Arterial Research Foundation.

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.

Abdominal aortic aneurysm is the only cardiovascular disease targeted by population screening. In this study, we test the effect of screening and subsequent intervention for abdominal aortic aneurysm, peripheral arterial disease, and hypertension combined. In this randomised controlled trial, we randomly allocated (1:1) all men aged 65–74 years living in the Central Denmark Region to screening for abdominal aortic aneurysm, peripheral arterial disease, and hypertension, or to no screening. We based allocation on computer-generated random numbers from 1 to 100 in blocks of 1067 to 4392, stratified by 19 municipalities. Only the non-screening group and the investigator assessing outcomes were masked. We invited participants who were found to have abdominal aortic aneurysm or peripheral arterial disease back for confirmation and eventual initiation of relevant pharmacological therapy. We further offered participants with abdominal aortic aneurysm annual control or surgical repair. We referred participants with suspected hypertension to their general practitioner. The primary outcome was all-cause mortality, assessed 5 years after randomisation, analysed in all randomly allocated participants except for those who had incorrect person identification numbers. This trial is registered at ClinicalTrials.gov, number NCT00662480. Between Oct 8, 2008, and Jan 11, 2011, we randomly allocated 50 156 participants, with 25 078 (50%) each in the screening and non-screening groups. Four (<1%) participants in the screening group were lost to follow-up. After a median follow-up of 4·4 years (IQR 3·9–4·8), 2566 (10·2%) of 25 074 participants in the screening group and 2715 (10·8%) of 25 078 in the non-screening group had died. This finding resulted in a significant hazard ratio of 0·93 (95% CI 0·88–0·98; p=0·01), an absolute risk reduction of 0·006 (0·001–0·011), and a number needed to invite of 169 (89–1811). Incidences of diabetes (3995 per 100 000 person-years in the screening group vs 4129 per 100 000 person-years in the non-screening group), intracerebral haemorrhage (146 vs 140), renal failure (612 vs 649), cancer (3578 vs 3719), or 30 day mortality after cardiovascular surgery (44·57 vs 39·33) did not differ between groups. The observed reduction of mortality risk from abdominal aortic aneurysm, peripheral arterial disease, and hypertension has never been seen before in the population screening literature and can be linked primarily to initiation of pharmacological therapy. Health policy makers should consider implementing combined screening whether no screening or isolated abdominal aortic aneurysm screening is currently offered. The 7th European Framework Programme, Central Denmark Region, Viborg Hospital, and the Danish Council for Independent Research.

Abstract BACKGROUND Within randomized clinical trials (RCTs), coiling of the ruptured aneurysm to prevent rebleeding results in better outcomes than clipping in patients with aneurysmal subarachnoid hemorrhage (aSAH). OBJECTIVE To study the association of coiling and clipping with outcome after aSAH in daily clinical practice. METHODS In this controlled, nonrandomized study, we compared outcomes after endovascular coiling and neurosurgical clipping of ruptured intracranial aneurysms in an administrative dataset of 7658 aSAH patients (22 tertiary care hospitals from Europe, USA, Australia; 2007-2013). Because the results contradicted those of the randomized trials, findings were further explored in a large clinical dataset from 2 European centers (2006-2016) of 1501 patients. RESULTS In the administrative dataset, the crude 14-d case-fatality rate was 6.4% (95% confidence interval [CI] 5.6%-7.2%) after clipping and 8.2% (95% CI 7.4%-9.1%) after coiling. After adjustment for age, sex, and comorbidity/severity, the odds ratio (OR) for 14-d case-fatality after coiling compared to clipping was 1.32 (95% CI 1.10-1.58). In the clinical dataset crude 14-d case fatality rate was 5.7% (95% CI 4.2%-7.8%) for clipping and 9.0% (95% CI 7.3%-11.2%) for coiling. In multivariable logistic regression analysis, the OR for 14-d case-fatality after coiling compared to clipping was 1.7 (95% CI 1.1–2.7), for 90-d case-fatality 1.28 (95% CI 0.91–1.82) and for 90-d poor functional outcome 0.78 (95% CI 0.6–1.01). CONCLUSION In clinical practice, coiling after aSAH is associated with higher 14-d case-fatality than clipping and nonsuperior outcomes at 90 d. Both options need to be considered in aSAH patients. Further studies should address the reasons for the discrepancy between current data and those from the RCTs.

Objective This study aims to investigate the clinical manifestations, operative techniques, and outcomes of patients who undergo open repair after thoracic endovascular aortic repair (TEVAR). Methods From January 2010 to June 2022, 113 consecutive type A aortic dissection (TAAD) patients underwent secondary open operation after TEVAR at our institution, and the median interval from primary intervention to open surgery was 12 (1.9–48.0) months. We divided the patients into two groups (RTAD (retrograde type A dissection) group, N  = 56; PNAD (proximal new aortic dissection) group, N  = 57) according to their anatomical features. Survival analysis during the follow-up was evaluated using a Kaplan–Meier survival curve and a log-rank test. Results The 30-day mortality was 6.2% (7/113), the median follow-up period was 31.7 (IQR 14.7–65.6) months, and the overall survival at 1 year, 5 years, and 10 years was 88.5%, 88.5%, and 87.6%, respectively. Fourteen deaths occurred during the follow-up, but there were no late aorta-related deaths. Three patients underwent total thoracoabdominal aortic replacement 1 year after a second open operation. The RTAD group had a smaller ascending aorta size (42.5 ± 7.7 mm vs 48.4 ± 11.4 mm; P  < .01) and a closer proximal landing zone ( P  < .01) compared to the PNAD group. However, there were no differences in survival between the two groups. Conclusions TAAD can present as an early or a late complication after TEVAR due to stent-grafting-related issues or disease progression. Open operation can be performed to treat TAAD, and this has acceptable early and mid-term outcomes. Follow-up should become mandatory for patients after TEVAR because these patients are at increased risk for TAAD.

Purpose: To compare clinical and hemodynamic outcome in patients undergoing treatment of common femoral artery (CFA) atherosclerotic lesions by bioabsorbable stent implantation (BASI group) or by common femoral artery endarterectomy (CFE group). Methods: A randomized, controlled, single-center, open-label trial was initiated to compare outcomes of BASI or CFE in patients with chronic atherosclerotic occlusive lesions in the CFA. From May 2011 to April 2013, 116 consecutive patients were recruited; after excluding 36 patients, 80 patients (52 men; mean age 72.2±9.6 years) were enrolled 1:1 and are the subject of this intention-to-treat interim analysis (40 patients in each group). The primary endpoint was surgical site infections; secondary outcome measures were technical success, hemodynamic improvement, clinical improvement, patency, limb salvage, and survival. Results: There was no statistically significant difference between both groups regarding demographic data, cardiovascular risk factors, or CFA occlusions. The CFE patients presented with 7 surgical site infections (all minor) vs. none in the BASI group (p=0.002) and a longer mean postoperative hospital stay of 7 vs. 2 days for BASI patients (p<0.001). Technical success rates were 97.5% and 100% for the BASI and CFE groups, respectively. Postoperative ankle-brachial index means were comparable (p=0.38). The 30-day primary patency rates were 92.5% and 100% for the BASI and CFE groups, respectively (p=0.038). There were 6 reconstruction failures in CFE patients vs. none in the BASI group (p=0.02); 5 failures involved initial CFA occlusions. At 1 year, the primary and secondary patency rates were 80% vs. 100% (p=0.007) and 84% vs. 100% (p=0.01) for BASI and CFE patients, respectively. Limb salvage was equivalent, and survival rates were 88% and 90% for BASI vs. CFE patients (p=0.51) at 1 year. Conclusion: This interim analysis suggests that BASI is not an option for CFA occlusion and is only a limited option for CFA stenosis. Clinical and hemodynamic results are comparable for BASI and CFE. An increased rate of redo procedures in the BASI patients outweighs lower surgical site infection rates compared to CFE. Short-term patency rates are significantly worse in patients undergoing CFA stenting with BASI.

Background Thoracic aortic pathologies involving the aortic arch are a great challenge for vascular surgeons. Maintaining the patency of supra-aortic branches while excluding the aortic lesion remains difficult. Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations provides a feasible and effective approach for this type of disease. The main purpose of this trial is to assess the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery. Methods This is a prospective, single-center, randomized controlled study. A total of 170 eligible patients will be recruited from The Fourth Affiliated Hospital, Zhejiang University School of Medicine in China and randomized on a 1:1 basis either to the group A (extracorporeal fenestration) or the group B (in situ fenestration). The primary outcome will be the all-cause mortality (30 days). The secondary outcomes will include incidence of secondary intervention (30 days, 6 months, 1 year), incidence of endoleak (30 days, 6 months, 1 year), incidence of major adverse events (MAE) (i.e., immediate procedural success and complications) (30 days, 6 months, 1 year), immediate technical success rate, and all-cause mortality (6 months, 1 year). Discussion Suppose extracorporeal fenestration non-inferior to in situ fenestration in patients with aortic disease involving the left subclavian artery. This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery, which is expected to provide a reference for Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations. Trial registration ClinicalTrials.gov NCT06256757. Registered on February 5, 2024. https://clinicaltrials.gov/study/NCT06256757 .

BackgroundDespite successful reperfusion after thrombectomy for large vessel occlusion (LVO) stroke, up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial (IA) tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.MethodsANGEL-TNK is a multicentre, open-label, assessor-blinded endpoint, prospective randomised, controlled trial that will enrol up to 256 patients. Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.ResultsThe primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale (mRS) 0–1. The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation. Secondary endpoints include 90-day ordinal mRS, mRS 0–2, mRS 0–3, all-cause mortality and any intracranial haemorrhage.ConclusionIn patients with anterior circulation LVO stroke, the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.Trial registration number NCT05624190.

RationaleNeuroprotective strategies based on reperfusion therapy hold substantial promise for acute ischaemic stroke (AIS). Preclinical research indicates that tocilizumab, an interleukin-6 receptor antagonist, can attenuate ischaemia-reperfusion damage by exerting anti-inflammatory and neuroprotective effects.AimTo determine tocilizumab’s efficacy and safety when combined with endovascular thrombectomy (EVT) in patients with acute anterior circulation large vessel occlusion (LVO).Sample size estimatesTo determine a 30% decrease in average infarct core volume comparing the intervention and historical control groups (mean increase of 18.7 mL (SD=9.7 mL) post-thrombectomy) via a two-sided test (alpha=0.05, power=80%), accounting for a 10% drop-out rate, we plan to recruit 108 participants.Methods and designThis trial is designed as a randomised, multicentre, double-blind, placebo-controlled trial. Patients will be randomly and evenly allocated to the tocilizumab or placebo groups.Study outcomesThe primary endpoint is the change in infarct core volume between baseline and 72 hours post-treatment. Secondary outcomes include the 90-day modified Rankin scale score (0–2, indicating functional independence). The key safety endpoints include 90-day mortality and symptomatic intracerebral haemorrhage within 72 hours after EVT.DiscussionAdministering tocilizumab within 24 hours of stroke as an adjunct to EVT may effectively reduce the infarct core volume for patients experiencing AIS with anterior circulation LVO, potentially improving functional outcomes in these patients.

IntroductionAnaemia is common in aneurysmal subarachnoid haemorrhage (aSAH) and is a potential critical modifiable factor affecting secondary injury. Despite physiological evidence and management guidelines that support maintaining a higher haemoglobin level in patients with aSAH, current practice is one of a more restrictive approach to transfusion. The goal of this multicentre pilot trial is to determine the feasibility of successfully conducting a red blood cell (RBC) transfusion trial in adult patients with acute aSAH and anaemia (Hb ≤100 g/L), comparing a liberal transfusion strategy (Hb ≤100 g/L) with a restrictive strategy (Hb ≤80 g/L) on the combined rate of death and severe disability at 12 months.MethodsDesign This is a multicentre open-label randomised controlled pilot trial at 5 academic tertiary care centres. Population We are targeting adult aSAH patients within 14 days of their initial bleed and with anaemia (Hb ≤110 g/L). Randomisation Central computer-generated randomisation, stratified by centre, will be undertaken from the host centre. Randomisation into 1 of the 2 treatment arms will occur when the haemoglobin levels of eligible patients fall to ≤100 g/L. Intervention Patients will be randomly assigned to either a liberal (threshold: Hb ≤100 g/L) or a restrictive transfusion strategy (threshold: Hb ≤80 g/L). Outcome Primary: Centre randomisation rate over the study period. Secondary: (1) transfusion threshold adherence; (2) study RBC transfusion protocol adherence; and (3) outcome assessment including vital status at hospital discharge, modified Rankin Score at 6 and 12 months and Functional Independence Measure and EuroQOL Quality of Life Scale scores at 12 months. Outcome measures will be reported in aggregate.Ethics and disseminationThe study protocol has been approved by the host centre (OHSN-REB 20150433-01H). This study will determine the feasibility of conducting the large pragmatic RCT comparing 2 RBC transfusion strategies examining the effect of a liberal strategy on 12-month outcome following aSAH.Trial registration numberNCT02483351; Pre-results.