SummaryBackgroundStents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.MethodsThe International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470.FindingsThe trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16–2·45, p=0·006). Risks of any stroke (65 vs 35 events; HR 1·92, 1·27–2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0·0197).InterpretationCompletion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.
Resumo A história natural do hematoma intramural (HI) e da úlcera penetrante (UP) é muito variável, já que podem progredir para a formação de aneurisma, ruptura, dissecção, e podem até mesmo regredir, no caso específico do HI. Exames de imagem têm crescente papel no manejo clínico e operatório da UP e do HI. Ao contrário das projeções semelhantes a úlcera, achados de lagos sanguíneos não são relatados nos estudos tomográficos de pacientes com HI. O entendimento das características da imagem e do curso natural de cada uma dessas entidades ajudará clínicos e cirurgiões a identificar os pacientes com maior risco para um mau prognóstico e pode melhorar os desfechos. A fisiopatologia dessas entidades, as controvérsias no que se refere a suas histórias naturais e os fatores prognósticos das imagens tomográficas são discutidos neste artigo.
Os modelos experimentais em animais vêm sendo utilizados em cirurgia vascular há décadas. O desenvolvimento de novas técnicas para tratamento endovascular dos aneurismas requer a criação de bons modelos experimentais para testar esses dispositivos e estudar seu impacto sobre a progressão da doença. Este artigo tem por objetivo revisar os modelos de aneurisma arterial descritos atualmente. Entre os diversos modelos descritos, nenhum reúne todas as características de um modelo ideal de aneurisma. Os modelos em animais de grande porte são adequados para treino, estudo de alterações em parâmetros fisiológicos durante e após a liberação dos dispositivos e integração do mesmo à parede do vaso. Algumas desvantagens significantes incluem dificuldade do manejo, alto custo, difícil manutenção e regulamentações legais, dificultando a disponibilidade de diversas espécies animais. Modelos em animais menores, como os coelhos e camundongos, embora sejam menos caros e de fácil obtenção, não são adequados para estudos de técnicas endovasculares pelas pequenas dimensões de seus vasos. Nenhum modelo descrito até o momento consegue reproduzir todas as características dos aneurismas observados em humanos. Modelos disponíveis são descritos nesta revisão, e suas vantagens e desvantagens são discutidas.
IMPORTANCE Sodium glucose cotransporter 2 inhibitors reduce morbidity and mortality in patients with heart failure and reduced ejection fraction (HFrEF). Clinicians may find estimates of the projected long-term benefits of sodium glucose cotransporter 2 inhibitors a helpful addition to clinical trial results when communicating the benefits of this class of drug to patients. OBJECTIVE To estimate the projected long-term treatment effects of dapagliflozin in patients with HFrEF over the duration of a patient's lifetime.DESIGN, SETTING, AND PARTICIPANTS Exploratory analysis was performed of Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF), a phase 3 randomized, placebo-controlled clinical trial conducted at 410 sites in 20 countries. Patients with an ejection fraction less than or equal to 40% in New York Heart Association functional classification II to IV and elevated plasma levels of N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019. Mean (SD) duration of follow-up was 17.6 (5.2) months.INTERVENTIONS Dapagliflozin, 10 mg, once daily vs placebo in addition to standard therapy. MAIN OUTCOMES AND MEASURESThe primary composite outcome was time to first hospitalization for heart failure, urgent heart failure visit requiring intravenous therapy, or cardiovascular death. The trial results were extrapolated to estimate the projected long-term treatment effects of dapagliflozin over the duration of a patient's lifetime for the primary outcome and the secondary outcome of death from any cause.RESULTS A total of 4744 patients (1109 women [23.4%]; 3635 men [76.6%]) were randomized in DAPA-HF, with a mean (SD) age of 66.3 (10.9) years. The extrapolated mean event-free survival for an individual aged 65 years from a primary composite end point event was 6.2 years for placebo and 8.3 years for dapagliflozin, representing an event-free survival time gain of 2.1 years (95% CI, 0.8-3.3 years; P = .002). When considering death from any cause, mean extrapolated life expectancy for an individual aged 65 years was 9.1 years for placebo and 10.8 years for dapagliflozin, with a gain in survival of 1.7 years (95% CI, 0.1-3.3; P = .03) with dapagliflozin. Similar results were seen when extrapolated across the age range studied. In analyses of subgroups of patients in DAPA-HF, consistent benefits were seen with dapagliflozin on both event-free and overall survival. CONCLUSIONS AND RELEVANCEThese findings indicate that dapagliflozin provides clinically meaningful gains in extrapolated event-free and overall survival. These findings may be helpful in communicating the benefits of this treatment to patients with HFrEF.TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03036124
curto prazo de "stents" não recobertos e recobertos com politetrafluoroetileno em aorta de suínos: um modelo experimental. Acta Cir Bras [serial online] 2004 Mar-Abr;19(2). Disponível em URL: http://www.scielo.br/acb. RESUMO -Objetivo: Descrever um estudo experimental avaliando através da morfometria digital o espessamento intimal na parede arterial após o implante de "stents" metálicos auto-expansíveis recobertos ou não com politetrafluoroetileno (PTFE) na aorta de suínos. Métodos: Em três grupos de suínos jovens uma bainha introdutora de 12 F foi inserida na aorta abdominal distal. Os animais do grupo I (n=5) foram considerados controle. Os animais do grupo II (n=10) receberam o implante de um stent metálico auto-expansível não recoberto. No grupo III (n=10) um stent auto-expansível recoberto com PTFE foi inserido. Após quatro semanas os animais foram sacrificados e os espécimes arteriais foram retirados, sendo o espessamento intimal quantificado pela análise morfométrica. Resultados: Na comparação entre os grupos I, II e III quanto às áreas da íntima, média e índice intimal, não foi observada variação estatisticamente significativa. Diferenças foram observadas entre os grupos em relação às áreas luminais proximais (p=0,0036) e distais (p=0,044). Através dos testes de comparação múltipla para Kruskal-Wallis foi identificada uma diferença entre os grupos I e II. Entretanto, quando essas variáveis foram controladas pelo fator peso (relação área luminal/peso), a diferença não foi mais observada. Conclusões: Nesse estudo a curto prazo, o revestimento de PTFE não esteve associado a adicional espessamento intimal além daquele promovido pelo dispositivo metálico em artérias de grande calibre e condições de alto fluxo.
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