Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial.

BACKGROUND: There is limited information about the use of antithrombotic therapies and outcomes of Latin American (LatAm) subjects with atrial fibrillation. The global ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial compared the efficacy and safety of edoxaban versus warfarin over a median follow-up of 2.8 years. OBJECTIVES: The authors aimed to compare adjusted outcomes in Latin America versus outside Latin America and to compare outcomes stratified by anticoagulant treatment and region. METHODS: The authors analyzed clinical characteristics and outcomes, adjusted for baseline characteristics, the Human Development Index, and randomized treatment of 2,661 LatAm versus 18,444 non-Latin American subjects (nLAS). RESULTS: When compared with nLAS, LatAm subjects had a similar overall risk for stroke. After multivariate adjustment, the risks of stroke/systemic embolism (hazard ratio [HR]: 1.19; 95% confidence interval (CI): 0.96 to 1.47; p = 0.11) and major bleeding (HR: 1.10; 95% CI: 0.89 to 1.36; p = 0.39) were similar in LatAm and nLAS. LatAm subjects were at higher adjusted risk of death (HR: 1.48; 95% CI: 1.30 to 1.69; p < 0.001) and intracranial hemorrhage (ICH) (HR: 1.55; 95% CI: 1.00 to 2.41; p = 0.049). In both regions, when compared with warfarin, edoxaban reduced stroke/systemic embolism (HR: 0.64 and 0.91 in LatAm and nLAS, respectively), major bleeding (HR: 0.71 and 0.82), and cardiovascular death (HR: 0.78 and 0.88), without evidence of regional heterogeneity (pint = 0.41, 0.50, and 0.70, respectively). There was a greater reduction in hemorrhagic stroke with edoxaban in LatAm (HR: 0.16) than in nLAS (HR: 0.64; pint = 0.037). CONCLUSIONS: After multivariable adjustment, LatAm subjects with atrial fibrillation had higher rates of intracranial hemorrhage and death than nLAS. Outcomes with higher-dose edoxaban versus warfarin were at least as favorable in LatAm subjects as in nLAS, with an even greater reduction in hemorrhagic stroke seen in LatAm.

Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.

BACKGROUND: Lorcaserin, a selective serotonin 2C receptor agonist that modulates appetite, has proven efficacy for weight management in overweight or obese patients. The cardiovascular safety and efficacy of lorcaserin are undefined. METHODS: We randomly assigned 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to receive either lorcaserin (10 mg twice daily) or placebo. The primary safety outcome of major cardiovascular events (a composite of cardiovascular death, myocardial infarction, or stroke) was assessed at an interim analysis to exclude a noninferiority boundary of 1.4. If noninferiority was met, the primary cardiovascular efficacy outcome (a composite of major cardiovascular events, heart failure, hospitalization for unstable angina, or coronary revascularization [extended major cardiovascular events]) was assessed for superiority at the end of the trial. RESULTS: At 1 year, weight loss of at least 5% had occurred in 1986 of 5135 patients (38.7%) in the lorcaserin group and in 883 of 5083 (17.4%) in the placebo group (odds ratio, 3.01; 95% confidence interval [CI], 2.74 to 3.30; P<0.001). Patients in the lorcaserin group had slightly better values with respect to cardiac risk factors (including blood pressure, heart rate, glycemic control, and lipids) than those in the placebo group. During a median follow-up of 3.3 years, the rate of the primary safety outcome was 2.0% per year in the lorcaserin group and 2.1% per year in the placebo group (hazard ratio, 0.99; 95% CI, 0.85 to 1.14; P<0.001 for noninferiority); the rate of extended major cardiovascular events was 4.1% per year and 4.2% per year, respectively (hazard ratio, 0.97; 95% CI, 0.87 to 1.07; P=0.55). Adverse events of special interest were uncommon, and the rates were generally similar in the two groups, except for a higher number of patients with serious hypoglycemia in the lorcaserin group (13 vs. 4, P=0.04). CONCLUSIONS: In a high-risk population of overweight or obese patients, lorcaserin facilitated sustained weight loss without a higher rate of major cardiovascular events than that with placebo. (Funded by Eisai; CAMELLIA-TIMI 61 ClinicalTrials.gov number, NCT02019264 .).

Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension / Seguridad y eficacia de fimasartán en pacientes mexicanos con hipertensión esencial de grados 1-2

Abstract: Objective: To evaluate efficacy and safety of 60 mg and 120 mg Fimasartan (FMS) alone or combined with 12.5 mg hydrochlorothiazide (HCTZ) in a Mexican population. Methods: A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60 mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90 mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90 mmHg were randomised to either 120 mg FMS or 60 mg FMS + 12.5 mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90 mmHg received 120 mg FMS + 12.5 mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study. Results: FMS 60 mg (n = 272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3 ± 8.9 (p<.0001) and 16.0 ± 14.1 (p<.0001) mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120 mg, FMS 60 mg + HCTZ 12.5 mg, or FMS 120 mg + HCTZ 12.5 mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP < 90 mmHg and an SBP<140 mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%). Conclusion: Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.

Resumen: Objetivo: Evaluar la eficacia y la seguridad de 60 y 120 mg de fimasartán (FMS) solo o combinado con 12.5 mg de hidroclorotiazida (HCTZ) en población mexicana. Métodos: Estudio abierto, de 24 semanas, con tratamiento escalado hasta el objetivo terapéutico en sujetos hipertensos grados 1-2. Tratamiento inicial: FMS 60 mg una vez al día; en la semana 8, los sujetos con presión arterial diastólica (PAD) <90 mmHg mantuvieron su tratamiento inicial durante el estudio, mientras que los sujetos con PAD ≥90 mmHg fueron aleatorizados a 120 mg de FMS o a 60 mg de FMS + 12.5 mg de HCTZ. En la semana 12, los sujetos aleatorizados con PAD ≥90 mmHg recibieron 120 mg de FMS + 12.5 mg de HCTZ; quienes alcanzaron el objetivo terapéutico mantuvieron su tratamiento asignado hasta finalizar el estudio. Resultados: FMS 60 mg (n = 272) disminuyó la PAD y la presión arterial sistólica (PAS) en 11.3 ± 8.9 (p < 0.0001) y 16.0 ± 14.1 (p < 0.0001) mmHg, respectivamente, con logro del objetivo de tratamiento en el 75.4% de los sujetos. Los sujetos asignados a 120 mg de FMS, a 60 mg de FMS + 12.5 mg de HCTZ 12.5 y a 120 mg de FMS + 12.5 mg de HCTZ mostraron reducciones significativas de PAD y PAS; al final del estudio, 237/272 sujetos (87.1%) lograron PAD <90 y PAS <140 mmHg. Las reacciones adversas más frecuentemente reportadas fueron: cefalea (3.7%), boca seca (1.1%), incremento de enzimas hepáticas (1.1%) y mareo (0.7%). Conclusión: FMS es seguro y eficaz en sujetos mexicanos con hipertensión esencial de grados 1-2.

Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension.

OBJECTIVE: To evaluate efficacy and safety of 60mg and 120mg Fimasartan (FMS) alone or combined with 12.5mg hydrochlorothiazide (HCTZ) in a Mexican population. METHODS: A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90mmHg were randomised to either 120mg FMS or 60mg FMS + 12.5mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90mmHg received 120mg FMS+12.5mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study. RESULTS: FMS 60mg (n=272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3±8.9 (p<.0001) and 16.0±14.1 (p<.0001)mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120mg, FMS 60mg+HCTZ 12.5mg, or FMS 120mg+HCTZ 12.5mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP<90mmHg and an SBP<140mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%). CONCLUSION: Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.

Global outcomes of ST-elevation myocardial infarction: comparisons of the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 (ExTRACT-TIMI 25) registry and trial.

BACKGROUND: Outcomes in patients with ST-elevation myocardial infarction (STEMI) differ between those in clinical trials and those in routine practice, as well as across different regions. We hypothesized that adjustment for baseline risk would minimize such variations. METHODS: The Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction (ExTRACT-TIMI) 25 registry was an observational study of patients with STEMI presenting to hospitals participating in the ExTRACT-TIMI 25 randomized clinical trial. Consecutive patients with STEMI who were not enrolled in the trial were entered into the registry. Demographics, in-hospital therapies, and in-hospital events were collected. Baseline risk was assessed using the TIMI Risk Index for STEMI. To adjust for differences among the countries from which the patients presented, the gross national income per annum per capita (GNI) was used. RESULTS: A total of 3726 patients were registered from 109 sites in 25 countries. Patients in the registry had a higher baseline risk than those in the trial; they had more extensive prior cardiac histories and more comorbidities. Unadjusted in-hospital mortality was higher in the registry (8.3%) than in the trial (6.6%) (hazard ratio, 1.30; P < .001); however, after adjusting for TIMI Risk Index, mortality was similar (hazard ratio(adj), 1.00; P = .97). The GNI was not significantly predictive of in-hospital mortality in the multivariable model of the registry. CONCLUSION: Patients in the registry had higher mortality than those in the trial. This difference could be explained by the higher baseline risk of patients in the registry. After adjusting for baseline risk, the GNI of the country in which the patient presented did not contribute to predicting in-hospital mortality.

[Heart transplant in "Nuevo Leon": the first 33 cases]. / Estado actual del trasplante cardíaco en Nuevo León: primeros 33 casos.

Heart failure is one of the most important causes of death worldwide. Heart transplant is the last effective alternative when the medical and surgical treatments have failed in patients with end stage heart failure, giving them an 80% one year survival rate. Unfortunately, during the outcome, the heart transplant patients can develop complications such as graft rejection and opportunistic infections because of the use of immunosuppressive therapy. In the present article we report the experience with 33 heart transplant patients. Our program not only has successfully transplanted patients with advanced age but, for the first time in Latin America we have transplanted patients assisted with the ambulatory Thoratec TLC II system. Even with limited resources, we have managed the same complications than other heart transplant programs, our 82% one year survival rate is similar than reports in medical literature.

Estado actual del trasplante cardíaco en Nuevo León: primeros 33 casos / Heart transplant in Nuevo Leon: the first 33 cases

Heart failure is one of the most important causes of death worldwide. Heart transplant is the last effective alternative when the medical and surgical treatments have failed in patients with end stage heart failure, giving them an 80% one year survival rate. Unfortunately, during the outcome, the heart transplant patients can develop complications such as graft rejection and opportunistic infections because of the use of immunosuppressive therapy. In the present article we report the experience with 33 heart transplant patients. Our program not only has successfully transplanted patients with advanced age but, for the first time in Latin America we have transplanted patients assisted with the ambulatory Thoratec TLC II system. Even with limited resources, we have managed the same complications than other heart transplant programs, our 82% one year survival rate is similar than reports in medical literature.

Mexican Registry of Acute Coronary Syndromes.

OBJECTIVE: The registry intends to establish the clinical characteristics, identify therapeutic approaches and describe in-hospital outcome of patients with acute coronary syndromes in Mexico. METHODS AND RESULTS: RENASICA II is a prospective registry that included 8,098 patients with final diagnosis of acute coronary syndromes. Three thousand five hundred and forty three patients had unstable angina or non-ST elevation myocardial infarction (UA/NSTEMI) and 4,555 ST elevation myocardial infarction. (STEMI) On admission typical chest pain was identified in 78% and 85% respectively. Non-ST elevation high risk group was identified in 36%. In STEMI group anterior myocardial infarction and Killip class I had a higher occurrence. The use of aspirin, unfractionated heparin, low molecular weight heparin, nitrates, beta blockers and ACE inhibitors for patients with UA/NSTEMI were 90%, 50%, 45%, 58%, 50% and 54% respectively, with corresponding rates of 88%, 54%, 44%, 66%, 51% and 64% for STEMI patients. Coronary angiography, angioplasty and coronary bypass surgery were performed in 62%, 30% and 8% in UA/NSTEMI patients respectively with corresponding rates of 44%, 27% and 4% for the STEMI group. Among patients with STEMI 37% were under fibrinolytic therapy and 15% received primary or facilitated angioplasty. Overall In-hospital mortality was 7%, 4% UA/NSTEMI and 10% STEMI 10%. CONCLUSION: The largest registry ACS in Latin-America provides important and reliable information on the complete spectrum, outcome, quality of care, and identifies areas for further improvement of the quality of our cardiovascular care. RENASICA II broadens our knowledge about how reperfusion and antithrombotic approaches modify the outcome and what needs to be improved in the real practice in Mexico.

Registro Mexicano de Síndromes Coronarios Agudos: RENASICA II Mexican Registry of Acute Coronary Syndromes

Objetivo: El registro pretende establecer en México las características clínicas, identificar abordajes terapéuticos y conocer la evolución hospitalaria en pacientes con síndromes coronarios agudos. Métodos y resultados: RENASICA II es un registro prospectivo que incluye 8,098 pacientes con diagnóstico final de síndrome coronario agudo. Tres mil quinientos cuarenta y tres tuvieron angina inestable o infarto sin elevación del ST (AI/IMNEST) y 4,555 con infarto con elevación del ST (IMEST). A su ingreso al hospital se identificó dolor torácico típico de isquemia en 78% y 85% respectivamente. Se consideró de alto riesgo al 36% de los pacientes con AI/IMNEST. En la mayoría de los pacientes con IMEST la localización fue anterior y se encontraban en clase KK I. En AI/IMNEST se utilizó aspirina en el 90%, heparina no fraccionada 50%, heparina de bajo peso molecular 45%, nitratos 58%, bloqueadores beta 50% e inhibidores de enzima convertidora en el 54%. En IMEST estos medicamentos se utilizaron en el 88%, 54%, 44%, 66%, 51% y 64% respectivamente. En pacientes con AI/IMNEST se realizó angiografía en el 62%, angioplastía coronaria 30% y cirugía de revascularización 8%. En el grupo con IMEST estos procedimientos se realizaron en el 44%, 27% y 4% respectivamente. En IMEST el 37% recibió terapia fibrinolítica y 15% fueron llevados a angioplastía primaria o facilitada. La mortalidad hospitalaria global del 7%, en AI/IMNEST fue del 4% y en IMEST del 10%. Conclusión: El más grande registro de síndromes coronarios agudos en Latinoamérica provee información importante sobre el espectro clínico, evolución hospitalaria, calidad de atención e identifica áreas de oportunidad para mejorar la atención médica. El RENASICA II extiende nuestro conocimiento sobre cómo la reperfusión y el tratamiento antitrombótico modifican la evolución y cuáles procesos necesitamos mejorar en la práctica real en México.

Objective: The registry intends to establish the clinical characteristics, identify therapeutic approaches and describe in-hospital outcome of patients with acute coronary syndromes in Mexico. Methods and results: RENASICA II is a prospective registry that included 8,098 patients with final diagnosis of acute coronary syndromes. Three thousand five hundred and forty three patients had unstable angina or non-ST elevation myocardial infarction (UA/NSTEMI) and 4,555 ST elevation myocardial infarction (STEMI). On admission typical chest pain was identified in 78% and 85% respectively. Non-ST elevation high risk group was identified in 36%. In STEMI group anterior myocardial infarction and Killip class I had higher occurrence. The use of aspirin, unfractionated heparin, low molecular weight heparin, nitrates, beta blockers and ACE inhibitors for patients with UA/NSTEMI were 90%, 50%, 45%, 58%, 50% and 54% respectively, with corresponding rates of 88%, 54%, 44%, 66%, 51% and 64% for STEM I patients. Coronary angiography, angioplasty and coronary bypass surgery were performed in 62%, 30% and 8% in UA/NSTEMI patients respectively with corresponding rates of 44%, 27% and 4% for STEMI group. Among patients with STEMI 37% were under fibrinolytic therapy and 15% received primary or facilitated angioplasty. Overall In-hospital mortality was 7%, 4% for UA/NSTEMI and 10% for STEMI. Conclusion: The largest registry on ACS in Latin-America provides important and reliable information on complete spectrum, outcome, quality of care, and identifies areas for further improvement of such quality. RENASICA II broadens our knowledge about how reperfusion and antithrombotic approaches modify the outcome and what needs to be improved in the real practice in Mexico.

Insuficiencia mitral post-valvuloplastía mitral con catéter balón: incidencia, factores predictores y pronóstico / Mitral regurgitation following ballon-catheter mitral valvuloplasty

Un total de 205 pacientes con diagnóstico de estenosis mitral reumática, fueron sometidos a VMTP de octubre de 1990 a octubre de 1993: 178 mujeres y 27 hombres, con edades de 16 a 72 años, media de 38. La incidencia global de insuficiencia mitral fue de 10 por ciento antes de VMPT y de 37 por ciento post-VMPT (p<0.05): fue considerada grado I en 45 pacientes (22 por ciento), grado II en 24 pacientes (12 por ciento), grado III en 4 pacientes (2 por ciento) y grado IV en 3 pacientes (1.5 por ciento), con p de 0.003, 0.002, N.S. y N.S. respectivamente. De los 205 pacientes, 83 (40 por ciento) permanecieron sin cambios en la aparición y/o progresión de la I.M., en 55 pacientes (26.8 por ciento) apareció I.M. de novo (p0.004), en 47 pacientes (23 por ciento) la I.M. aumentó un grado (p0.002) y en 20 pacientes (9.7 por ciento) la I.M. aumentó 2 o más grados (p0.007). De las 138 comisurotomías realizadas con catéter de Inoue, la incidencia de I.M. fue de 56 pacientes (40.5 por ciento), mientras que de las 67 realizadas con doble balón fue de 11 pacientes (16.4 por ciento) p0.03. En cuanto a la severidad de la I.M. con técnica de Inoue y doble balón fue: grado I en 27 por ciento vs 9 por ciento (p0.001), grado II 9.4 por ciento vs 6 por ciento (p o.05), grado III 2.1 por ciento vs 1.5 por ciento (N.S.), y grado IV 2.1 por ciento vs 0 por ciento (N.S.). Sólo la presencia de calcio en las comisuras, y una puntuación ecocardiográfica mayor de 8 puntos, fueron encontradas como variables independientes predictoras de I.M. severa. La insuficiencia mitral leve y moderada, es frecuente en los pacientes sometidos VMTP, siendo mayor cuando es realizada con catéter de Inoue con relevancia estadística. En su forma severa, la insuficiencia mitral post-VMTP es poco frecuente, y también se aprecia más comúnmente si es realizada con catéter de Inoue, aunque sin alcanzar significancia estadística

Doble ruptura miocárdica (septal y pared libre) por infarto. Reporte de un caso y revisión de la literatura / Myocardial rupture at two different sites (septum and free wall) infarction. Report one case and literature review

La ruptura miocárdica es una complicación del infarto agudo del miocardio con pronóstico fatal a corto plazo en la mayoría de las veces, especialmente cuando se trata de la pared libre. La existencias de más de un sitio de ruptura del miocardio es poco frecuente, y generalmente, estos casos han sido publicados como hallazgos de necropsia. El propósito de la presente publicación es reportar el caso de una doble ruptura del miocardio diagnosticada en vida, y considerar las implicaciones clínicas y quirúrgicas

Tromboembolia pulmonar masiva con desviación del eje eléctrico a la izquierda y bajo voltaje / Masive pulmonary embolism with left axis desviation and ion voltaje

En la Tromboembolia Pulmonar masiva o submasiva se han considerado como cambios electrocardiográficos clásicos en ausencia de cardiopatíe y/o neumopatía, la presencia de S1Q3T3 desviación del eje eléctrico a la derecha, P pulmonar, desnivel positivo o negativo del segmento ST, isquemia subepicárdica y bloqueo intermitente de la rama derecha del haz de His de grado intemedio o avanzado. Con que la desviación del eje eléctrico a la izquierda secundario a tromboembolia pulmonar se describió en 1949, éste hallazgo, así como la presencia de bajo voltaje en el plano frontal, se ha informado aisladamente en las últimas décadas, y su conocimiento ha tenido poca difusión. El objetivo del presente trabajo es comunicar el caso de una paciente con sistema cardiopulmonar previamente sano, con tromboembolia pulmonar masiva, que electrocardiográficamente presentó desviación del eje eléctro a la izquierda y bajo voltaje en el plano horizontal, atribuidos a éste padecimiento. Los mecanismos que dan lugar a éstos cambios electrocardiográficos en la tromboembolia pulmonar se desconocen. Dado que el electrocardiograma es un método inespecífico en el diagnóstico de éste padecimiento, la presencia de éstos cambios dan lugar a un mayor grado de dificultad en el diagnóstico, por lo que consideramos importante su comunicación