RESUMO
BACKGROUND Whether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown. METHODS AND RESULTS This study included 4018 patients with acute coronary syndrome recruited in the ISAR-REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial. The primary end point was a composite of all-cause death, myocardial infarction, or stroke. Overall, 3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients). Patients recruited in the LRCs had more favorable cardiovascular risk profiles than patients recruited in the HRCs. The primary end point occurred in 72 patients in the LRCs and 249 patients in the HRCs (cumulative incidence, 7.3% and 8.4%; P=0.267). All-cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%; P=0.031). There was no significant interaction between the treatment effect of ticagrelor versus prasugrel and patient recruitment category (LRC versus HRC) regarding the primary efficacy end point (LRC: hazard ratio [HR], 1.42 [95% CI, 0.89-2.28]; HRC: HR, 1.33 [95% CI, 1.04-1.72]; P for interaction=0.800). CONCLUSIONS Patients with acute coronary syndrome recruited in a LRC appear to have more favorable cardiovascular risk profiles and lower 1-year mortality rates compared with patients recruited in a HRC. The recruitment volume did not interact with the treatment effect of ticagrelor versus prasugrel. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.
Assuntos
Síndrome Coronariana Aguda , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/tratamento farmacológico , Humanos , Seleção de Pacientes , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Ticagrelor/efeitos adversos , Resultado do TratamentoAssuntos
Pesquisa Biomédica/tendências , Cardiologia/tendências , Equidade de Gênero , Médicas/tendências , Pesquisadores/tendências , Sexismo , Autoria , Políticas Editoriais , Feminino , Humanos , Masculino , Revisão da Pesquisa por Pares/tendências , Publicações Periódicas como Assunto/tendências , Sociedades Médicas/tendênciasRESUMO
To date, there have been no studies comparing flat-knit and round-knit compression garments for maintenance therapy of lymphedema of the leg. According to expert opinion, flat-knit fabrics are generally recommended for this purpose. Given the differences in the clinical presentation of lymphedema in terms of disease stage and location as well as patient adherence, and, last but not least, for economic reasons, it seems questionable whether all patients with lymphedema of the leg actually do require flat-knit compression garments. Considering technical aspects, published data and our own clinical experience, it seems reasonable that the choice of compression stockings be based on clinical findings and not on the diagnosis. Typical indications for flat-knit garments include significant differences in leg circumference as well as deep skin folds and edema of the toes/forefoot. However, there are also patients with lymphedema who benefit from round-knit fabrics with a high degree of stiffness. In any case, prior to maintenance therapy, it is essential to adequately decongest the legs using compression bandages and/or adaptive compression systems.
Assuntos
Vestuário/efeitos adversos , Bandagens Compressivas/efeitos adversos , Edema/patologia , Linfedema/terapia , Meias de Compressão/efeitos adversos , Bandagens Compressivas/economia , Elasticidade , Desenho de Equipamento , Feminino , Pé/patologia , Humanos , Perna (Membro)/anatomia & histologia , Perna (Membro)/patologia , Linfedema/complicações , Pessoa de Meia-Idade , Cooperação do Paciente , Dobras Cutâneas , Meias de Compressão/economiaRESUMO
BACKGROUND: Whether there are sex differences in the outcome of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) remains controversial. We undertook this study to assess whether there are sex-related differences in the long-term mortality in a large series of patients with CAD after PCI. METHODS: The study included 18,334 patients (4735 women and 13,599 men) with CAD treated with PCI. Propensity matching was performed to obtain a group of patients (3000 women and 3000 men) matched for all characteristics available in database. The primary outcome was a composite of cardiac mortality, myocardial infarction or stroke at 3â¯years of follow-up. RESULTS: The primary outcome occurred in 660 women and 1440 men (Kaplan-Meier [KM] estimates, 15.2% in women and 11.6% in men, unadjusted hazard ratio [HR]â¯=â¯1.35, 95% confidence interval [CI] 1.24 to 1.49; Pâ¯<â¯0.001). Women were at higher risk of all-cause mortality (15.4% vs. 12.3%; Pâ¯<â¯0.001), cardiac mortality (10.2% vs. 7.6%; Pâ¯<â¯0.001) and stroke (2.6% vs. 1.4%; Pâ¯<â¯0.001) than men. In matched patients, the primary outcome occurred in 371 women and 322 men (KM estimates, 13.4% vs. 11.6%, HRâ¯=â¯1.18 [1.01-1.36], Pâ¯=â¯0.033). Women were at higher risk of myocardial infarction (4.2% vs. 3.1%; Pâ¯=â¯0.044) but not cardiac (8.7% vs. 8.2%; Pâ¯=â¯0.306) or all-cause death (12.5% vs. 12.9%; Pâ¯=â¯0.991) or stroke (1.9% vs. 1.6%; Pâ¯=â¯0.550) than men. CONCLUSIONS: After propensity matching, women remained at a higher risk of a composite of cardiac mortality, myocardial infarction or stroke up to 3â¯years after PCI than men.