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1.
J Am Coll Cardiol ; 83(6): 637-648, 2024 02 13.
Artículo en Inglés | MEDLINE | ID: mdl-38325988

RESUMEN

BACKGROUND: Obesity represents a major obstacle for controlling hypertension, the leading risk factor for cardiovascular mortality. OBJECTIVES: The purpose of this study was to determine the long-term effects of bariatric surgery on hypertension control and remission. METHODS: We conducted a randomized clinical trial with subjects with obesity grade 1 or 2 plus hypertension using at least 2 medications. We excluded subjects with previous cardiovascular events and poorly controlled type 2 diabetes. Subjects were assigned to Roux-en-Y gastric bypass (RYGB) combined with medical therapy (MT) or MT alone. We reassessed the original primary outcome (reduction of at least 30% of the total antihypertensive medications while maintaining blood pressure levels <140/90 mm Hg) at 5 years. The main analysis followed the intention-to-treat principle. RESULTS: A total of 100 subjects were included (76% women, age 43.8 ± 9.2 years, body mass index: 36.9 ± 2.7 kg/m2). At 5 years, body mass index was 36.40 kg/m2 (95% CI: 35.28-37.52 kg/m2) for MT and 28.01 kg/m2 (95% CI: 26.95-29.08 kg/m2) for RYGB (P < 0.001). Compared with MT, RYGB promoted a significantly higher rate of number of medications reduction (80.7% vs 13.7%; relative risk: 5.91; 95% CI: 2.58-13.52; P < 0.001) and the mean number of antihypertensive medications was 2.97 (95% CI: 2.33-3.60) for MT and 0.80 (95% CI: 0.51-1.09) for RYGB (P < 0.001). The rates of hypertension remission were 2.4% vs 46.9% (relative risk: 19.66; 95% CI: 2.74-141.09; P < 0.001). Sensitivity analysis considering only completed cases revealed consistent results. Interestingly, the rate of apparent resistant hypertension was lower after RYGB (0% vs 15.2%). CONCLUSIONS: Bariatric surgery represents an effective and durable strategy to control hypertension and related polypharmacy in subjects with obesity. (GAstric bypass to Treat obEse Patients With steAdy hYpertension [GATEWAY]; NCT01784848).


Asunto(s)
Cirugía Bariátrica , Diabetes Mellitus Tipo 2 , Derivación Gástrica , Hipertensión , Obesidad Mórbida , Humanos , Femenino , Adulto , Persona de Mediana Edad , Masculino , Presión Sanguínea , Antihipertensivos/uso terapéutico , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/cirugía , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Obesidad/complicaciones , Obesidad/cirugía , Derivación Gástrica/efectos adversos , Derivación Gástrica/métodos , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Factores de Riesgo , Resultado del Tratamiento , Obesidad Mórbida/cirugía
2.
Intensive Care Med ; 50(1): 79-89, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38010383

RESUMEN

PURPOSE: Fluid use could modulate the effect of balanced solutions (BS) on outcome of intensive care unit (ICU) patients. It is uncertain whether fluid use practices are driven more by patient features or local practices. It is also unclear whether a "dose-response" for the potential benefits of balanced solutions exists. METHODS: The secondary analysis of the Balanced Solution in Intensive Care Study (BaSICS) compared 0.9% saline versus Plasma-Lyte 148® (BS) for fluid therapy in the ICU. The relative contribution of patient features and enrolling site (the random effect) on the volume of fluid used up to day 3 after admission was assessed using different methods, including a Bayesian regression, a frequentist mixed model, and a random forest, all adjusted for relevant patient confounders. Subsequently, a variety of methods were used to assess whether volume of fluid used modulated the effect of BS on 90-day mortality, including a traditional subgroup analysis for patients that remained alive and in the ICU up to 3 days, a Bayesian network accounting for competing risks, and an analysis based on site practices. RESULTS: 10,505 patients were analyzed. Median fluid use in the BS arm and in the 0.9% saline arm were 2500 mL and 2488 mL, respectively. The random effect in the Bayesian regression explained 0.32 (95% credible intervals (CrI) 0.24-0.41) of all model variance (0.33, 95% credible intervals from 0.32-0.35). Frequentist and random forest models produced similar results. In the analysis including only patients alive and in the ICU at 3 days, there was a strong suggestion of interaction between fluid use and the effect of BS, driven mostly by a lower mortality with BS compared to 0.9% saline as fluid use increased for patients with sepsis. These results were consistent in the Bayesian network analysis and in an analysis based on site practices, where septic patients enrolled to BS at high fluid use sites had a lower mortality (absolute risk reduction of - 0.13 [95% credible interval - 0.27 to - 0.01]; 0.98 probability of benefit). CONCLUSION: Baseline patient characteristics collected in the BaSICS trial explain less of the variance of fluid use during the first 3 days than the enrolling site. Volume of fluid used and the effects of BS appear to interact, mostly in the sepsis subgroup where there was a strong association between fluid use after enrollment and the effect of BS on 90-day mortality.


Asunto(s)
Solución Salina , Sepsis , Humanos , Solución Salina/uso terapéutico , Enfermedad Crítica/terapia , Teorema de Bayes , Cuidados Críticos/métodos , Fluidoterapia/métodos , Sepsis/terapia , Unidades de Cuidados Intensivos
3.
Obes Surg ; 33(8): 2485-2492, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37392354

RESUMEN

BACKGROUND: Previous evidence explored predictors of hypertension (HTN) remission after bariatric but data are limited to observational studies and lack of ambulatory blood pressure monitoring (ABPM). This study was aimed to evaluate the rate of HTN remission after bariatric surgery using ABPM and to define predictors of mid-term HTN remission. METHODS: We included patients enrolled in the surgical arm of the GATEWAY randomized trial. HTN remission was defined as controlled blood pressure (< 130 × 80 mmHg) evaluated by 24-h ABPM while no need of anti-hypertensive medications after 36 months. A multivariable logistic regression model was used to assess the predictors of HTN remission after 36 months. RESULTS: 46 patients submitted Roux-en-Y gastric bypass (RYGB). HTN remission occurred in 39% (n = 14 out of 36 patients with complete data at 36 months). Patients with HTN remission had shorter HTN history than no remission group (5.9 ± 5.5 vs. 12.5 ± 8.1 years; p = 0.01). The baseline insulin levels were lower in patients who presented HTN remission, although not statistically significant (OR: 0.90; CI 95%: 0.80-0.99; p = 0.07). In the multivariate analysis, the HTN history (years) was the only independent predictor of HTN remission (OR: 0.85; 95% CI: 0.70-0.97; p = 0.04). Therefore, for each additional year of HTN history, the chance of HTN remission decreases by approximately 15% after RYGB. CONCLUSION: After 3 years of RYGB, HTN remission defined by ABPM was common and independently associated with a shorter HTN history. These data underscore the need of early effective approach of obesity aiming greater impact in its comorbidities.


Asunto(s)
Cirugía Bariátrica , Diabetes Mellitus Tipo 2 , Derivación Gástrica , Hipertensión , Obesidad Mórbida , Humanos , Monitoreo Ambulatorio de la Presión Arterial , Diabetes Mellitus Tipo 2/complicaciones , Hipertensión/complicaciones , Obesidad/cirugía , Obesidad Mórbida/cirugía , Estudios Retrospectivos , Resultado del Tratamiento
4.
Ann Intensive Care ; 13(1): 32, 2023 Apr 26.
Artículo en Inglés | MEDLINE | ID: mdl-37099045

RESUMEN

BACKGROUND: Nosocomial sepsis is a major healthcare issue, but there are few data on estimates of its attributable mortality. We aimed to estimate attributable mortality fraction (AF) due to nosocomial sepsis. METHODS: Matched 1:1 case-control study in 37 hospitals in Brazil. Hospitalized patients in participating hospitals were included. Cases were hospital non-survivors and controls were hospital survivors, which were matched by admission type and date of discharge. Exposure was defined as occurrence of nosocomial sepsis, defined as antibiotic prescription plus presence of organ dysfunction attributed to sepsis without an alternative reason for organ failure; alternative definitions were explored. Main outcome measurement was nosocomial sepsis-attributable fractions, estimated using inversed-weight probabilities methods using generalized mixed model considering time-dependency of sepsis occurrence. RESULTS: 3588 patients from 37 hospitals were included. Mean age was 63 years and 48.8% were female at birth. 470 sepsis episodes occurred in 388 patients (311 in cases and 77 in control group), with pneumonia being the most common source of infection (44.3%). Average AF for sepsis mortality was 0.076 (95% CI 0.068-0.084) for medical admissions; 0.043 (95% CI 0.032-0.055) for elective surgical admissions; and 0.036 (95% CI 0.017-0.055) for emergency surgeries. In a time-dependent analysis, AF for sepsis rose linearly for medical admissions, reaching close to 0.12 on day 28; AF plateaued earlier for other admission types (0.04 for elective surgery and 0.07 for urgent surgery). Alternative sepsis definitions yield different estimates. CONCLUSION: The impact of nosocomial sepsis on outcome is more pronounced in medical admissions and tends to increase over time. The results, however, are sensitive to sepsis definitions.

5.
Int J Cardiol Heart Vasc ; 36: 100853, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34345648

RESUMEN

BACKGROUND: Patients with Coronavirus Disease 2019 (COVID-19) may present high risk features during hospitalization, including cardiovascular manifestations. However, less is known about the factors that may further increase the risk of death in these patients. METHODS: We included patients with COVID-19 and high risk features according to clinical and/or laboratory criteria at 21 sites in Brazil from June 10th to October 23rd of 2020. All variables were collected until hospital discharge or in-hospital death. RESULTS: A total of 2546 participants were included (mean age 65 years; 60.3% male). Overall, 70.8% were admitted to intensive care units and 54.2% had elevated troponin levels. In-hospital mortality was 41.7%. An interaction among sex, age and mortality was found (p = 0.007). Younger women presented higher rates of death than men (30.0% vs 22.9%), while older men presented higher rates of death than women (57.6% vs 49.2%). The strongest factors associated with in-hospital mortality were need for mechanical ventilation (odds ratio [OR] 8.2, 95% confidence interval [CI] 5.4-12.7), elevated C-reactive protein (OR 2.3, 95% CI 1.7-2.9), cancer (OR 1.8, 95 %CI 1.2-2.9), and elevated troponin levels (OR 1.8, 95% CI 1.4-2.3). A risk score was developed for risk assessment of in-hospital mortality. CONCLUSIONS: This cohort showed that patients with COVID-19 and high risk features have an elevated rate of in-hospital mortality with differences according to age and sex. These results highlight unique aspects of this population and might help identifying patients who may benefit from more careful initial surveillance and potential subsequent interventional therapies.

6.
Sleep Med ; 84: 268-274, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34186452

RESUMEN

BACKGROUND: Limited evidence is available addressing the potential role of sleep disorders on renal function. Here, we aimed to explore the associations of obstructive sleep apnea (OSA) and sleep duration (SD) with renal function in subjects with high cardiovascular risk. METHODS: Consecutive subjects with coronary artery disease (CAD) underwent clinical evaluation, sleep study to define OSA and one-week wrist actigraphy to objectively measure SD. OSA was defined by an apnea-hypopnea index (AHI) of ≥15 events/hour. The estimated glomerular filtration rate (eGFR) was calculated using the CKD-EPI equation. We analyzed the associations of OSA and SD with continuous eGFR values and according to the presence of CKD (eGFR<60 mL/min/1.73 m2) after adjusting for multiple confounding factors. RESULTS: We studied 242 subjects (62.8% men). The frequency of OSA was 55.4% and the median SD was 412.8 (363.4-457.25) min. There was no difference in the eGFRs between participants with and without OSA (69.3 ± 19.1 vs. 74.6 ± 19.3 mL/min/1.73 m2, p = 0.72) and the rate of eGFR <60 mL/min/1.73 m2 (34.3% vs. 25.9%; p = 0.21). Similarly, we did not find differences in patients in eGFR for those with SD ≥ 6 h versus SD < 6 h (72.5 ± 20.3 vs. 71.4 ± 19.1 mL/min/1.73 m2, p = 0.72). In the linear regression analysis, AHI was independently associated with an eGFR<60 mL/min/1.73 m2 in the unadjusted model [-0.15 (-0.27 to -0.04)], (P = 0.01), but not in the adjusted models. Analyses of continuous SD or the stratification in SD ≥ 6 h or <6 h also revealed neutral results on eGFR. CONCLUSION: OSA severity and SD were not independently associated with CKD in subjects with CAD.


Asunto(s)
Enfermedad de la Arteria Coronaria , Insuficiencia Renal Crónica , Apnea Obstructiva del Sueño , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/epidemiología , Femenino , Humanos , Masculino , Polisomnografía , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiología , Sueño , Apnea Obstructiva del Sueño/complicaciones , Apnea Obstructiva del Sueño/epidemiología
7.
Int J Obes (Lond) ; 45(4): 914-917, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33589771

RESUMEN

BACKGROUND: Most of the evidence on bariatric surgery on obstructive sleep apnea (OSA) is based on observational studies and/or short-term follow-up in patients with obesity grade 3. SUBJECTS/METHODS: This randomized study compared the effects of roux-en-Y gastric bypass (RYGB) or usual care (UC) on OSA severity in patients with obesity grade 1-2. Mild, moderate, and severe OSA was defined by the apnea-hypopnoea index (AHI): 5-14.9; 15-29.9, and ≥30 events/h, respectively. OSA remission was defined by converting any form of OSA into normal AHI (<5 events/h). RESULTS: After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/m2, respectively. The AHI increased by 5 (-4.2; 12.7) in the UC group while reduced in the RYGB group to -13.2 (-22.7; -7) events/h. UC significantly increase the frequency of moderate OSA (from 15.4 to 46.2%). In contrast, RYGB had a huge impact on reaching no OSA status (from 4.2 to 70.8%) in parallel to a decrease of moderate (from 41.7 to 8.3%) and severe OSA (from 20.8 to 0%). CONCLUSIONS: RYGB is an attractive strategy for mid-term OSA remission or decrease moderate-to-severe forms of OSA in patients with obesity grade 1-2.


Asunto(s)
Cirugía Bariátrica , Obesidad Mórbida/cirugía , Apnea Obstructiva del Sueño/diagnóstico , Adulto , Índice de Masa Corporal , Brasil , Femenino , Derivación Gástrica , Humanos , Masculino , Persona de Mediana Edad
8.
Ann Intern Med ; 173(9): 685-693, 2020 11 03.
Artículo en Inglés | MEDLINE | ID: mdl-32805133

RESUMEN

BACKGROUND: Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain. OBJECTIVE: To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared with medical therapy (MT) alone. DESIGN: Randomized clinical trial. (ClinicalTrials.gov: NCT01784848). SETTING: Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil. PARTICIPANTS: Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m2 were randomly assigned (1:1 ratio). INTERVENTION: RYGB plus MT or MT alone. MEASUREMENTS: The primary outcome was at least a 30% reduction in total number of antihypertensive medications while maintaining BP less than 140/90 mm Hg. Key secondary outcomes were number of antihypertensive medications, hypertension remission, and BP control according to current guidelines (<130/80 mm Hg). RESULTS: Among 100 patients (76% female; mean BMI, 36.9 kg/m2 [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up. At 3 years, the primary outcome occurred in 73% of patients from the RYGB group compared with 11% of patients from the MT group (relative risk, 6.52 [95% CI, 2.50 to 17.03]; P < 0.001). Of the randomly assigned participants, 35% and 31% from the RYGB group and 2% and 0% from the MT group achieved BP less than 140/90 mm Hg and less than 130/80 mm Hg without medications, respectively. Median (interquartile range) number of medications in the RYGB and MT groups at 3 years was 1 (0 to 2) and 3 (2.8 to 4), respectively (P < 0.001). Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively. In the RYGB group, 13 patients developed hypovitaminosis B12 and 2 patients required reoperation. LIMITATION: Single-center, nonblinded trial. CONCLUSION: RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity. PRIMARY FUNDING SOURCE: Ethicon, represented in Brazil by Johnson & Johnson do Brasil.


Asunto(s)
Antihipertensivos/uso terapéutico , Cirugía Bariátrica , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Obesidad/complicaciones , Obesidad/cirugía , Adolescente , Adulto , Anciano , Anemia/etiología , Cirugía Bariátrica/efectos adversos , Presión Sanguínea , Índice de Masa Corporal , Consejo , Femenino , Derivación Gástrica , Humanos , Hiperparatiroidismo/etiología , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Obesidad/fisiopatología , Complicaciones Posoperatorias , Inducción de Remisión , Deficiencia de Vitamina B 12/etiología , Pérdida de Peso , Adulto Joven
10.
Hypertension ; 73(3): 571-577, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30661477

RESUMEN

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.


Asunto(s)
Antihipertensivos/uso terapéutico , Cirugía Bariátrica , Monitoreo Ambulatorio de la Presión Arterial/métodos , Presión Sanguínea/fisiología , Hipertensión/terapia , Obesidad/cirugía , Adulto , Índice de Masa Corporal , Brasil/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Hipertensión/epidemiología , Hipertensión/etiología , Masculino , Obesidad/complicaciones , Prevalencia , Pronóstico
11.
Neurosurgery ; 85(5): 717-728, 2019 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-30272245

RESUMEN

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.


Asunto(s)
Trastorno Depresivo Mayor/terapia , Trastorno Depresivo Resistente al Tratamiento/terapia , Terapia por Estimulación Eléctrica/métodos , Nervio Trigémino , Adulto , Enfermedad Crónica/terapia , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos de Investigación , Resultado del Tratamiento
13.
Am Heart J ; 202: 89-96, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29908420

RESUMEN

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.


Asunto(s)
Clopidogrel/uso terapéutico , Fibrinolíticos/uso terapéutico , Hemorragia/inducido químicamente , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Ticagrelor/uso terapéutico , Adulto , Anciano , Anticoagulantes/uso terapéutico , Clopidogrel/efectos adversos , Quimioterapia Combinada , Femenino , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Proyectos de Investigación , Infarto del Miocardio con Elevación del ST , Método Simple Ciego , Ticagrelor/efectos adversos
14.
Trials ; 18(1): 601, 2017 Dec 19.
Artículo en Inglés | MEDLINE | ID: mdl-29258572

RESUMEN

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.


Asunto(s)
Antiinflamatorios/administración & dosificación , Linfocitos B/efectos de los fármacos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Mediadores de Inflamación/sangre , Inhibidores de Agregación Plaquetaria/administración & dosificación , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Linfocitos T/efectos de los fármacos , Terapia Trombolítica , Adenosina/administración & dosificación , Adenosina/análogos & derivados , Antiinflamatorios/efectos adversos , Linfocitos B/inmunología , Linfocitos B/metabolismo , Biomarcadores/sangre , Brasil , Protocolos Clínicos , Clopidogrel , Angiografía Coronaria , Quimioterapia Combinada , Ensayo de Immunospot Ligado a Enzimas , Ezetimiba/administración & dosificación , Femenino , Citometría de Flujo , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Imagen por Resonancia Magnética , Masculino , Metabolómica , Inhibidores de Agregación Plaquetaria/efectos adversos , Proteómica , Proyectos de Investigación , Rosuvastatina Cálcica/administración & dosificación , Infarto del Miocardio con Elevación del ST/sangre , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/inmunología , Simvastatina/administración & dosificación , Volumen Sistólico/efectos de los fármacos , Linfocitos T/inmunología , Linfocitos T/metabolismo , Terapia Trombolítica/efectos adversos , Ticagrelor , Ticlopidina/administración & dosificación , Ticlopidina/análogos & derivados , Factores de Tiempo , Resultado del Tratamiento , Función Ventricular Izquierda/efectos de los fármacos , Remodelación Ventricular/efectos de los fármacos
15.
Rev. bras. cardiol. invasiva ; 23(1): 17-21, abr.-jun.2015. tab, graf
Artículo en Portugués | LILACS, Sec. Est. Saúde SP | ID: lil-782170

RESUMEN

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)...


Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/terapia , Sirolimus/administración & dosificación , Stents Liberadores de Fármacos , Trombosis Coronaria/fisiopatología , Estudios Prospectivos , Factores de Riesgo , Fibrinolíticos/administración & dosificación , Prótesis e Implantes/métodos , Intervención Coronaria Percutánea/métodos , Resultado del Tratamiento
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