Protocol for the Metformin Aneurysm Trial (MAT): a placebo-controlled randomised trial testing whether metformin reduces the risk of serious complications of abdominal aortic aneurysm.

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.

[Abdominal aortic aneurysm ultrasound screening in men with risk factors in Primary Care]. / Cribado mediante ecografía de aneurisma de aorta abdominal en varones con factores de riesgo en Atención Primaria.

OBJECTIVE: to describe the implantation of ultrasound screening for Abdominal Aortic Aneurysm (AAA) in our healthcare district in men from 65 to 79 years of age who have had an identifiable risk factor for developing AAA, such as smoking or a history thereof, hypertension, family history of aneurysms, aneurysms in other locations and clinical atherosclerosis, acute myocardial infarction, intermittent claudication, or stroke. Analyse the performance of said screening. SETTING: Primary Care. PARTICIPANTS AND INTERVENTIONS: 656 patients were screened, representing 40% of the target population of 1,658 patients. The remaining part of the target population could not be screened because of the outbreak of the COVID-19 pandemic. 608 ultrasound examinations were performed. MAIN MEASUREMENTS: coverage of the screening programme, prevalence of abdominal aortic aneurysms, prevalence of smoking and other risk factors in patients with/without aneurysms. RESULTS: 19 patients with ectatic aorta (25-29mm) and 11 with abdominal aortic aneurysms (1.81%) were found. 5 were active smokers (45%, compared to 20% in the entire sample) and 6 were former smokers. None of the aneurysm patients were non-smokers. 7 of them were hypertensive. CONCLUSIONS: The prevalence of aneurysms in our sample was 2.6%, which was lower than expected. The wide use of ultrasound and its progressive generalisation in the Primary Care setting should lead to a decrease in the number of undiagnosed AAA.

Results of Transarterial Embolization for Treating Type 2 Endoleaks: A Single-Center Experience.

BACKGROUND: Type 2 endoleaks (T2Es) are the main cause of reintervention after endovascular repair of abdominal aortic aneurysms (EVAR). The objective of this study is to quantify success rates of T2E treatment. METHODS: This study involves a retrospective analysis of a prospectively maintained database containing data on all consecutive patients treated for a T2E between 2003 and 2017 in a single center. Technical success was defined as absence of endoleak in the final angiographic control after treatment. Clinical success was defined as absence of sac growth over 5 mm in the contrast-enhanced computed tomography performed a year thereafter. Statistics included Kaplan-Meier survival estimates. RESULTS: A total of 528 elective EVARs were performed in the period. Thirty-six of these (6.8%) developed a T2E requiring reintervention, a median of 37.9 months after EVAR. Twenty-five percent of the treatments were performed more than 5 years after intervention. Twenty-eight of the 36 treatments were performed via transarterial embolization. For this technique, technical success was 71.4% and clinical success was 62.5%. A subsequent reintervention was required in 35.7% of patients. In this cohort, the rate of aneurysm rupture was 10.7% (n = 3/28), open surgical conversion was needed in 2 of 28 cases (7.1%), and rate of aneurysm-related death was 14.3% (n = 4/28) over follow-up. CONCLUSIONS: A high percentage of patients are at risk of adverse outcomes after T2E treatment. Strict imaging follow-up is still needed in this population.

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair.

BACKGROUND: Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200-220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe. METHODS: Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200-220 s. If the ACT after 5 min is < 180 s, 60 IU/kg will be administered; if the ACT is between 180 and 200 s, 30 IU/kg. If the ACT is > 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group. DISCUSSION: The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. TRIAL REGISTRATION {2A}: NTR NL8421 ClinicalTrials.gov NCT04061798 . Registered on 20 August 2019 EudraCT 2018-003393-27 TRIAL REGISTRATION: DATA SET {2B}: Data category Information Primary registry and trial identifying number ClinicalTrials.gov : NCT04061798 Date of registration in primary registry 20-08-2019 Secondary identifying numbers NTR: NL8421 EudraCT: 2018-003393-27 Source(s) of monetary or material support ZonMw: The Netherlands Organisation for Health Research and Development Dijklander Ziekenhuis Amsterdam UMC Primary sponsor Dijklander Ziekenhuis Secondary sponsor(s) N/A Contact for public queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Contact for scientific queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Public title ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair (ACTION-1) Scientific title ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial Countries of recruitment The Netherlands. Soon the recruitment will start in Germany Health condition(s) or problem(s) studied Abdominal aortic aneurysm, arterial disease, surgery Intervention(s) ACT-guided heparinization 5000 IU of heparin Key inclusion and exclusion criteria Ages eligible for the study: ≥18 years Sexes eligible for the study: both Accepts healthy volunteers: no Inclusion criteria: Study type Interventional Allocation: randomized Intervention model: parallel assignment Masking: single blind (patient) Primary purpose: treatment Phase IV Date of first enrolment March 2020 Target sample size 750 Recruitment status Recruiting Primary outcome(s) The primary efficacy endpoint is 30-day mortality and in-hospital mortality during the same admission. The primary safety endpoint is the incidence of bleeding complications according to E-CABG classification, grade 1 and higher. Key secondary outcomes Serious complications as depicted in the Suggested Standards for Reports on Aneurysmal disease: all complications requiring re-operation, longer hospital stay, all complications.

Systemic Thrombolysis as Initial Treatment of COVID-19 Associated Acute Aortoiliac and Lower Extremity Arterial Thrombosis.

SARS-CoV-2 (COVID-19) patients with associated thromboembolic events have demonstrated poor outcomes despite the use of anticoagulation therapy and surgical intervention. We present a COVID-19 patient with acute limb ischemia, secondary to extensive thrombosis of an aortic aneurysm, iliac arteries, and infrainguinal arteries. Initial treatment with systemic thrombolysis, which restored patency of the aortoiliac occlusion, was followed by open thrombectomies of the infrainguinal occlusions.

Ruptured Abdominal Aortic Aneurysm Treated with Endovascular Repair in a Patient with Active COVID-19 Infection during the Pandemic.

We report a patient who presented with acute abdominal pain during the COVID-19 pandemic. His work-up revealed rupture of a 5.8 cm abdominal aortic aneurysm. He also had fever, cough, and shortness of breath and radiologic evidence of COVID-19 infection. After careful consideration, he underwent successful endovascular repair under local anesthesia with good short-term results.