RESUMEN
BACKGROUND: Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome. METHODS: We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events. RESULTS: The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events. With a median follow-up of 241 days, the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 279 of the 3705 patients (7.5%) assigned to apixaban (13.2 events per 100 patient-years) and in 293 of the 3687 patients (7.9%) assigned to placebo (14.0 events per 100 patient-years) (hazard ratio with apixaban, 0.95; 95% confidence interval [CI], 0.80 to 1.11; P=0.51). The primary safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition occurred in 46 of the 3673 patients (1.3%) who received at least one dose of apixaban (2.4 events per 100 patient-years) and in 18 of the 3642 patients (0.5%) who received at least one dose of placebo (0.9 events per 100 patient-years) (hazard ratio with apixaban, 2.59; 95% CI, 1.50 to 4.46; P=0.001). A greater number of intracranial and fatal bleeding events occurred with apixaban than with placebo. CONCLUSIONS: The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events. (Funded by Bristol-Myers Squibb and Pfizer; APPRAISE-2 ClinicalTrials.gov number, NCT00831441.).
Asunto(s)
Síndrome Coronario Agudo/tratamiento farmacológico , Aspirina/uso terapéutico , Inhibidores del Factor Xa , Inhibidores de Agregación Plaquetaria/uso terapéutico , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Síndrome Coronario Agudo/mortalidad , Anciano , Angina Inestable/epidemiología , Angina Inestable/prevención & control , Aspirina/efectos adversos , Método Doble Ciego , Quimioterapia Combinada , Femenino , Hemorragia/inducido químicamente , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Infarto del Miocardio/prevención & control , Inhibidores de Agregación Plaquetaria/efectos adversos , Modelos de Riesgos Proporcionales , Pirazoles/efectos adversos , Piridonas/efectos adversos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , Resultado del TratamientoRESUMEN
Ischemic heart disease is the leading cause of death and heart failure worldwide. That is why it is important to develop new therapeutic modalities to decrease mortality and long-term complications in these patients. One of the main lines of research worldwide is myocardial regeneration, using progenitor cells in order to improve systolic and diastolic function in patients with ischemic heart disease, as well as to increase their survival. There have been carried out, with great enthusiasm worldwide, human and animal studies to define the usefulness of stem cells in the management of patients with ischemic heart disease. Today, regenerative therapy in ischemic heart disease is considered a novel therapeutic tool, with substantial theoretical benefits and few side effects. Here we present the scientific principles that support the use of this therapy, discuss the current clinical evidence available; and point out the controversial issues still not clarified on its use and usefulness in the short and long term.
Asunto(s)
Isquemia Miocárdica/cirugía , Trasplante de Células Madre , Ensayos Clínicos como Asunto , HumanosRESUMEN
Background and aims: Dyslipidaemia is a significant risk factor for cardiovascular disease in the Mexican population. This analysis aimed to describe the baseline LDL-c levels of patients presenting to cardiovascular clinics and evaluate the proportion who achieved their risk-based LDL-c goals as recommended by 2021 ESC prevention guidelines. Methods: The REMECAR registry is an observational study of patients attending a specialized cardiovascular clinic for their first visit. The cardiovascular risk was retrospectively determined using the 2021 ESC guideline stratification and the SCORE2 and SCORE-OP. Results: A total of 5443 patients were included in the analysis. Within this population, 55.96% presented as very high, 39.98% as high and 4.06% as moderate to low risk. 63% of the participants were not on any lipid-lowering treatment at entry, while 12.4% were receiving high-intensity statin therapy. Patients presenting with established atherosclerotic cardiovascular disease had a mean LDL-c of 90.9 ± 40.7 mg/dL. Of these, 14.1% were achieving LDL-c levels of 70-55 mg/dL and 19.3% were achieving LDL-c levels <55 mg/dL. In diabetic patients at very high risk, only 25.7% achieved their LDL-c goal. Finally, in patients without another risk factor and very high-risk evaluated by SCORE2 & SCORE-OP, only 14% of patients achieved their LDL-c goals. Conclusions: An important number of patients were not receiving any lipid-lowering therapy. Furthermore, in those who were, a significant portion did not achieve LDL-c recommended thresholds. Our results underline the urgent need to improve the prescription and optimization of lipid-lowering therapy as the current management appears to be insufficient for achieving optimal recommended goals. Identifying key barriers in lipid management is fundamental to establishing better strategies and health system policies to reduce cardiovascular risk.
RESUMEN
La cardiopatía isquémica es la principal causa de muerte e insuficiencia cardiaca a nivel mundial. Esto hace de vital importancia el desarrollo de nuevas modalidades terapéuticas, que disminuyan la mortalidad y complicaciones a largo plazo en estos pacientes. Una de las principales líneas de investigación a nivel mundial es la regeneración miocárdica a partir de células progenitoras, con el fin de mejorar la función sistólica y diastólica de los pacientes con cardiopatía isquémica, además de incrementar su sobrevida. Con bases teóricas y fisiológicas sobre la función de estas células, se han llevado a cabo con gran entusiasmo a nivel mundial, estudios en animales y humanos para tratar de definir la utilidad del empleo de las células madre, en el manejo de los pacientes con cardiopatía isquémica. En la actualidad, la terapia regenerativa en la cardiopatía isquémica es considerada una herramienta terapéutica novedosa, de beneficios teóricos considerables y pocos efectos adversos. En esta revisión presentamos los fundamentos científicos básicos que apoyan el empleo de esta terapia, la evidencia clínica actual sobre su beneficio. Señalamos los puntos controversiales y las perspectivas sobre su empleo y utilidad a corto y largo plazo.
Ischemic heart disease is the leading cause of death and heart failure worldwide. That is why it is important to develop new therapeutic modalities to decrease mortality and long-term complications in these patients. One of the main lines of research worldwide is myocardial regeneration, using progenitor cells in order to improve systolic and diastolic function in patients with ischemic heart disease, as well as to increase their survival. There have been carried out, with great enthusiasm worldwide, human and animal studies to define the usefulness of stem cells in the management of patients with ischemic heart disease. Today, regenerative therapy in ischemic heart disease is considered a novel therapeutic tool, with substantial theoretical benefits and few side effects. Here we present the scientific principles that support the use of this therapy, discuss the current clinical evidence available; and point out the controversial issues still not clarified on its use and usefulness in the short and long term.
Asunto(s)
Humanos , Isquemia Miocárdica/cirugía , Trasplante de Células Madre , Ensayos Clínicos como AsuntoRESUMEN
El infarto agudo del miocardio de origen embólico presenta una incidencia del 5-13 por ciento; se asocia a factores de riesgo de embolia sistémica. El mecanismo del infarto tiene similitud con el infarto de origen aterosclerótico, por lo que es suceptible de tratamiento con trombolisis. Se reportan 3 casos de pacientes con cardiopatía reumática inactiva, coartación de aorta y prótesis valvular mecánica, como probables causas de infarto embólico, de localización posteroinferior con estensión dorsal y a quienes se les administró estreptoquinasa intravenosa. Los pacientes presentaron criterios de reperfusión miocárdica; presentándose en dos, angor post-infarto. El primero presentó reoclusión de la coronaria derecha, llevandolo a colocación de hemoducto venoso. En el segundo se observó la persistencia de trombo en la arteria circunfleja, dejándole con anticoagulación por tres meses y en el tercer caso no se observó lesiones coronarias. Se concluye que la terapia trombolíca con estreptoquinasa en el infarto agudo del miocardio embólico previene la progresión del daño isquémico y favorece la evolución clínica del paciente. Además, debe sospecharse tal enfermedad en pacientes que presentan factores de risgo para embolia sistémica y arterias coronarias normales con obstrucción de un solo vaso