Surgical waiting lists and queue management in a Brazilian tertiary public hospital.

BACKGROUND: Centralized management of queues helps to reduce the surgical waiting time in the publicly funded healthcare system, but this is not a reality in the Brazilian Unified Healthcare System (BUHS). We describe the implementation of the "Patients with Surgical Indication" (PSI) in a Brazilian public tertiary hospital, the impact on waiting time, and its use in rationing oncological surgeries during the COVID-19 Pandemic. METHODS: Retrospective observational study of elective surgical requests (2016-2022) in a Brazilian general, public, tertiary university hospital. We recovered information regarding the inflows (indications), outflows and their reasons, the number of patients, and waiting time in queue. RESULTS: We enrolled 82,844 indications in the PSI (2016-2022). The waiting time (median and interquartile range) in days decreased from 98(48;168) in 2016 to 14(3;152) in 2022 (p < 0.01). The same occurred with the backlog that ranged from 6,884 in 2016 to 844 in 2022 (p < 001). During the Pandemic, there was a reduction in the number of non-oncological surgeries per month (95% confidence interval) of -10.9(-18.0;-3.8) during Phase I (January 2019-March 2020), maintenance in Phase II (April 2020-August 2021) 0.1(-10.0;10.4) and increment in Phase III (September 2021-December 2022) of 23.0(15.3;30.8). In the oncological conditions, these numbers were 0.6(-2.1;3.3) for Phase I, an increase of 3.2(0.7;5.6) in Phase II and 3.9(1,4;6,4) in Phase III. CONCLUSION: Implementing a centralized list of surgical indications and developing queue management principles proved feasible, with effective rationing. It unprecedentedly demonstrated the decrease in the median waiting time in Brazil.

Short term outcomes of carotid surgery: the real-world experience of a single teaching center.

Background: Surgical treatment of symptomatic extracranial carotid stenosis is well established for preventing neurological events and should adhere to optimal quality standards. However, there is growing concern as to whether results of controlled trials are replicable in real-world settings. Objectives: To assess a symptomatic carotid stenosis population that underwent surgery and its short-term outcomes in a real-world context at a professional training center. Methods: Observational study using data collected from medical records from January 2012 to January 2023. Patients undergoing operations for other carotid diseases and with concomitant heart surgery were excluded. Results: A total of 70 patients undergoing angioplasty or carotid endarterectomy were included. Population subsets undergoing angioplasty or endarterectomy were similar. Differences in anesthetic modality and a longer operative time in the carotid endarterectomy subgroup were statistically significant. There were 4 cases of stroke, only 3 of which (2 minor and 1 major) were related to the index lesion. Thus, the rate of major operation-related stroke was 1.43% and the rate of any lesion-related stroke was 4.29%. There was 1 case of AMI in the angioplasty group and there were no deaths in the sample. The overall rate of major adverse cardiovascular events was 5.71%. There were no statistical differences between the endarterectomy and angioplasty groups regarding the main outcomes. Conclusions: The rates of outcomes of ischemic stroke, acute myocardial infarction, death, and major adverse cardiovascular events at this center are in line with the rates reported by randomized controlled trials, demonstrating the feasibility of carotid surgery in centers with teaching programs.

Brazilian Angiology and Vascular Surgery Society Guidelines for the treatment of extracranial cerebrovascular disease.

Extracranial cerebrovascular disease has been the subject of intense research throughout the world, and is of paramount importance for vascular surgeons. This guideline, written by the Brazilian Society of Angiology and Vascular Surgery (SBACV), supersedes the 2015 guideline. Non-atherosclerotic carotid artery diseases were not included in this document. The purpose of this guideline is to bring together the most robust evidence in this area in order to help specialists in the treatment decision-making process. The AGREE II methodology and the European Society of Cardiology system were used for recommendations and levels of evidence. The recommendations were graded from I to III, and levels of evidence were classified as A, B, or C. This guideline is divided into 11 chapters dealing with the various aspects of extracranial cerebrovascular disease: diagnosis, treatments and complications, based on up-to-date knowledge and the recommendations proposed by SBACV.

Guidelines on deep vein thrombosis of the Brazilian Society of Angiology and Vascular Surgery.

Deep vein thrombosis is one of the main causes of inpatient and outpatient morbidity, both in medical and surgical patients, significantly impacting mortality statistics and requiring prompt diagnosis so that treatment can be initiated immediately. This document was prepared and reviewed by 11 specialists certified by the Brazilian Society of Angiology and Vascular Surgery, who searched the main databases for the best evidence on the diagnostic (physical examination, imaging) and therapeutic approaches (heparin, coumarins, direct oral anticoagulants, fibrinolytics) to the disease.

Brazilian Society of Angiology and Vascular Surgery 2023 guidelines on the diabetic foot.

The diabetic foot interacts with anatomical, vascular, and neurological factors that challenge clinical practice. This study aimed to compile the primary scientific evidence based on a review of the main guidelines, in addition to articles published on the Embase, Lilacs, and PubMed platforms. The European Society of Cardiology system was used to develop recommendation classes and levels of evidence. The themes were divided into six chapters (Chapter 1 - Prevention of foot ulcers in people with diabetes; Chapter 2 - Pressure relief from foot ulcers in people with diabetes; Chapter 3 -Classifications of diabetic foot ulcers; Chapter 4 - Foot and peripheral artery disease; Chapter 5 - Infection and the diabetic foot; Chapter 6 - Charcot's neuroarthropathy). This version of the Diabetic Foot Guidelines presents essential recommendations for the prevention, diagnosis, treatment, and follow-up of patients with diabetic foot, offering an objective guide for medical practice.

Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.

BACKGROUND: Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. METHODS: In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2-3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684. FINDINGS: From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2-3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12-0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. INTERPRETATION: In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. FUNDING: Bayer.

Adequacy of venous thromboembolism risk stratification and prophylaxis in a tertiary university hospital.

Background: Venous thromboembolism is the third most common cardiovascular disease and the main cause of preventable death in hospitalized patients. Prophylaxis is still underused, despite well-established guidelines in the literature. Studies show a worldwide prophylaxis adequacy rate close to 50%. Objectives: To assess the adequacy of risk stratification and prophylactic measures for venous thromboembolism in a tertiary university hospital. Methods: A cross-sectional observational study was carried out, collecting data from medical records. Adult patients hospitalized by different specialties were enrolled and divided into surgical and clinical groups. The risk stratification of venous thromboembolism performed by the attending physicians was compared with stratification based on recent guidelines performed by the research physicians. Prophylaxis measures prescribed by the attending physicians were compared with guideline recommendations, thus obtaining the prophylaxis adequacy rate. Results: 400 patients were analyzed, 169 (42.3%) surgical and 231 (57.7%) clinical. The overall stratification adequacy rate was 50.8%. Adequacy rates were 39.1% and 59.3% in the surgical and clinical groups respectively (P < 0.0001). The overall prophylaxis adequacy rate was 71.5%, with 78.1% in the surgical group and 66.7% in the clinical group (P=0.0137). Conclusions: Risk stratification adequacy is low, demonstrating a low awareness among prescribing physicians of the need for adequate stratification for prescription of prophylaxis. However, the prophylaxis prescription adequacy rates are higher than those in global data.

Brazilian guidelines on diagnosis and management of traumatic vascular injuries.

Trauma is a leading cause of death, permanent disability, and health care cost worldwide. The young and economically active are the most affected population. Exsanguination due to noncompressible torso hemorrhage is one of the most frequent causes of early death, posing a significant challenge to trauma and vascular surgeons. The possibility of limb loss due to vascular injuries must also be considered. In recent decades, the approach to vascular injuries has been significantly modified. Angiotomography has become the standard method for diagnosis, endovascular techniques are currently incorporated in treatment, and damage control, such as temporary shunts, is now the preferred approach for the patients sustaining physiological derangement. Despite the importance of this topic, few papers in the Brazilian literature have offered guidelines on vascular trauma. The Brazilian Society of Angiology and Vascular Surgery has developed Projetos Diretrizes (Guideline Projects), which includes this publication on vascular trauma. Since treating trauma patients is a multidisciplinary effort, the Brazilian Trauma Society (SBAIT) was invited to participate in this project. Members of both societies reviewed the literature on vascular trauma management and together wrote these guidelines on vascular injuries of neck, thorax, abdomen, and extremities.

Guidelines on vascular access for hemodialysis from the Brazilian Society of Angiology and Vascular Surgery.

Chronic kidney disease is a worldwide public health problem, and end-stage renal disease requires dialysis. Most patients requiring renal replacement therapy have to undergo hemodialysis. Therefore, vascular access is extremely important for the dialysis population, directly affecting the quality of life and the morbidity and mortality of this patient population. Since making, managing and salvaging of vascular accesses falls within the purview of the vascular surgeon, developing guideline to help specialists better manage vascular accesses for hemodialysis if of great importance. Thus, the objective of this guideline is to present a set of recommendations to guide decisions involved in the referral, evaluation, choice, surveillance and management of complications of vascular accesses for hemodialysis.

A doença renal crônica é um problema de saúde pública global e em seu estágio terminal está associada à necessidade de terapia dialítica. A grande maioria dos pacientes que necessitam realizar a terapia renal substitutiva, a fazem através da hemodiálise. Portanto, o acesso vascular é de extrema importância para a população dialítica, implicando diretamente na qualidade de vida e na morbimortalidade deste grupo de pacientes. Sendo a confecção, gerenciamento e resgate dos acessos vasculares uma das áreas de atuação do cirurgião vascular, é de grande importância a elaboração de uma diretriz que oriente o especialista no manejo mais adequado do acesso vascular para hemodiálise. Assim, o objetivo desta diretriz é apresentar um conjunto de recomendações para guiar as decisões na referenciação, avaliação, escolha, vigilância e gestão das complicações do acesso vascular para hemodiálise.

Brazilian guidelines on chronic venous disease of the Brazilian Society of Angiology and Vascular Surgery.

The Brazilian Society of Angiology and Vascular Surgery has set up a committee to provide new evidence-based recommendations for patient care associated with chronic venous insufficiency. Topics were divided in five groups: 1. Classification, 2. Diagnosis, 3. Conservative or non-invasive treatment, 4. Invasive treatment and 5. Treatment of small vessels. This last series is closely related to the activities of Brazilian angiologists and vascular surgeons, who are heavily involved in the treatment of small superficial veins. These guidelines are intended to assist in clinical decision-making for attending physicians and health managers. The decision to follow a guideline recommendation should be made by the responsible physician on a case-by-case basis taking into account the patient's specific condition, as well as local resources, regulations, laws, and clinical practice recommendations.

A Sociedade Brasileira de Angiologia e de Cirurgia Vascular organizou uma comissão para fornecer novas recomendações baseadas em evidências sobre questões críticas de atendimento ao paciente com insuficiência venosa crônica. São abordados aqui os temas de classificação, diagnóstico, tratamento conservador, tratamento invasivo e tratamento de pequenos vasos. Esta última série está muito relacionada à atividade de angiologistas e cirurgiões vasculares, que possuem forte atuação no tratamento de pequenas veias superficiais. Estas diretrizes destinam-se a auxiliar na tomada de decisões clínicas de médicos assistentes e gestores de saúde. A decisão de seguir uma recomendação de diretriz deve ser feita pelo médico responsável caso a caso, levando em consideração a condição específica do paciente, bem como recursos locais, regulamentos, leis e recomendações de prática clínica.

Brazilian Society for Angiology and Vascular Surgery guidelines on abdominal aortic aneurysm.

The Brazilian Society of Angiology and Vascular Surgery, through the Guidelines Project, presents new Abdominal Aortic Aneurysm Guidelines, on the subject of care for abdominal aortic aneurysm patients. Its development prioritized descriptive guidelines, using the EMBASE, LILACS, and PubMed databases. References include randomized controlled trials, systematic reviews, meta-analyses, and cohort studies. Quality of evidence was evaluated by a pair of coordinators, aided by the RoB 2 Cochrane tool and the Newcastle Ottawa Scale forms. The subjects include juxtarenal aneurysms, infected aneurysms, and new therapeutic techniques, especially endovascular procedures. The current version of the guidelines include important recommendations for the primary topics involving diagnosis, treatment, and follow-up for abdominal aortic aneurysm patients, providing an objective guide for medical practice, based on scientific evidence and widely available throughout Brazil.

A Sociedade Brasileira de Angiologia e Cirurgia Vascular, por meio do projeto Diretrizes, apresenta as novas Diretrizes de Aorta Abdominal, referentes aos cuidados de pacientes com aneurisma de aorta abdominal. Para sua elaboração, foram priorizadas diretrizes descritivas, utilizando as bases EMBASE, LILACS e PubMed. As referências incluem ensaios clínicos randomizados, revisões sistemáticas, metanálises e estudos de coorte. A qualidade das evidências foi examinada por uma dupla de coordenadores, com auxílio da ferramenta RoB 2 da Colaboração Cochrane e dos formulários da Newcastle Ottawa Scale. Aneurismas justarrenais, infectados e novas técnicas terapêuticas, principalmente no âmbito endovascular, estão entre os temas estudados. A versão atual das Diretrizes apresenta importantes recomendações para os principais itens que envolvem o diagnóstico, tratamento e acompanhamento de pacientes com aneurisma de aorta abdominal, oferecendo um guia objetivo para prática médica, construído a partir de evidências científicas e amplamente acessível em todo o território nacional.

Short-Term Outcomes of Transfemoral Carotid Artery Stenting and Carotid Endarterectomy in Symptomatic Patients: Data from a Multicentric Prospective Registry in Brazil.

BACKGROUND: Transfemoral carotid artery stenting (TF-CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. Because their main objective is to prevent future ischemic events, regular reassessment of the outcomes is mandatory for providing the best therapy. The purpose of this study was to describe the practice and the outcomes of TF-CAS and CEA in symptomatic patients in public university hospitals in Brazil, using data from a prospective multicentric registry. METHODS: A prospective 8-year observational study of patients with symptomatic carotid artery atherosclerotic disease that underwent TF-CAS and CEA in 5 public university hospitals affiliated with the RHEUNI (Registry Project of Vascular Disease in the Public University Hospitals of São Paulo). All consecutive procedures were included. The indications for the procedures were determined by each surgeon's individual discretion, in accordance with a preoperative risk evaluation. The outcome measures were any 30-day follow-up death, stroke, myocardial infarction (MI), and their combined outcome (major adverse cardiovascular events [MACE]). The registration of the study was made at clinicaltrials.gov NCT02538276. RESULTS: From January 2012 through December 2019, 376 consecutive and symptomatic patients were included in the study records. There were 152 TF-CAS procedures (40.4%) and 224 CEA procedures (59.5%). All completed the 30-day follow-up period. Occurrence of death (TF-CAS: 0.66% × CEA: 0.66%, P = 0.99), stroke (TF-CAS: 4.61% × CEA: 4.46%, P = 0.99), and MI (TF-CAS: 0.66% × CEA: 0%, P = 0.403) were similar in both groups, without statistically significant differences. MACE rate did not differ in both groups (TF-CAS: 5.92% × CEA: 4.46%, P = 0.633). CONCLUSIONS: Data from a prospective registry of 5 Brazilian university hospitals showed that TF-CAS and CEA in symptomatic patients had similar 30-day perioperative rates of death, stroke, and MI and their combination.

Inpatient consultations with the vascular and endovascular surgery team at an academic tertiary hospital.

Background: Inpatient consultations are a fundamental component of practice in tertiary care centers. However, such consultations demand resources, generating a significant workload. Objectives: To investigate the profile of inpatient consultations requested by other specialties and provided by the Vascular and Endovascular Surgery team at an academic tertiary hospital. Methods: Prospective observational study. Results: From May 2017 to May 2018, 223 consultations were provided, representing 2.2% of the workload. Most consultations were requested by Oncology (16.6%), Hematology (9.9%), Nephrology (9.0%), and Cardiology (6.3%). The leading reasons for inpatient consultation were: need for vascular access (51.1%) and requests to evaluate a vascular disease (48.9%). Acute venous diseases accounted for 19.3% of consultations, chronic arterial diseases for 14.8%, acute arterial diseases for 7.2%, diabetic feet for 5.4%, and chronic venous diseases accounted for 2.2%. Surgical treatment was performed in 57.0%, either conventional (43.9%) or endovascular (13.0%). Almost all (98.2%) patients' issues were resolved. Conclusions: Inpatient consultations with the Vascular and Endovascular Surgery team in a tertiary academic hospital accounted for 2.2% of the team's entire workload. Most patients were elective and underwent low-complexity elective surgical procedures. There may be an opportunity to improve healthcare, redirecting these patients to the outpatient flow.

Introdução: Interconsultas são um componente fundamental da prática clínica em centros de atendimento terciários. No entanto, esse tipo de consulta requer recursos, resultando em uma alta carga de trabalho. Objetivo: Investigar o perfil das interconsultas solicitadas por outros departamentos e realizadas pela equipe de Cirurgia Vascular e Endovascular em um hospital universitário terciário. Métodos: Estudo observacional prospectivo. Resultados: De maio de 2017 a maio de 2018, foram realizadas 223 consultas, correspondendo a 2,2% da carga de trabalho. A maioria das consultas foram solicitadas pelos departamentos de Oncologia (16,6%), Hematologia (9,9%), Nefrologia (9,0%) e Cardiologia (6,3%). As principais razões das interconsultas foram a necessidade de acesso vascular (51,1%) e de avaliação de doenças vasculares (48,9%). As doenças venosas agudas corresponderam a 19,3% das avaliações; as doenças arteriais crônicas, a 14,8%; as doenças arteriais agudas, a 7,2%; o pé diabético, a 5,4%; e as doenças venosas crônicas corresponderam a 2,2%. Foi realizado tratamento cirúrgico em 57,0% dos casos, tanto convencional (43,9%) quanto endovascular (13,0%). Foram resolvidos os problemas de quase todos os pacientes (98,2%). Conclusão: As interconsultas realizadas pela equipe de Cirurgia Vascular e Endovascular em um hospital universitário terciário corresponderam a 2,2% da carga de trabalho total. A maioria dos pacientes eram eletivos e foram submetidos a procedimentos cirúrgicos eletivos de baixa complexidade. O redirecionamento desses pacientes para o atendimento ambulatorial poderia auxiliar na melhoria dos serviços de saúde.

Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.

BACKGROUND: The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis. DESIGN: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35 ± 4 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death) up to day 35 ± 4 posthospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria. SUMMARY: The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.1.

Contemporary Management of Arterial Thoracic Outlet Syndrome.

BACKGROUND: Arterial thoracic outlet syndrome (aTOS) is characterized by compression of the subclavian artery as it exits the thoracic girdle. Chronic and repetitive compression leads to several degrees of arterial wall damage. The treatment is varied and depends on the presentation severity. This study aimed to describe the contemporary experience in managing arterial thoracic outlet syndrome at a large tertiary hospital. METHODS: We conducted a single-institution retrospective review of aTOS cases from January 2009 to January 2020. Demographic data, clinical presentation, medical images, operative notes, and outcomes were assessed. RESULTS: Thirteen aTOS cases were identified. The mean age was 43 ± 10 years, and 11 (85%) were women. Both sides were equally affected: right (7 cases, 54%) and left (6 cases, 46%). The most common clinical presentation was arm claudication (7 cases, 54%). Other presentations were: acute arm ischemia, pulsatile neck mass and distal embolization. Cervical ribs were identified by plain X-rays in most cases. All patients were submitted to surgical decompression through the supraclavicular approach. Patients with early disease stages were not submitted to arterial reconstruction and were followed with duplex scan. Arterial reconstruction was done in advanced disease stages (5 cases, 38%): end-to-end anastomosis, interposition graft, and bypass graft. The mean follow-up duration was 32,6 ± 25 months. In all patients, the subclavian artery/graft was patent, and the vascular symptoms were entirely resolved. There were no deaths or amputations. CONCLUSIONS: Arterial thoracic outlet syndrome has a varied clinical presentation. Cervical ribs are the most common anatomic abnormalities. The diagnosis was based on history, physical examination, and imaging exams. Surgery consisted of supraclavicular decompression, arterial resection, and vascular reconstruction, according to the disease stage. The outcomes were excellent.

Surgical treatment of cervical rib-associated arterial thoracic outlet syndrome.

The arterial form of thoracic outlet syndrome is rare and is associated with anatomic anomalies, generally a cervical rib. It has a varied range of manifestations. The aim of this article is to describe two cases with different clinical presentations: microembolization and aneurysm. A cervical rib was present in both cases. Diagnosis was made on the basis of history, physical examination, postural maneuvers, and X-rays. Computed tomography angiography provided the anatomic detail necessary to plan surgery. Surgical treatment was performed via supraclavicular access, successfully, in both cases.

Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial.

BACKGROUND: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. STUDY DESIGN: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. SUMMARY: This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.

Carbon-Coated Stent and the Role of the Kallikrein-Kinin System in Peripheral Angioplasty.

OBJECTIVE: The purpose of this study was to investigate the clinical evolution of patients treated with carbon-coated stent, as well as its patency and the inflammatory response triggered by this process through the quantification of serum elements of the kallikrein-kinin system (KKS). METHODS: This was a single-center prospective study with 27 patients with peripheral artery disease (PAD) who required percutaneous transluminal angioplasty and stenting of the iliacofemoropopliteal segment using carbon-coated stent grafts (carbostents). The blood concentrations of the total and kininogen fractions were evaluated using immunoenzymatic methods. Plasma kallikrein levels were assessed by the colorimetric method and tissue kallikrein levels were evaluated by the spectrophotometric method. The activity of kininase II was measured by -fluorometric analysis. RESULTS: Of the 27 patients who completed the 6 months of the study (11 iliac territory, 16 femoropopliteal territory), only one experienced restenosis (3.7%) (femoropopliteal segment) and no patient had occlusion (96.3% of patency). In 1 year, four patients were lost to follow-up and all 23 patients evaluated maintained stent patency, except for the patient who had restenosis throughout the first 6 months. We report complete (100%) member salvage in 12 months of follow-up. The activity levels of high- and low-molecular-weight kininogens decreased significantly over time (before vs. 24 h, p < 0.01; before vs. 6 months, p < 0.001, and before vs. 24 h, p < 0.01; before vs. 6 months, p < 0.001; 24 h vs. 6 months, p < 0.001, respectively). Patients also had significantly lower levels of plasma and tissue kallikrein (before vs. 24 h, p < 0.001; before vs. 6 months, p < 0.001, and before vs. 24 h, p < 0.01; before vs. 6 months, p < 0.05, respectively). There was a significant increase in the enzymatic activity of kininase II at 24 h and after 6 months compared to the pre-treatment control (p < 0.001). CONCLUSION: Our early experience shows that the use of carbon-coated stents in PAD appears to be safe, with low rates of early restenosis (3.7% in the first 6 months and 5% in the 12 months of follow-up). We concluded that KKS was involved in the inflammatory response caused by the placement of carbon-coated stents.

Endovascular treatment of left internal thoracic artery aneurysm.

Aneurysm of the internal thoracic artery is a rare entity, with variable presentation and a potential risk of fatal rupture. Angiotomography is the diagnostic test of choice and is useful for planning treatment. Considering the morbidity of thoracic access for a direct approach and the unpredictable risk of rupture, an endovascular procedure is the treatment modality of choice for this type of aneurysm. We describe the case of an internal thoracic artery aneurysm discovered incidentally during investigation of syncope and treated by embolization with low-profile and controlled-release microcoils.

Endovascular treatment of bilateral isolated aneurysm of the internal iliac artery.

Isolated aneurysms of the iliac arteries comprise less than 2% of abdominal aneurysms. The internal iliac artery is involved in 10-30% of cases. In most cases patients are asymptomatic, unless rupture occurs. They can be diagnosed by Doppler ultrasonography, magnetic resonance imaging or, preferably, angiotomography. Significant expansion, diameter of 3 cm or greater, and symptomatic cases are indications for surgery. We present the case of a patient with an incidental ultrasonographic finding of bilateral aneurysm of the internal iliac arteries, both with indications for surgery. The patient was successfully treated with endovascular techniques, first repairing the right internal iliac with a branched iliac stent graft, preserving patency, then embolizing the left internal iliac artery. Knowledge of the various different techniques and devices and their limitations is fundamental to adequate planning of endovascular treatment, even in rare cases.