Does the RYGB common limb length influence hypertension remission and cardiometabolic risk factors? Data from the GATEWAY trial.

BACKGROUND: Although Roux-en-Y gastric bypass (RYGB) results in significant weight loss and cardiometabolic risk factors improvements; there is no consensus whether limb lengths may influence these results. OBJECTIVE: To evaluate the correlations between the common limb length (CLL) and hypertension remission rate, cardiometabolic risk factors, and nutritional parameters after RYGB. SETTINGS: Private Hospital, Brazil. METHODS: GATEWAY is a randomized trial designed to evaluate the efficacy of RYGB on hypertension improvement and other cardiometabolic risk factors in patients with grade I and II obesity compared with medical therapy. The follow-up was 1 year. We measured the entire bowel in all patients and used a 150-cm alimentary limb and a 100-cm biliopancreatic limb. Univariate logistic regression was used to estimate the relationship between CLL and hypertension remission. Pearson and Spearman correlation were used to evaluate the correlation between the CLL and the percentage changes of cardiometabolic risk factors and nutritional parameters. RESULTS: From 100 randomized patients, 45 were submitted to RYGB and completed the follow-up. Mean CLL was 466.3 ± 86.4 cm. Of patients, 55.6% from the RYGB group showed remission of hypertension. CLL length was not significantly associated with hypertension remission (odds ratio [95% confidence interval] for 50 units increase in CLL: .97 [.68; 1.38], P = .88). Consistently, we found no correlations between CLL and all changes in cardiometabolic risk factors and nutritional parameters. CONCLUSIONS: In a proximal RYGB, CLL does not influence hypertension remission, cardiometabolic risk factors, and nutritional parameters.

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: clinicaltrials.gov Identifier: NCT01448642.

Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension).

BACKGROUND: Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed. METHODS: In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure <140 mm Hg and 90 mm Hg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1-14.0; P<0.001). Remission of hypertension was present in 25 of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass, considering office and 24-hour ambulatory blood pressure monitoring, respectively, whereas no patient submitted to medical therapy was free of antihypertensive drugs at 12 months. A post hoc analysis for the primary end point considering the SPRINT (Systolic Blood Pressure Intervention Trial) target reached consistent results, with a rate ratio of 3.8 (95% confidence interval, 1.4-10.6; P=0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. CONCLUSIONS: Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.

Farmacoterapia antitrombótica intra-hospitalar e aos seis meses após intervenção coronária percutânea primária: Análise do Registro da Prática Clínica em Síndrome Coronária Aguda (ACCEPT) / In-hospital and 6-month antithrombotic therapy after primary percutaneous coronary intervention: Analysis of Acute Coronary Care Evaluation of Practice (ACCEPT) Registry

INTRODUÇÃO: O registro ACCEPT foi idealizado com o propósito de identificar a incorporação de evidências no tratamento da síndrome coronária aguda. O objetivo da presente análise é descrever a terapia antitrombótica adotada no tratamento de pacientes submetidos a intervenção coronária percutânea (ICP) primária em centros participantes desse projeto nacional. MÉTODOS: Avaliamos o subgrupo de pacientes submetidos a ICP primária, aferindo as variáveis relacionadas às características demográficas bem como à prescrição de intervenções baseadas em evidências, com enfoque na farmacoterapia antitrombótica hospitalar e aos 6 meses de seguimento. RESULTADOS: No período de agosto de 2010 a dezembro de 2011 foram avaliados 588 pacientes com média de idade de 61,8 ± 12,3 anos, 75,2% pertencentes ao sexo masculino e 24,1% portadores de diabetes melito. A terapia antiplaquetária dupla mais comumente administrada foi a associação ácido acetilsalicílico (AAS) e clopidogrel. Heparina não-fracionada e enoxaparina foram a terapêutica anticoagulante predominante durante e após o término do procedimento, respectivamente. Comparativamente à prescrição na fase intra-hospitalar, constatou-se, aos 6 meses de seguimento, queda significativa da taxa de pacientes em uso de AAS (98,3% vs. 93,9%; P < 0,0001) e clopidogrel (95,4% vs. 67,7%; P < 0,0001). CONCLUSÕES: No registro ACCEPT, elevado porcentual de prescrição hospitalar de terapia antiplaquetária dupla foi observado em pacientes submetidos a ICP primária, notadamente da associação AAS e clopidogrel, com redução inadvertida do último aos 6 meses de seguimento, motivando esforços para adequação das práticas fundamentadas por evidências.

BACKGROUND: The ACCEPT registry was designed with the purpose of identifying the incorporation of evidence in the treatment of acute coronary syndrome. The objective of this analysis is to describe the antithrombotic therapy adopted in the treatment of patients undergoing primary percutaneous coronary intervention (PCI) in centers participating in this national project. METHODS: We evaluated the subgroup of patients undergoing primary PCI, measuring variables related to demographic characteristics as well as the prescription of evidence-based interventions, focusing on in-hospital and 6-month antithrombotic therapy. RESULTS: From August 2010 to December 2011, 588 patients with mean age of 61.8 ± 12.3 years were studied, 75.2% were males and 24.1% had diabetes mellitus. The dual antiplatelet therapy most commonly given was the combination of acetylsalicylic acid (ASA) and clopidogrel. Unfractionated heparin and enoxaparin were the predominant anticoagulation therapy during and after the procedure, respectively. When compared to in-hospital prescription, a significant decrease in the rate of patients using ASA (98.3% vs 93.9%; P < 0.0001) and clopidogrel (95.4% vs 67.7%; P < 0.0001) was observed at the 6-month follow-up. CONCLUSIONS: In the ACCEPT registry, a high percentage of in-hospital prescription of dual antiplatelet therapy was observed in patients undergoing primary PCI, notably the combination of ASA and clopidogrel, with an inadvertent reduction of clopidogrel at the 6-month follow-up, encouraging efforts to use evidence-based practices.

Peculiaridades da pesquisa clínica em medicina de urgência e emergência: aspectos éticos e organizacionais / Peculiarities of clinical research in urgency and emergency medicine: ethical and organizational aspects

Justificativa e objetivos: Estudos clínicos em Medicina de urgência e emergência apresentam algumas peculiaridades em relação aos demais estudos, que por vezes dificultam sua condução, de acordo com princípios éticos e aspectos organizacionais. O objetivo deste estudo foi descrever as peculiaridades da pesquisa clínica em Medicina de urgência e emergência, para que o estudo clínico seja desenvolvido de acordo com as normas éticas, bem como discutir aspectos organizacionais de um centro de pesquisa nesta área. Conteúdo: Conforme as resoluções e normatizações nacionais e internacionais permitem-se a inclusão de sujeitos de pesquisa incapazes de fornecer consentimento informado prévio e sem possibilidade de contato com um representante legal e/ou familiar, somente quando esta for uma característica necessária para a população da pesquisa e após aprovação do Comitê de Ética em pesquisa, devendo a equipe e o centro de pesquisa organizado e adaptado a estas necessidades. Conclusão: A condução de estudos clínicos em medicina de urgência e emergência requer uma equipe qualificada e experiente a assuntos referentes à pesquisa clínica e uma estrutura física adequada. Apresenta peculiaridades, particularmente na abordagem do paciente e termo de consentimento livre e esclarecido, porém isto não isenta a aprovação de um Comitê de Ética em Pesquisa para os devidos procedimentos.

Background and objectives: Clinical trials in urgency and emergency medicine have some peculiarities in relation to other studies, thus hindering the conduct in accordance with ethical principles and organizational aspects. This article aims to describe the peculiarities of clinical research in urgency and emergency medicine for the clinical study is developed in accordance with ethical standards, and also discusses the aspects of a research center organization in this area. Contents: According to national and international laws It is possible the inclusion of subjects incapable of providing informed consent and without prior opportunity to contact a legal representative and/or family, only when it is a necessary feature for the population of the survey and only after the Ethical Committee approval, with the team and the research center are adapted to these needs. Conclusion: The conduct of clinical studies in urgency and emergency medicine and rescue team requires a qualified and experienced in the clinical research and an appropriate physical structure. Presents peculiarities with regard to the approach end of the patient and informed consent, but is not dispense for approval of the independent ethics committee.