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1.
Artigo em Inglês | MEDLINE | ID: mdl-31574228

RESUMO

RATIONALE: A recent randomized controlled trial showed that a peripheral perfusion-guided resuscitation strategy was associated with lower mortality and less organ dysfunction when compared to lactate-guided resuscitation strategy in patients with septic shock, but the difference in the main outcome, 28-day mortality, did not reach the proposed statistical significance threshold(p=0.06). We tested different analytic methods to aid in the interpretation of these clinically relevant results. OBJECTIVES: To reassess trial results using both Bayesian and frequentist frameworks. METHODS: All patients recruited in the ANDROMEDA-Shock trial were included. Both a post-hoc Bayesian and mixed logistic regression approaches were performed.The first included 4 different priors (optimistic, neutral, null and pessimistic) for mortality endpoints. The probability of having a SOFA in the lower quartile at 72 hours was assessed using Bayesian networks. RESULTS: Through a Bayesian approach, the posterior probability that a peripheral perfusion-targeted resuscitation strategy is superior to lactate-targeted resuscitation at 28-days was above 90% for all priors; the probability of benefit at 90-days was also above 90% for all but the pessimistic prior. Using an optimistic prior, the Bayesian intervention odds ratio was 0.63 (95% credible interval 0.41-0.90) and 0.69 (95% credible interval 0.47-1.01) for 28-and 90-days mortality, respectively. The comparable frequentist odds ratios for 28-day and 90-day mortality were 0.61 (95%CI0.38-0.92) and 0.70 (95%CI0.45-1.08), respectively. The odds that that patients in the peripheral perfusion-targeted resuscitation arm had SOFA scores in the lower quartile at72-hours was 1.55 (95%confidence interval1.02-2.37). Peripheral perfusion-targeted resuscitation may result in lower mortality and faster resolution of organ dysfunction when compared to a lactated-targeted resuscitation strategy. This reanalysis can aid clinicians interpret the results of the trial. Clinical trial registration available at www.clinicaltrials.gov, ID:NCT0307871.

2.
Intensive Care Med ; 45(11): 1599-1607, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31595349

RESUMO

PURPOSE: To study whether ICU staffing features are associated with improved hospital mortality, ICU length of stay (LOS) and duration of mechanical ventilation (MV) using cluster analysis directed by machine learning. METHODS: The following variables were included in the analysis: average bed to nurse, physiotherapist and physician ratios, presence of 24/7 board-certified intensivists and dedicated pharmacists in the ICU, and nurse and physiotherapist autonomy scores. Clusters were defined using the partition around medoids method. We assessed the association between clusters and hospital mortality using logistic regression and with ICU LOS and MV duration using competing risk regression. RESULTS: Analysis included data from 129,680 patients admitted to 93 ICUs (2014-2015). Three clusters were identified. The features distinguishing between the clusters were: the presence of board-certified intensivists in the ICU 24/7 (present in Cluster 3), dedicated pharmacists (present in Clusters 2 and 3) and the extent of nurse autonomy (which increased from Clusters 1 to 3). The patients in Cluster 3 exhibited the best outcomes, with lower adjusted hospital mortality [odds ratio 0.92 (95% confidence interval (CI), 0.87-0.98)], shorter ICU LOS [subhazard ratio (SHR) for patients surviving to ICU discharge 1.24 (95% CI 1.22-1.26)] and shorter durations of MV [SHR for undergoing extubation 1.61(95% CI 1.54-1.69)]. Cluster 1 had the worst outcomes. CONCLUSION: Patients treated in ICUs combining 24/7 expert intensivist coverage, a dedicated pharmacist and nurses with greater autonomy had the best outcomes. All of these features represent achievable targets that should be considered by policy makers with an interest in promoting equal and optimal ICU care.

3.
Rev. Soc. Cardiol. Estado de Säo Paulo ; 29(Suppl. 2b): 15-15, Jun. 2019.
Artigo em Português | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1008857

RESUMO

INTRODUÇÃO: Intervenção coronária percutânea (ICP) guiada por ultrassom intracoronário (USIC) associou-se com menor ocorrência de eventos adversos em comparação com ICP guiada por angiografia. A tomografia de coerência óptica (TCO) possui resolução 10 vezes maior que a do USIC. No entanto, seu papel como guia de ICP foi pouco estudado. Nosso objetivo primário é avaliar a não inferioridade da ICP guiada por TCO em comparação com a guia por USIC quanto ao desfecho primário de expansão dos stents ao final do procedimento de ICP. MÉTODOS: Pacientes com ≥ 1 lesão em coronárias nativas com 2,25-4,0 mm de diâmetro, foram randomizados (1:1:1), em blocos de 9, para ICP guiada por angiografia, USIC, e TCO. Com um α unicaudal de 0,05 e margem de não inferioridade de 6,85% para expansão dos stents, 150 pacientes (50 em cada grupo) fornece poder de 80% para investigar a não inferioridade da ICP guiada por TCO em comparação com guia por USIC. Caso a não inferioridade fosse alcançada para o desfecho primário, testamos, de forma hierárquica, a superioridade da ICP guiada por TCO vs. ICP guiada por USIC e angiografia, e ICP guiada por USIC vs. ICP guiada por angiografia. RESULTADOS: 151 pacientes foram randomizados para ICP guiada por TCO (n=51), USIC (n=51) e angiografia (n=49). A área mínima do stent pós-ICP foi semelhante entre os grupos (TCO: 7,18 ± 2,66 mm vs. USIC: 6,97 ± 2,09 mm vs. angiografia: 7,26 ± 2,48 mm, p=0.820). A expansão dos stents foi 98,01 ± 16,14% nas ICP guiadas por TCO, 91,69 ± 15,75% nas guiadas por USIC e 90,53 ± 14,84% nas guiadas por angiografia (p=0.035). Expansões obtidas sob guia da TCO foram não inferiores às obtidas com USIC (diferença TCO-USIC: 7,00; IC 95%: -0,39 a 14,39, p<0,001). Na análise hierárquica, expansão por TCO foi superior à angiografia (p=0,041), mas não superior ao USIC (p=0,067). ICP guiada por USIC não foi superior à guiada por angiografia (p=0.923). O porcentual de hastes dos stents mal apostas foi menor em ICP guiadas por TCO (TCO: 1.74 ± 1.49% vs. USIC: 3.35 ± 4.03% vs. angiografia: 4.20 ± 6.85%, p=0.035). Não houve diferença significativa quanto à ocorrência de dissecção de bordas (TCO: 15,7% vs. USIC: 15,7% vs. angiografia: 22,6%, p=0,610), e complicações dos procedimentos. CONCLUSÕES: ICP guiada por TCO gerou expansão dos stents não inferiores às obtidas com USIC, e superiores às obtidas por angiografia, com melhor aposição das hastes e sem aumento de complicações. Estes resultados indicam que TCO pode ser utilizada com segurança para guiar ICP. Seu impacto clínico deve ser futuramente investigado. (AU)


Assuntos
Humanos , Tomografia de Coerência Óptica , Intervenção Coronária Percutânea
4.
JAMA cardiol. (Online). ; 4(5): 408-417, Mai. 2019. grafico, tabela
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1022826

RESUMO

RESULTS Of the 1619 included patients,1029 (63.6%) weremale,1327(82.0%) had coronary artery disease (843[52.1%] with prioracutemyo cardial infarction),355(21.9%)had priorischemicstroke ortransientischemicattack,and197 (12.2%) had peripheral vascular disease,andthemean( SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary careunits,and 26 (65%) were teaching institutions.Amonge ligible patients,thosein intervention clusters were more like ly to receive aprescription of evidence-based therapies thant hose in control clusters (73.5%[515of701] vs58.7% [493of840];oddsratio,2.30;95%CI,1.14-4.65). There were no differences between the intervention and control group swithregard storisk factor control(ie,hyperlipidemia,hypertension,ordiabetes).Ratesofeducationforsmokingcessationwere higher among current smokers in the intervention group thanin the control group (51.9%[364of701] vs18.2%[153of840];oddsratio,11.24;95%CI,2.20-57.43).Therateofcardiovascularmortality,acute myocardial infarction,andstrokewas2.6%for patients from intervention cluster sand 3.4%forthose in the control group (hazardratio, 0.76;95%CI,0.43-1.34). (AU)


Assuntos
Humanos , Doenças Cardiovasculares/tratamento farmacológico , Medicina Baseada em Evidências/métodos , Prevenção de Doenças
5.
Br J Anaesth ; 123(1): 88-95, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30961913

RESUMO

BACKGROUND: Despite a robust physiological rationale, recruitment manoeuvres with PEEP titration were associated with harm in the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). We sought to investigate the potential heterogeneity in treatment effects in patients enrolled in the ART, using a machine learning approach. METHODS: The primary outcome was hospital mortality. Patients were clustered using baseline clinical and physiological data using the k-means for mixed large data method. The heterogeneity in treatment effect between clusters was investigated using Bayesian methods. We further investigated whether baseline driving pressure could modulate the association between treatment arm, cluster, and mortality. RESULTS: Data from all 1010 patients enrolled in the ART were analysed. Partitioning suggested that three clusters were present in the ART population. The largest cluster (Cluster 1) was characterised by patients with pneumonia and requiring vasopressor support. Recruitment manoeuvres with PEEP titration were associated with higher mortality in Cluster 1 (probability of harm of >98%), but this association was absent in Clusters 2 and 3 (probability of harm of 45% and 68%, respectively). Higher baseline driving pressure was associated with a progressive reduction in the association between alveolar recruitment with PEEP titration and mortality. CONCLUSIONS: Recruitment manoeuvre with PEEP titration may be harmful in acute respiratory distress syndrome (ARDS) patients with pneumonia or requiring vasopressor support. Driving pressure appears to modulate the association between the ART study intervention, aetiology of ARDS, and mortality. This machine learning approach may help tailor future RCTs. CLINICAL TRIAL REGISTRATION: NCT01374022.


Assuntos
Aprendizado de Máquina , Respiração com Pressão Positiva , Alvéolos Pulmonares/fisiopatologia , Síndrome do Desconforto Respiratório do Adulto/fisiopatologia , Síndrome do Desconforto Respiratório do Adulto/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Teorema de Bayes , Protocolos Clínicos , Análise por Conglomerados , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
6.
J Am Coll Cardiol ; 73(22): 2819-2828, 2019 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-30898608

RESUMO

BACKGROUND: The efficacy of ticagrelor in the long-term post-ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytic therapy remains uncertain. OBJECTIVES: The purpose of this study was to evaluate the efficacy of ticagrelor when compared with clopidogrel in STEMI patients treated with fibrinolytic therapy. METHODS: This international, multicenter, randomized, open-label with blinded endpoint adjudication trial enrolled 3,799 patients (age <75 years) with STEMI receiving fibrinolytic therapy. Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300- to 600-mg loading dose, 75 mg daily thereafter). The key outcomes were cardiovascular mortality, myocardial infarction, or stroke, and the same composite outcome with the addition of severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events at 12 months. RESULTS: The combined outcome of cardiovascular mortality, myocardial infarction, or stroke occurred in 129 of 1,913 patients (6.7%) receiving ticagrelor and in 137 of 1,886 patients (7.3%) receiving clopidogrel (hazard ratio: 0.93; 95% confidence interval: 0.73 to 1.18; p = 0.53). The composite of cardiovascular mortality, myocardial infarction, stroke, severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events occurred in 153 of 1,913 patients (8.0%) treated with ticagrelor and in 171 of 1,886 patients (9.1%) receiving clopidogrel (hazard ratio: 0.88; 95% confidence interval: 0.71 to 1.09; p = 0.25). The rates of major, fatal, and intracranial bleeding were similar between the ticagrelor and clopidogrel groups. CONCLUSION: Among patients age <75 years with STEMI, administration of ticagrelor after fibrinolytic therapy did not significantly reduce the frequency of cardiovascular events when compared with clopidogrel. (Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis [TREAT]; NCT02298088).

7.
Hypertension ; 73(3): 571-577, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30661477

RESUMO

Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m2). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0-1] versus 3 [2.5-4] classes; P<0.01). The average real variability of systolic nighttime BP was lower after RYGB as compared to medical therapy (between-group difference, -1.63; 95% CI, -2.91 to -0.36; P=0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P=0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P<0.001). In conclusion, RYGB significantly reduced antihypertensive medications while promoting similar 24-hour BP profile and nondipping status. Interestingly, bariatric surgery improved BP variability and may decrease the burden of resistant hypertension associated with obesity. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01784848.


Assuntos
Anti-Hipertensivos/uso terapêutico , Cirurgia Bariátrica , Monitorização Ambulatorial da Pressão Arterial/métodos , Pressão Sanguínea/fisiologia , Hipertensão/terapia , Obesidade/cirurgia , Adulto , Índice de Massa Corporal , Brasil/epidemiologia , Feminino , Seguimentos , Humanos , Hipertensão/epidemiologia , Hipertensão/etiologia , Masculino , Obesidade/complicações , Prevalência , Prognóstico
8.
Crit Care ; 23(1): 34, 2019 Jan 29.
Artigo em Inglês | MEDLINE | ID: mdl-30696474

RESUMO

BACKGROUND: Although light sedation levels are associated with several beneficial outcomes for critically ill patients on mechanical ventilation, the majority of patients are still deeply sedated. Organizational factors may play a role on adherence to light sedation levels. We aimed to identify organizational factors associated with a moderate to light sedation target on the first 48 h of mechanical ventilation, as well as the association between early achievement of within-target sedation and mortality. METHODS: This study is a secondary analysis of a multicenter two-phase study (prospective cohort followed by a cluster-randomized controlled trial) performed in 118 Brazilian ICUs. We included all critically ill patients who were on mechanical ventilation 48 h after ICU admission. A moderate to light level of sedation or being alert and calm (i.e., the Richmond Agitation-Sedation Scale of - 3 to 0) was the target for all patients on mechanical ventilation during the study period. We collected data on the type of hospital (public, private, profit and private, nonprofit), hospital teaching status, nursing and physician staffing, and presence of sedation, analgesia, and weaning protocols. We used multivariate random-effects regression with ICU and study phase as random-effects and correction for patients' Simplified Acute Physiology Score 3 and Sequential Organ Failure Assessment. We also performed a mediation analysis to explore whether sedation level was just a mediator of the association between organizational factors and mortality. RESULTS: We included 5719 patients. Only 1710 (29.9%) were on target sedation levels on day 2. Board-certified intensivists on the morning and afternoon shifts were associated with an adequate sedation level on day 2 (OR = 2.43; CI 95%, 1.09-5.38). Target sedation levels were associated with reduced hospital mortality (OR = 0.63; CI 95%, 0.55-0.72). Mediation analysis also suggested such an association, but did not suggest a relationship between the physician staffing model and hospital mortality. CONCLUSIONS: Board-certified intensivists on morning and afternoon shifts were associated with an increased number of patients achieving lighter sedation goals. These findings reinforce the importance of organizational factors, such as intensivists' presence, as a modifiable quality improvement target.


Assuntos
Lista de Checagem/normas , Sedação Profunda/métodos , Respiração Artificial/métodos , Adulto , Idoso , Brasil , Lista de Checagem/estatística & dados numéricos , Estudos de Coortes , Sedação Consciente/métodos , Feminino , Mortalidade Hospitalar , Humanos , Hipnóticos e Sedativos/efeitos adversos , Hipnóticos e Sedativos/uso terapêutico , Unidades de Terapia Intensiva/organização & administração , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Escores de Disfunção Orgânica , Estudos Prospectivos , Respiração Artificial/mortalidade , Escala Psicológica Aguda Simplificada
9.
Neurosurgery ; 2018 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-30272245

RESUMO

BACKGROUND: More than 30% of major depressive disorder patients fail to respond to adequate trials of medications and psychotherapy. While modern neuromodulation approaches (ie, vagal nerve stimulation, deep brain stimulation) are yet to prove their efficacy for such cases in large randomized controlled trials, trigeminal nerve stimulation (TNS) has emerged as an alternative with promising effects on mood disorders. OBJECTIVE: To assess efficacy, safety, tolerability, and placebo effect duration of continuous subcutaneous TNS (sTNS) in treatment-resistant depression (TRD). METHODS: The TREND study is a single-center, double-blind, randomized, controlled, phase II clinical trial. Twenty unipolar TRD patients will receive V1 sTNS as adjuvant to medical therapy and randomized to active vs sham stimulation throughout a 24-wk period. An additional 24-wk open-label phase will follow. Data concerning efficacy, placebo response, relapse, and side effects related to surgery or electrical stimulation will be recorded. We will use the HDRS-17, BDI-SR, IDS_SR30, and UKU scales. EXPECTED OUTCOMES: The main outcome measure is improvement in depression scores using HAM-17 under continuous sTNS as adjuvant to antidepressants. Active stimulation is expected to significantly impact response and remission rates. Minor side effects are expected due to the surgical procedure and electrical stimulation. The open-label phase should further confirm efficacy and tolerability. DISCUSSION: This study protocol is designed to define efficacy of a novel adjuvant therapy for TRD. We must strive to develop safe, reproducible, predictable, and well-tolerated neuromodulation approaches for TRD patients impaired to manage their lives and contribute with society.

11.
Am Heart J ; 202: 89-96, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29908420

RESUMO

BACKGROUND: The safety and efficacy of ticagrelor in patients with ST-elevation myocardial infarction (STEMI) treated with fibrinolytic therapy remain uncertain. OBJECTIVES: The primary objective of the TicagRElor in pAtients with ST elevation myocardial infarction treated with Thrombolysis (TREAT) trial is to evaluate the short-term safety of ticagrelor when compared with clopidogrel in STEMI patients treated with fibrinolytic therapy. Key secondary objectives are to assess the safety and efficacy of ticagrelor compared with clopidogrel at 12-months. DESIGN: The TREAT trial is a multicenter, randomized, phase III, Prospective randomized open blinded end-point (PROBE) study that enrolled 3,799 patients in 152 sites from 10 countries. Following administration of fibrinolytic therapy patients were randomized to a loading dose of ticagrelor 180 mg or clopidogrel 300 mg followed by a maintenance dose of ticagrelor 90 mg twice daily or clopidogrel 75 mg/day for 12-months. The primary outcome is the rate of TIMI major bleeding at 30-days and will be assessed for non-inferiority using an intention-to-treat analysis. Co-treatments include aspirin and anticoagulants. Other evidence based therapies are also recommended. Secondary efficacy outcome include a composite of death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, transient ischemic attack or other arterial thrombotic event. All-cause mortality as well as individual components of the combined efficacy endpoint will also be ascertained. SUMMARY: TREAT is an international randomized controlled trial comparing ticagrelor with clopidogrel in STEMI patients treated with fibrinolytic therapy. The results of this trial will inform clinical practice and international guidelines.

12.
Neurosurgery ; 83(4): 800-809, 2018 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-29538761

RESUMO

BACKGROUND: Human morbid obesity is increasing worldwide in an alarming way. The hypothalamus is known to mediate its mechanisms. Deep brain stimulation (DBS) of the ventromedial hypothalamus (VMH) may be an alternative to treat patients refractory to standard medical and surgical therapies. OBJECTIVE: To assess the safety, identify possible side effects, and to optimize stimulation parameters of continuous VMH-DBS. Additionally, this study aims to determine if continuous VMH-DBS will lead to weight loss by causing changes in body composition, basal metabolism, or food intake control. METHODS: The BLESS study is a feasibility study, single-center open-label trial. Six patients (body mass index > 40) will undergo low-frequency VMH-DBS. Data concerning timing, duration, frequency, severity, causal relationships, and associated electrical stimulation patterns regarding side effects or weight changes will be recorded. EXPECTED OUTCOMES: We expect to demonstrate the safety, identify possible side effects, and to optimize electrophysiological parameters related to VMH-DBS. No clinical or behavioral adverse changes are expected. Weight loss ≥ 3% of the basal weight after 3 mo of electrical stimulation will be considered adequate. Changes in body composition and increase in basal metabolism are expected. The amount of food intake is likely to remain unchanged. DISCUSSION: The design of this study protocol is to define the safety of the procedure, the surgical parameters important for target localization, and additionally the safety of long-term stimulation of the VMH in morbidly obese patients. Novel neurosurgical approaches to treat metabolic and autonomic diseases can be developed based on the data made available by this investigation.

13.
JAMA Cardiol ; 3(5): 391-399, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29525822

RESUMO

Importance: The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain. Objective: To evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy. Design, Setting and Participants: We conducted a multicenter, randomized, open-label with blinded end point adjudication trial that enrolled 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites from 10 countries from November 2015 through November 2017. The prespecified upper boundary for noninferiority for bleeding was an absolute margin of 1.0%. Interventions: Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter). Patients were randomized with a median of 11.4 hours after fibrinolysis, and 90% were pretreated with clopidogrel. Main Outcomes and Measures: The primary outcome was thrombolysis in myocardial infarction (TIMI) major bleeding through 30 days. Results: The mean (SD) age was 58.0 (9.5) years, 2928 of 3799 patients (77.1%) were men, and 2177 of 3799 patients (57.3%) were white. At 30 days, TIMI major bleeding had occurred in 14 of 1913 patients (0.73%) receiving ticagrelor and in 13 of 1886 patients (0.69%) receiving clopidogrel (absolute difference, 0.04%; 95% CI, -0.49% to 0.58%; P < .001 for noninferiority). Major bleeding defined by the Platelet Inhibition and Patient Outcomes criteria and by the Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 23 patients (1.20%) in the ticagrelor group and in 26 patients (1.38%) in the clopidogrel group (absolute difference, -0.18%; 95% CI, -0.89% to 0.54; P = .001 for noninferiority). The rates of fatal (0.16% vs 0.11%; P = .67) and intracranial bleeding (0.42% vs 0.37%; P = .82) were similar between the ticagrelor and clopidogrel groups, respectively. Minor and minimal bleeding were more common with ticagrelor than with clopidogrel. The composite of death from vascular causes, myocardial infarction, or stroke occurred in 76 patients (4.0%) treated with ticagrelor and in 82 patients (4.3%) receiving clopidogrel (hazard ratio, 0.91; 95% CI, 0.67-1.25; P = .57). Conclusions and Relevance: In patients younger than 75 years with ST-segment elevation myocardial infarction, delayed administration of ticagrelor after fibrinolytic therapy was noninferior to clopidogrel for TIMI major bleeding at 30 days. Trial Registration: clinicaltrials.gov Identifier: NCT02298088.

14.
Trials ; 18(1): 601, 2017 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-29258572

RESUMO

BACKGROUND: Early reperfusion of the occluded coronary artery during acute myocardial infarction is considered crucial for reduction of infarcted mass and recovery of ventricular function. Effective microcirculation and the balance between protective and harmful lymphocytes may have roles in reperfusion injury and may affect final ventricular remodeling. METHODS/DESIGN: BATTLE-AMI is an open-label, randomized trial comparing the effects of four therapeutic strategies (rosuvastatin/ticagrelor, rosuvastatin/clopidogrel, simvastatin plus ezetimibe/ticagrelor, or simvastatin plus ezetimibe/clopidogrel) on infarcted mass and left ventricular ejection fraction (LVEF) (blinded endpoints) in patients with ST-segment elevation myocardial infarction submitted to fibrinolytic therapy before coronary angiogram (pharmacoinvasive strategy). All patients (n = 300, 75 per arm) will be followed up for six months. The effects of treatment on subsets of B and T lymphocytes will be determined by flow-cytometry/ELISPOT and will be correlated with the infarcted mass, LVEF, and microcirculation perfusion obtained by cardiac magnetic resonance imaging. The primary hypothesis is that the combined rosuvastatin/ticagrelor therapy will be superior to other therapies (particularly for the comparison with simvastatin plus ezetimibe/clopidogrel) for the achievement of better LVEF at 30 days (primary endpoint) and smaller infarcted mass (secondary endpoint) at 30 days and six months. The trial will also evaluate the improvement in the immune/inflammatory responses mediated by B and T lymphocytes. Omics field (metabolomics and proteomics) will help to understand these responses by molecular events. DISCUSSION: BATTLE-AMI is aimed to (1) evaluate the role of subsets of lymphocytes on microcirculation improvement and (2) show how the choice of statin/antiplatelet therapy may affect cardiac remodeling after acute myocardial infarction with ST elevation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02428374 . Registered on 28 September 2014.


Assuntos
Anti-Inflamatórios/administração & dosagem , Linfócitos B/efeitos dos fármacos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Mediadores da Inflamação/sangue , Inibidores da Agregação de Plaquetas/administração & dosagem , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Linfócitos T/efeitos dos fármacos , Terapia Trombolítica , Adenosina/administração & dosagem , Adenosina/análogos & derivados , Anti-Inflamatórios/efeitos adversos , Linfócitos B/imunologia , Linfócitos B/metabolismo , Biomarcadores/sangue , Brasil , Protocolos Clínicos , Clopidogrel , Angiografia Coronária , Quimioterapia Combinada , ELISPOT , Ezetimiba/administração & dosagem , Feminino , Citometria de Fluxo , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Imagem por Ressonância Magnética , Masculino , Metabolômica , Inibidores da Agregação de Plaquetas/efeitos adversos , Proteômica , Projetos de Pesquisa , Rosuvastatina Cálcica/administração & dosagem , Infarto do Miocárdio com Supradesnível do Segmento ST/sangue , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/imunologia , Sinvastatina/administração & dosagem , Volume Sistólico/efeitos dos fármacos , Linfócitos T/imunologia , Linfócitos T/metabolismo , Terapia Trombolítica/efeitos adversos , Ticagrelor , Ticlopidina/administração & dosagem , Ticlopidina/análogos & derivados , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda/efeitos dos fármacos , Remodelação Ventricular/efeitos dos fármacos
15.
Diabetes Res Clin Pract ; 127: 275-284, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28412543

RESUMO

AIMS: The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country. METHODS: REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke). RESULTS: A total of 5006 subjects was included and analyzed in four groups: No diabetes and no previous cardiovascular event, n=430; diabetes and no previous cardiovascular event, n=1138; no diabetes and previous cardiovascular event, n=1747; and diabetes and previous cardiovascular event, n=1691. Major clinical events in one-year follow-up occurred in 332 patients. A previous cardiovascular event was associated with a higher risk of having another event in the follow-up (HR 2.31 95% CI 1.74-3.05, p<0.001), as did the presence of diabetes (HR 1.28 95% CI 1.10-1.73, p=0.005). In patients with diabetes,failure to reach HbA1c targetswas related topoorer event-free survival compared to patients with good metabolic control (HR 1.70 95% CI 1.01-2.84, p=0.044). CONCLUSIONS: In Brazil, diabetes confers high risk for major clinical events, but this condition is not equivalent to having a previous cardiovascular event. Moreover, not so strict targets for HbA1c in patients with diabetes and previous cardiovascular events might be considered.


Assuntos
Doenças Cardiovasculares/etiologia , Diabetes Mellitus Tipo 2/etiologia , Brasil , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/patologia , Diabetes Mellitus Tipo 2/mortalidade , Diabetes Mellitus Tipo 2/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Fatores de Risco , Classe Social
16.
Trials ; 18(1): 601-601, 2017.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-36830

RESUMO

BACKGROUND: Early reperfusion of the occluded coronary artery during acute myocardial infarction is considered crucial for reduction of infarcted mass and recovery of ventricular function. Effective microcirculation and the balance between protective and harmful lymphocytes may have roles in reperfusion injury and may affect final ventricular remodeling. METHODS/DESIGN: BATTLE-AMI is an open-label, randomized trial comparing the effects of four therapeutic strategies (rosuvastatin/ticagrelor, rosuvastatin/clopidogrel, simvastatin plus ezetimibe/ticagrelor, or simvastatin plus ezetimibe/clopidogrel) on infarcted mass and left ventricular ejection fraction (LVEF) (blinded endpoints) in patients with ST-segment elevation myocardial infarction submitted to fibrinolytic therapy before coronary angiogram (pharmacoinvasive strategy). All patients (n = 300, 75 per arm) will be followed up for six months. The effects of treatment on subsets of B and T lymphocytes will be determined by flow-cytometry/ELISPOT and will be correlated with the infarcted mass, LVEF, and microcirculation perfusion obtained by cardiac magnetic resonance imaging. The primary hypothesis is that the combined rosuvastatin/ticagrelor therapy will be superior to other therapies (particularly for the comparison with simvastatin plus ezetimibe/clopidogrel) for the achievement of better LVEF at 30 days (primary endpoint) and smaller infarcted mass (secondary endpoint) at 30 days and six months...(AU)


Assuntos
Infarto do Miocárdio , Linfócitos B , Espectroscopia de Ressonância Magnética , Metabolômica , Proteômica
17.
Diabetes Res Clin Pract ; 127: 275-284, 2017. tab, ilus
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-37395

RESUMO

AIMS:The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country.METHODS:REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke). (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/patologia , Diabetes Mellitus/etiologia , Diabetes Mellitus/mortalidade , Diabetes Mellitus/patologia
19.
Crit Care Resusc ; 17(2): 113-21, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26017129

RESUMO

BACKGROUND: The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (Checklist- ICU) trial is a pragmatic, two-arm, cluster-randomised trial involving 118 intensive care units in Brazil, with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist, definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality. OBJECTIVE: To describe our trial statistical analysis plan (SAP). METHODS: This is an ongoing trial conducted in two phases. In the preparatory observational phase, we collect three sets of baseline data: ICU characteristics; patient characteristics, processes of care and outcomes; and completed safety attitudes questionnaires (SAQs). In the randomised phase, ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ. RESULTS: Our SAP includes the prespecified model for the primary and secondary outcome analyses, which account for the cluster-randomised design and availability of baseline data. We also detail the multiple mediation models that we will use to assess our secondary hypothesis (that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist, but also through changes in safety culture). We describe our approach to sensitivity and subgroup analyses and missing data. CONCLUSION: We report our SAP before closing our study database and starting analysis. We anticipate that this should prevent analysis bias and enhance the utility of results.


Assuntos
Lista de Checagem , Análise por Conglomerados , Cuidados Críticos , Interpretação Estatística de Dados , Melhoria de Qualidade , Projetos de Pesquisa , Adulto , Viés , Brasil , Humanos , Avaliação de Resultados (Cuidados de Saúde)
20.
Rev. bras. cardiol. invasiva ; 23(1): 17-21, abr.-jun.2015. tab, graf
Artigo em Português | LILACS | ID: lil-782170

RESUMO

Stents farmacológicos (SF) de segunda geração demonstraram melhor desempenho clínico que os de primeira geração, sobretudo pela redução nas taxas de trombose, mas ainda não está claro se esse benefício se estende a diabéticos da prática diária. Objetivamos comparar o desempenho de pacientes diabéticos não selecionados tratados com SF eluidores de sirolimus (SES; primeira geração) vs. SF eluidoresde everolimus (SEE; segunda geração).Métodos: Entre 2007 e 2014, 798 diabéticos foram tratados com SES (n = 414) ou SEE (n = 384) e incluídosnesta análise. Seguimento clínico tardio foi obtido em 99,4% da população e os grupos foram comparados quanto à ocorrência de eventos cardíacos adversos maiores (ECAM) e trombose de stent. Resultados: A idade da população foi semelhante, com predomínio do sexo masculino. Em ambas as coortes, a apresentação clínica mais frequente foi a doença coronária estável. Número de vasos tratados (1,50 ± 0,62 vs. 1,52 ± 0,72; p = 0,88) e extensão total de stents (36,1 ± 20,4 mm vs. 37,7 ± 22,2 mm; p = 0,32) foram semelhantes. Os pacientes tratados com SEE apresentaram menores taxas de ECAM (15% vs. 6,8%; p < 0,001), sobretudo à custa de menor mortalidade cardíaca (5,3% vs. 1,3%; p < 0,001). Observou-se também menor ocorrência de trombose de stent definitiva/provável com SF de segunda geração (3,4% vs. 0,5%; p = 0,004).Conclusões: Nesta experiência unicêntrica, o uso de SEE em diabéticos mostrou-se com menor mortalidadecardíaca e trombose da endoprótese. Esse benefício se fez mais evidente no seguimento mais tardio...


Despite the better clinical performance of second-generation drug-eluting stents (DES)when compared to first-generation DES in controlled trials, mainly due to reduction in thrombosis rate, it remains unclear whether this benefit extends to diabetic patients treated in the daily practice. We sought to compare the clinical outcomes of unselected diabetic patients treated with either sirolimus eluting stents - SES (first-generation DES) or everolimus-eluting stents - EES (second-generation DES). Methods: Between January 2007 and October 2014 a total of 798 diabetic patients were treated with SES(n = 414) and EES (n = 384). Long-term clinical follow-up was achieved in 99,4% of the population andthe groups were compared regarding the occurrence of major adverse cardiac events (MACE) and stent thrombosis. Results: In both cohorts age was similar, and most patients were male. Stable coronary disease was the most frequent clinical presentation. The number of treated vessels (1.50 ± 0.62 vs. 1.52 ± 0.72; p = 0.88)and the total stent length (36.1 ± 20.4 vs. 37.7 ± 22.2 mm; p = 0.32) were similar between groups. Patients treated with EES showed lower rates of MACE (15% vs. 6.8%, p < 0.001), mainly due to a lower cardiac death(5.3% vs. 1.3%, p < 0.001). There was also less definitive/ probable thrombosis with the second generation DES (3.4% vs. 0.5%, p = 0.004)...


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Stents Farmacológicos , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/terapia , Sirolimo/administração & dosagem , Trombose Coronária/fisiopatologia , Fibrinolíticos/administração & dosagem , Próteses e Implantes/métodos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Fatores de Risco , Resultado do Tratamento
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