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Cardiogenic Shock is one of the main causes of death in ST segment Elevation Myocardial Infarction. To know the clinical characteristics, in-hospital evolution and mortality of patients with Cardiogenic Shock. Patients enrolled in the ARGEN-IAM-ST Registry were analyzed. Predictors of Cardiogenic Shock and death during hospital stay were established. A total of 6122 patients were admitted between 2015 and 2022. Cardiogenic Shock was present in 10.75% of cases. Patients with CS were older (64.5 vs 60 years), more females (41% vs 36%), with more antecedents of infarction and a higher prevalence of anterior location of infarction and multivessel disease. They were also less revascularized (88.5% vs 91.5%) and had a higher incidence of failed angioplasty (15.7% vs 2.7%). They also evidenced a higher occurrence of mechanical complications (6.8% vs 0.4%), ischemic recurrence (7.4% vs 3.4%) and cardiac arrest on admission (44.8% vs 2.6%). All the differences described showed statistical significance with P < 0.05. Overall mortality was 58% in contrast to 2.77% in patients without Cardiogenic Shock (P < 0.001). Only age, DBT, and early cardiac arrest were independent predictors of shock on admission whereas age, female gender, cardiac arrest on admission and failed angioplasty were independent predictors of death. One out of 10 patients with ST Elevation Myocardial Infarction presented cardiogenic shock. Its clinical characteristics were similar to those described more than 20 years ago. Despite a high use of reperfusion strategy cardiogenic shock continues to have a very high mortality Argentina.

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RESUMEN Introducción: El índice de masa corporal (IMC) en rangos de sobrepeso y obesidad es un factor de riesgo cardiovascular cada vez más frecuente. Su valor pronóstico es discutido en el contexto del infarto agudo de miocardio (IAM). Objetivos: Conocer características basales, estrategias de reperfusión y evolución de los casos incluidos del registro ARGENIAM ST según el IMC. Material y Métodos: Estudio prospectivo de los casos incluidos en el registro. Se excluyeron los que no presentaban datos antropométricos completos. Se definieron 3 grupos; IMC saludable: < 25 kg/m2 (G1), sobrepeso: IMC entre 25 y 29,9 kg/m2 (G2) y obesidad: IMC mayor o igual a 30 kg/m2 (G3). Resultados: Se incluyeron 2925 casos. Los pacientes del G3 tenían menor edad (G1: 63 ± 12, G2: 61 ± 11, G3: 60 ± 11 años, p = 0,0001), más frecuentemente diabetes (G1: 11%, G2: 22%, G3: 28%; p = 0,0001) y dislipidemia (G1: 35%, G2: 40%, G3: 43%; p = 0,01). No encontramos diferencias en el tiempo puerta balón, (medianas de 104 minutos en G1, 110 en G2 y 110 en G3, p = 0,27), la enfermedad de dos o más vasos (G1 38%, G2 34,5% y G3 37%; p = 0,26) y la mortalidad intrahospitalaria (G1 9,7%, G2 7,5% y G3 8,4%; p = 0,22). En el análisis multivariado el Killip y Kimball no A (OR: 20,1; IC95% 13,1-30,8; p < 0,0001), la edad (OR: 1,7; IC95 1,2-2,5; p <0,0001) y la enfermedad de dos o más vasos (OR: 1.5; IC95% 1,03-2,1; p < 0,0001) fueron predictores independientes de mortalidad en la internación. Conclusiones: Los pacientes con sobrepeso y obesidad eran más jóvenes, con más antecedentes de diabetes y dislipidemia. No hubo diferencias significativas en la forma de presentación, tratamiento y complicaciones. En el análisis multivariado el sobrepeso y la obesidad no fueron predictores de mortalidad.

ABSTRACT Background: Body mass index (BMI) in overweight and obesity ranges is an increasingly frequent cardiovascular risk factor. Its prognostic value is debatable in the setting of acute myocardial infarction (AMI). Objectives: The aim of this study is to acknowledge the clinical characteristics, reperfusion strategies outcome of the cases included in the ARGEN-IAM ST according to BMI. Methods: We conducted a prospective study of the cases included in the registry. Patients with incomplete anthropometric data were excluded. Three groups were defined: healthy BMI < 25 kg/m2 (G1), overweight: BMI between 25 and 29.9 kg/m2 (G2) and obesity: BMI ≥30 kg/m2 (G3). Results: 2925 cases were included. Patients in G3 were younger (G1: 63±12, G2: 61±11, G3: 60±11 years, p=0.0001), and had higher incidence of diabetes (G1: 11%, G2: 22%, G3: 28%; p=0.0001) and dyslipidemia (G1: 35%, G2: 40%, G3: 43%; p=0.01). There were no differences in door-to-balloon time (median 104 minutes in G1, 110 in G2 and 110 in G3, p=0.27), two-vessel disease or greater (G1 38%, G2 34.5% and G3 37%; p=0.26) and in-hospital mortality (G1 9.7%, G2 7.5% and G3 8.4%; p=0.22). In multivariate analysis Killip class other than A (OR: 20.1; 95% CI 13.1-30.8; p<0.0001), age (OR: 1.7; 95% CI 1.2-2.5; p<0.0001) and two-vessel disease or greater (OR: 1.5; 95% CI 1.03-2.1; p<0.0001) were independent predictors of in-hospital mortality. Conclusions: Overweight and obese patients were younger, with higher incidence of diabetes and dyslipidemia. There were no significant differences in the type of presentation, treatment and complications. In multivariate analysis, overweight and obesity were not predictors of mortality.

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RESUMEN Introducción: El tratamiento de reperfusión es la terapéutica de mayor eficacia para reducir la mortalidad del infarto agudo de miocardio con elevación del segmento ST (IAMCEST) , y su efectividad es inversamente proporcional al tiempo total de isquemia. El mayor desafío es instrumentar su aplicación en la vida real y corregir en forma continua los desvíos o las barreras que se presentan en la práctica cotidiana. Objetivos: Evaluar la mortalidad con las diferentes modalidades de reperfusión, su relación con el tiempo de tratamiento y su efectividad en un registro prospectivo multicéntrico del mundo real de Argentina. Material y Métodos: estudio prospectivo, multicéntrico de carácter nacional, incluidos los pacientes con IAMCEST hasta las 36 h del comienzo de los síntomas (ARGEN-IAM-ST registro continuo). Resultados: participaron 2464 pacientes de 78 centros entre 2015 y 2019. El 88,5% recibió tratamiento de reperfusión. La mortalidad fue de 8,68%. Los pacientes tratados con reperfusión tuvieron una mortalidad de 7,81% versus 15,38% sin tratamiento (p <0,001). La mortalidad con angioplastia primaria fue 7,51%, con trombolíticos 9,03%, con estrategia farmacoinvasiva 2,99% y con angioplastia de rescate 9,40%, sin diferencia estadísticamente significativa entre angioplastia primaria y trombolíticos (OR 0,81 IC 95% 0,56-1,18, p = ns). Los pacientes fallecidos fueron de mayor edad, con mayor proporción de mujeres e insuficiencia cardíaca. El tratamiento de reperfusión e ingreso a la institución dentro de 3 horas del comienzo de los síntomas se asoció a menor mortalidad. Los pacientes fallecidos con angioplastia primaria tuvieron mayor tiempo total de isquemia (378 minutos versus 285 minutos, p < 0,001). Conclusiones: La mortalidad por IAMCEST se relacionó con el acceso a la reperfusión y su precocidad. Fue mucho mayor en los pacientes no reperfundidos, y menor cuando la reperfusión se efectuó en forma precoz dentro de las primeras tres horas del comienzo de los síntomas. En los pacientes tratados con angioplastia primaria la mortalidad se incrementó con mayor tiempo total de isquemia. Este registro de la práctica real del tratamiento del IAMCEST refuerza la necesidad de una mejor articulación del sistema de atención para bajar los tiempos y utilizar la estrategia mejor y más oportuna.

ABSTRACT Background: reperfusion treatment is the most effective therapy in reducing mortality from acute ST elevation myocardial infarction and its effectiveness is inversely proportional to the total time of ischemia. The greatest challenge is to implement its application in real life and continuously correct the deviations or barriers that arise in daily practice. Objectives: to evaluate mortality with the different reperfusion modalities, its relationship with treatment time and to evaluate its effectiveness. Methods: a prospective, multicenter national study, including patients with STEMI up to 36 h after symptoms began (ARGENAMI-ST continuous registry). Results: 2464 patients were included from 2015 to 2019 in 78 centers. 88.5% received reperfusion treatment. Mortality was 8.68%. The patients treated with reperfusion had a mortality of 7.81% versus 15.38% without treatment (p <0.001). Mortality with primary angioplasty was 7.51%, thrombolytics 9.03%, pharmacoinvasive strategy 2.99%, and rescue angioplasty 9.40%, with no statistically significant difference between primary angioplasty and thrombolytics (OR 0.81; 95% CI 0.56-1.18, p = ns). The deceased patients were older, a higher proportion of women, and heart failure. Reperfusion treatment and admission to the institution within 3 hours of starting symptoms were associated with lower mortality. Patients who died with primary angioplasty had a longer total ischemia time (378 minutes versus 285 minutes, p <0.001). Conclusions: mortality from STEMI was related to access to reperfusion and its earliness. It was much higher in non-reperfused patients, and lower when reperfusion was carried out early within the first three hours of the onset of symptoms. In patients treated with primary angioplasty, mortality increased with a longer total ischemia time. This record of the actual practice of the treatment of infarction reinforces the need for a better articulation of the care system to reduce times and use the best timely strategy.

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BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients. OBJECTIVE: To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19. DESIGN, SETTING AND PARTICIPANTS: A randomized, double-blind, placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021. INTERVENTION: Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days. MAIN OUTCOMES AND MEASURES: The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points. RESULTS: The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3-6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32-1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes. LIMITATIONS: Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population. CONCLUSION: Ivermectin had no significant effect on preventing hospitalization of patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in their treatment. No significant differences were observed in any of the other secondary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04529525 .

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OBJECTIVES: To assess the efficacy of ivermectin in addition to standard treatment compared to standard treatment alone in reducing hospitalizations in the COVID-19 patient population. TRIAL DESIGN: IVERCOR-COVID19 will be a single-center, prospective, randomized, double-blind, parallel group (1:1 ratio), placebo-controlled study. PARTICIPANTS: Patients who meet the following criteria will be invited to participate: Inclusion criteria: (1) Over 18 years of age who reside in the province of Corrientes at the time of diagnosis. (2) Confirmed diagnosis of COVID-19 by polymerase chain reaction (PCR) test for detection of SARS-CoV2 in the last 48 h. (3) In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal, or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least 1 month before the time of inviting her to participate in this study). (4) Weight at the time of inclusion greater than 48 kg. (5) That they sign the informed consent for participation in the study. EXCLUSION CRITERIA: (1) pregnant or breastfeeding women; (2) known allergy to ivermectin or some of the components of ivermectin tablets or placebo; (3) current use of home oxygen; (4) require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19; (5) presence of mal-absorptive syndrome; (6) presence of any other concomitant acute infectious disease; (7) known history of severe liver disease, for example liver cirrhosis; (8) need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19; (9) need or use of hydroxychloroquine or chloroquine; (10) use of ivermectin up to 7 days prior to randomization; (11) patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months; and (12) current participation or in the last 30 days in a research study that has included the administration of a drug (Table 1). Table 1 Ivermectin/placebo dose according to patient weight Patient weight Ivermectin/placebo dose Total dose (mg) Equal to or greater than 48 kg and less than 80 kg 2 tablets of 6 mg each at the time of inclusion and 2 tablets 24 h after the first intake 24 Equal or greater than 80 kg and less than 110 kg 3 tablets of 6 mg each at the time of inclusion and 3 tablets 24 h after the first intake 36 Equal or greater than 110 kg 4 tablets of 6 mg each at the time of inclusion and 4 tablets 24 h after the first intake 48 The study will be carried out by the Ministry of Public Health of the Province of Corrientes (Argentina) in coordination with the Institute of Cardiology of Corrientes in the Province of Corrientes, Argentina. INTERVENTION AND COMPARATOR: Intervention group: patients who are randomized to ivermectin will receive the dose according to their weight (patients up to 80 kg will receive 2 tablets of 6 mg ivermectin; patients with more than 80 kg and up to 110 kg will receive 3 tablets of 6 mg of ivermectin; patients weighing more than 110 kg will receive 4 tablets of 6 mg ivermectin) the day they enter the study and the same dose 24 h after the first dose. CONTROL GROUP: patients who are randomized to placebo will receive the dose according to their weight (patients up to 80 kg will receive 2 tablets of 6 mg placebo; patients with more than 80 kg and up to 110 kg will receive 3 tablets of 6 mg of placebo; patients weighing more than 110 kg will receive 4 tablets of 6 mg placebo) on the day they enter the study and the same dose 24 h after the first dose (Table 2). Table 2 Inclusion and exclusion criteria Inclusion criteria Exclusion criteria 1. Over 18 years of age who reside in the province of Corrientes at the time of diagnosis 1. Pregnant or breastfeeding women 2.Confirmed diagnosis of COVID-19 by polymerase chain reaction test for detection of SARS-CoV2 in the last 48 h 2. Known allergy to ivermectin or some of the components of ivermectin tablets or placebo 3. In case of being women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal, or permanent contraceptives) for at least 3 months prior to inclusion in the present study, during the entire period of time for the duration of the study, and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least 1 month before the time of inviting her to participate in this study) 3. Current use of home oxygen 4. Weight at the time of inclusion equal to or greater than 48 kg 4. That require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19 5. That they sign the informed consent for participation in the study 5. Presence of mal-absorptive syndrome 6. Presence of any other concomitant acute infectious disease 7. Known history of severe liver disease, for example liver cirrhosis 8. Need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19 9. Need or use of hydroxychloroquine or chloroquine 10. Use of ivermectin up to 7 days prior to randomization 11. Patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months 12. Current participation or in the last 30 days in a research study that has included the administration of a drug MAIN OUTCOMES: Primary outcome will be the percentage of hospitalizations in patients with COVID-19 in the intervention and control groups. SECONDARY OUTCOMES: time to hospitalization in each of the arms of the study: number of days elapsed from the inclusion in the study until the hospitalization of the patient; percentage of use of invasive mechanical ventilation in each of the study arms: every patient who is connected to invasive mechanical ventilation after signing the informed consent and before the final study visit; time to invasive mechanical ventilation in each of the arms of the study: number of days elapsed from inclusion in the study to connection to invasive mechanical ventilation of the patient; percentage of patients requiring dialysis in each of the study arms: all patients who require renal replacement therapy of any kind, temporary or permanent, and which begins after signing the informed consent and before the final visit; mortality from all causes in each of the two trial groups: death of the patient, from any cause. Negative PCR swab at 3 ± 1 and 12 ± 2 days after entering the study. Ivermectin safety: it will be analyzed according to the incidence of adverse events that patients present in the intervention and control groups. The end of study (EOS) is recorded as the day the patient is discharged or death. Discharge will be granted according to the current recommendations of the Ministry of Public Health of the Province of Corrientes. A follow-up visit (EOF) will be made by phone 30 days after the EOS when vital status will be verified. RANDOMIZATION: Randomization will be done through a web system with randomly permuted blocks. Randomization will be carried out by one of the investigators who will not participate in the inclusion of patients or in the delivery of medication (Table 3). Table 3 EOS end of study, EOF end of follow-up Visit Basal and randomization, day 0 Day 3 ± 1 Day 12 ± 2 V#1 V#2 V#3 EOS EOF Informed consent X - - - - Inclusion/exclusion criteria X - - - - Demographic data and medical history X - - - - Concomitant medication X - - - - Vital signs* X X - - - Anthropometric data^ X - - - - Basal laboratory X - - - - PCR swab - X X - - Assessment of adverse events - X X X - Final objective evaluation - X X X X Randomization X - - - - Adherence to treatment X X - - - *Includes heart rate, temperature, and oxygen saturation by a digital saturometer ^Includes weight and height BLINDING (MASKING): The participants, investigators, care providers, and outcome assessors will be blinded. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): We will include a total of 500 patients (250 patients in each group). TRIAL STATUS: This is version 1.0, 17 August 2020. The recruitment started on 19 August 2020, and we anticipate the trial will finish recruitment on 31 December 2020. TRIAL REGISTRATION: ClinicalTrials.gov NCT04529525 . Registered on 26 August 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

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RESUMEN Introducción: A través del Registro Nacional de Infarto Agudo de Miocardio (IAM) con Elevación del ST (ARGEN IAM-ST) realizado en 2015 se conocieron datos de la realidad del IAM en Argentina; en esta ocasión, se presenta un reporte actual. Material y métodos: Estudio prospectivo multicéntrico, con alcance nacional. Luego de la primera fase de la encuesta ARGEN-IAM-ST, se invitó a los centros a continuar con el registro de IAM. Se incluyeron pacientes con IAM con elevación del segmento ST en el electrocardiograma de hasta 36 horas de evolución. Resultados: La población analizada abarcó 2464 pacientes asistidos en 78 centros. La media de edad fue 60 ± 12 años y el 80% fue de sexo masculino. Los factores de riesgo prevenibles se distribuyeron del siguiente modo: tabaquismo 45%, hipertensión arterial 58%, diabetes 24% y dislipidemia 41%. El 11% tuvo antecedente de enfermedad coronaria. El 88% recibió reperfusión; el 21% de estos pacientes recibieron trombolíticos y al 89% se le realizó angioplastia. La demora desde el inicio de los síntomas hasta la admisión fue de 130 minutos (RIC 25-75: 60-305); los médicos reportaron demoras hasta el tratamiento en el 49% de los casos, con impacto en los tiempos totales de isquemia (TTI). La mortalidad intrahospitalaria fue del 8,7%. En el análisis multivariado, ser tratado en un centro con hemodinamia no se asoció de forma independiente con la supervivencia. Conclusiones: Los datos actuales del registro continuo de IAM en la Argentina son similares a los que mostró la encuesta de 2015. Las demoras hasta el tratamiento son importantes, especialmente por el tiempo de demora en la consulta de los pacientes, lo que impacta en gran medida en los TTI.

ABSTRACT Background: The National ST-segment elevation Acute Myocardial Infarction (ARGEN-AMI-ST) registry carried out in 2015 provided data on the reality of AMI in Argentina. Objective: The aim of this study was to present an updated report of the ARGEN-AMI-ST registry. Methods: This was a national, prospective, multicenter study. After the first phase of the ARGEN-AMI-ST survey, centers were invited to continue with the AMI registry including patients with up to 36-hour electrocardiographic STEMI evolution. Results: The analyzed population comprised 2,464 patients assisted in 78 centers. Mean age was 60±12 years and 80% were men. Preventable risk factors were: 45% smoking, 58% hypertension, 24% diabetes, 41% dyslipidemia and 11% history of coronary heart disease. Eighty-eight percent of patients underwent reperfusion, and among them, 21% received thrombolytics and 89% percutaneous coronary intervention. The delay from onset of symptoms to admission was 130 minutes (IQR 25-75: 60-305); physicians reported delays to treatment in 49% of cases, with an impact on total ischemic times (TIT). In-hospital mortality was 8.7%. In the multivariate analysis, being treated in a center with hemodynamic availability was not independently associated with survival. Conclusions: Current data from the continuous AMI registry in Argentina are similar to those shown in the 2015 survey. Delays to treatment are important, especially due to the delay in patient consultation, which greatly impacts on TIT.

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RESUMEN Introducción: La pandemia declarada por la OMS por el virus SARS CoV2 llevó al sistema de salud argentino a prepararse para la atención de casos de COVID-19, pero se desconoce el impacto en este escenario sobre patologías prevalentes, como las cardiovasculares. Material y métodos: Se realizó una encuesta transversal en los centros que participan del registro ARGEN-IAM-ST, que se desarrolló para indagar sobre la organización institucional, la atención ambulatoria, la internación en cuidados críticos y el personal de la salud. Resultados: Se encuestaron 80 centros; el 55% eran de dependencias públicas y el 97% con servicio de cuidados críticos. El 91% de las instituciones formó un comité de crisis por la pandemia. El 65% de los centros tomó medidas de atención ambulatoria por el distanciamiento social. Para el 89% se redujeron los ingresos por patologías cardiovasculares, y la magnitud de la caída tuvo una media de 57% (DE ± 18). En 24% de los centros se registró personal de la salud contagiados con SARS-Cov2. Conclusión: Un elevado porcentaje de centros que participan del registro continuo ARGEN-IAM-ST crearon comités de crisis para reorganizar la atención; casi dos tercios de ellos tomaron medidas para seguimiento ambulatorio y se registró una importante caída de la ocupación de camas de pacientes cardiovasculares.

ABSTRACT Introduction: The pandemic declared by WHO for the SARS-CoV-2 virus prepared the Argentine health system for the care of COVID-19 cases, but in this scenario the impact on prevalent diseases, such as cardiovascular diseases, is unknown. Methods: A cross-sectional survey was conducted in the centers participating in the ARGEN-IAM-ST registry, to investigate the institutional organization, outpatient care, hospitalization in critical care areas and the situation of health care workers. Results: A total of 80 centers were surveyed; 55% were public institutions and 97% had critical care areas. Ninety-one percent of the institutions created a crisis committee due to the pandemic and 65% took measures for outpatient care due to social distancing. In 89% of the centers hospitalizations due to cardiovascular diseases declined by 57% (SD ± 18) and in 24% of the centers health care workers became infected with SARS-CoV-2. Conclusion: A high percentage of centers participating in the ARGEN-IAM-ST continuous registry created crisis committees to reorganize the delivery of health care services; almost two thirds of them took measures for outpatient follow-up and there was a significant decline in bed occupancy for patients with cardiovascular diseases.