Polypill Strategy in Secondary Cardiovascular Prevention.

BACKGROUND: A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODS: In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTS: A total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups. CONCLUSIONS: Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.).

Thirteen-year trends in hospitalization and outcomes of patients with heart failure in Spain.

BACKGROUND: Heart failure is one of the most pressing current public health concerns. However, in Spain there is a lack of population data. We aimed to examine thirteen-year nationwide trends in heart failure hospitalization, in-hospital mortality and 30-day readmission rates in Spain. METHODS: We conducted a retrospective observational study of patients discharged with the principal diagnosis of heart failure from The National Health System' acute hospitals during 2003-2015. The source of the data was the Minimum Basic Data Set. Temporal trends were modelled using Poisson regression analysis. The risk-standardized in-hospital mortality ratio was calculated using a multilevel risk adjustment logistic regression model. RESULTS: A total of 1 254 830 episodes of heart failure were selected. Throughout 2003-2015, the number of hospital discharges with principal diagnosis of heart failure increased by 61%. Discharge rates weighted by age and sex increased during the period [incidence rate ratio (IRR): 1.03; 95% confidence interval (95% CI): 1.03-1.03; P < .001)], although this increase was motivated by the increase in older age groups (≥75 years old). The crude mortality rate diminished (IRR: 0.99; 95% CI: 0.98-1, P < .001), but 30-day readmission rate increased (IRR: 1.05; 95% CI: 1.04-1.06; P < .001). The risk-standardized in-hospital mortality ratio did not change throughout the study period (IRR: 0.997; 95% CI: 0.992-1; P = .32). CONCLUSIONS: From 2003 to 2015, heart failure admission rates increased significantly in Spain as a consequence of the sustained increase of hospitalization in the population ≥75 years. 30-day readmission rates increased, but the risk-standardized in-hospital mortality ratio did not significantly change for the same period.

Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study.

INTRODUCTION AND OBJECTIVES: To compare the long-term results of direct oral anticoagulants (DOAC) vs vitamin K antagonists (VKA) in real-world-patients with nonvalvular atrial fibrillation (NVAF) in a nationwide, prospective study. METHODS: The FANTASIIA registry prospectively included outpatients with AF anticoagulated with DOAC or VKA (per protocol, proportion of VKA and DOAC 4:1), consecutively recruited from June 2013 to October 2014 in Spain. The incidence of major events was analyzed and compared according to the anticoagulant treatment received. RESULTS: A total of 2178 patients were included in the study (mean age 73.8±9.4 years), and 43.8% were women. Of these, 533 (24.5%) received DOAC and 1645 (75.5%) VKA. After a median follow up of 32.4 months, patients receiving DOAC vs those receiving VKA had lower rates of stroke-0.40 (95%CI, 0.17-0.97) vs 1.07 (95%CI,0.79-1.46) patients/y, P=.032-, severe bleedings-2.13 (95%CI, 1.45-3.13) vs 3.28 (95%CI, 2.75-3.93) patients/y; P = .044-, cardiovascular death-1.20 (95%CI, 0.72-1.99) vs 2.45 (95%CI, 2.00-3.00) patients/y; P = .009-, and all-cause death-3.77 (95%CI, 2.83-5.01) vs 5.54 (95%CI, 4.83-6.34) patients/y; P = .016-. In a modified Cox regression model by the Andersen-Gill method for multiple events, hazard ratios for patients receiving DOAC were: 0.42 (0.16-1.07) for stroke; 0.47 (0.20-1.16) for total embolisms; 0.76 (0.50-1.15) for severe bleedings; 0.67 (0.39-1.18) for cardiovascular death; 0.86 (0.62-1.19) for all-cause death, and 0.82 (0.64-1.05) for the combined event consisting of stroke, embolism, severe bleeding, and all-cause death. CONCLUSIONS: Compared with VKA, DOAC is associated with a trend to a lower incidence of all major events, including death, in patients with NVAF in Spain.

[HDL cholesterol and high-sensitive troponin T as predictive biomarkers of atrial fibrillation after heart surgery]. / Colesterol HDL y troponina T ultrasensible como biomarcadores predictivos de fibrilación auricular postoperatoria.

INTRODUCTION: Atrial fibrillation (AF) has an incidence rate of approximately 30% and is the most frequent arrhythmia following heart surgery. Factors such as inflammation, the presence of heart fibrosis, stress and cardiomyocyte apoptosis, have all been associated with AF. OBJECTIVES: We believe that atrial remodelling is a pre-existent process in patients with post-surgical AF. We have analyzed the factors related to the incidence of atrial fibrillation in the period after heart surgery. METHODS: We included consecutive, hemodynamically stable patients with a sinusal rhythm who were subjected to programmed heart surgery with extracorporeal circulation. An assessment was made of the fall in atrial fibrillation after surgery using prolonged electrocardiographic monitoring. RESULTS: A total of 100 patients were included in the study and were subjected to either coronary revascularisation surgery (59) or aortic valve substitution due to severe aortic stenosis (41). Postoperative AF occurred in 29 patients who received predominantly more valve surgery than coronary surgery. The following factors were predictive of postoperative AF in the multivariate analysis: Male sex; beta-blocker therapy for chronic disease; the use of intraoperative; fibrinogen perfusion; low HDL cholesterol values; and high sensitive troponin T values, in the preoperative period. CONCLUSIONS: HDL cholesterol and high sensitive troponin T can be useful biomarkers to predict the occurrence of AF after surgery. The early identification of these patients who develop of FA allows us to take preventive measures to minimize the negative effects.

[Percutaneous transluminal angioplasty in patients with subclavian stenosis and internal mammary grafts]. / Angioplastia transluminal percutánea en pacientes con estenosis de la arteria subclavia e injertos de arteria mamaria.

Subclavian artery stenosis is an uncommon cause of myocardial ischaemia in patients with internal mammary artery grafts. Coronary subclavian steal and impaired flow through the graft are the two mechanisms implied. We report 2 patients with mammary artery grafts in whom reappraisal of anginal symptoms was related to the presence of proximal subclavian stenoses located just before the origin of the mammary artery grafts. Both patients were successfully treated by percutaneous angioplasty and stent implantation.

[Should we try to determine the specific cause of cardiac tamponade?]. / 'Debemos pensar en una etiología específica en pacientes con taponamiento cardíaco?

INTRODUCTION: The causes of cardiac tamponade vary and it has been suggested that underlying causes should be sought in all cases. The purpose of this study was to determine the causes of cardiac tamponade in our environment, distinguishing between specific and idiopathic causes, and analyzing the proportion and causes in the subgroup of patients with relapsing tamponade. PATIENTS AND METHOD: We retrospectively studied all patients who underwent therapeutic pericardiocentesis between 1985 and 2001. The clinical and radiographic features and macroscopic characteristics of the pericardial fluid were analyzed. The final diagnosis in each patient was based on the clinical history, follow-up, pericardial fluid cytology, and pericardial biopsy, if available. RESULTS: Ninety-six patients were included (52 men/44 women), mean age 56.1 16.1 years. The cause of pericardial effusion was neoplasm in 50 patients (52.1%), 14 idiopathic pericarditis (14.6%), 12 renal failure (12.5%), 7 iatrogenic cases (7.3%), 4 mechanical tamponades (4.2%), 2 tuberculosis (2.1%), and 7 other causes (7.3%). Thirty-five patients had relapsing tamponade; only 2 of them had idiopathic pericarditis (5.7%). We found no significant differences in age, development time, extracted volume or fluid features between tamponade of specific or idiopathic origin. CONCLUSIONS: Most of the cardiac tamponades in our series had a specific cause. This made it necessary to identify a specific underlying cause in each case, especially in relapsing effusions. However, we did not find any variable suggestive of the cause of the disease.

[The efficacy of scheduled cardioversion in atrial fibrillation. Comparison of two schemes of treatment: electrical versus pharmacological cardioversion]. / Eficacia de la cardioversión programada en la fibrilación auricular. Comparación de dos esquemas de tratamiento: cardioversión eléctrica frente a cardioversión farmacológica.

INTRODUCTION AND OBJECTIVES: Atrial fibrillation is an arrhythmia with high morbidity and mortality. Restoring sinus rhythm is one of the principle objectives in its management. The present study aimed to assess the efficacy of scheduled cardioversion on atrial fibrillation by comparing two different therapeutic approaches: electrical vs. pharmacological cardioversion. PATIENTS AND METHOD: Two hundred thirty patients with atrial fibrillation of more than 48 hours duration and requiring sinus rhythm restoration were included. One hundred forty-four patients underwent external electrical cardioversion and 86 patients received quinidine. We analyzed the rate of success, duration of hospital stay, complications and clinical and echocardiographic variable that might predict success. RESULTS: Sinus rhythm was restored in 181 of 230 patients (79%). The rate of success was 77% (111/144 patients) in the electrical group and 81% (70 of 86 patients) in the pharmacological group (ns). In 13 pharmacological group patients for whom the first attempt failed attempt, a second attempt with electrical cardioversion was made and was successful in 8 patients (61%). No embolic complication was recorded and only two electrical disturbances were seen. Only atrial fibrillation lasting less than 8 weeks was associated with a higher success rate (p < 0.01). CONCLUSIONS: Scheduled cardioversion in atrial fibrillation is an effective technique with a high success rate and a very low rate of complication. Electrical cardioversion and pharmacological cardioversion with quinidine are similarly effective, although the latter involves a longer hospital stay.

Colesterol HDL y troponina T ultrasensible como biomarcadores predictivos de fibrilación auricular postoperatoria / HDL cholesterol and high-sensitive troponin T as predictives biomarkers of atrial fibrillation after heart surgery

Introducción: La fibrilación auricular (FA), con una incidencia aproximada del 30%, es la arritmia más frecuente tras cirugía cardiaca. Se han asociado a la FA factores como la inflamación, la presencia de fibrosis cardiaca, el estrés y la apoptosis de cardiomiocitos. Objetivos: Consideramos que el remodelado auricular es un proceso preexistente en los pacientes con FA posquirúrgica. Analizamos los factores relacionados con la incidencia de FA en el postoperatorio de cirugía cardiaca. Métodos: Incluimos a pacientes consecutivos, estables hemodinámicamente y en ritmo sinusal, sometidos a cirugía cardiaca programada con circulación extracorpórea. Se valora la caída en FA posquirúrgica. Resultados: Se incluyeron un total de 100 pacientes sometidos a cirugía de revascularización coronaria (59) o sustitución valvular aórtica (41) por estenosis aórtica grave. La FA postoperatoria se produjo en 29 pacientes con predominio de la cirugía valvular respecto a la cirugía coronaria. Los factores predictivos de la aparición de FA postoperatoria en el análisis multivariable fueron el sexo masculino, la ausencia de terapia crónica con betabloqueadores, la perfusión de fibrinógeno intraoperatorio, valores bajos de colesterol HDL y valores elevados de troponina T ultrasensible en el preoperatorio. Conclusiones: El colesterol HDL y la troponina T ultrasensible pueden ser biomarcadores útiles para predecir la aparición de FA postoperatoria. La identificación precoz de estos pacientes nos permite adoptar medidas preventivas para minimizar sus efectos negativos.

Introduction: Atrial fibrillation (AF) has an incidence rate of approximately 30% and is the most frequent arrhythmia following heart surgery. Factors such as inflammation, the presence of heart fibrosis, stress and cardiomyocyte apoptosis, have all been associated with AF. Objectives: We believe that atrial remodelling is a pre-existent process in patients with post-surgical AF. We have analyzed the factors related to the incidence of atrial fibrillation in the period after heart surgery. Methods: We included consecutive, hemodynamically stable patients with a sinusal rhythm who were subjected to programmed heart surgery with extracorporeal circulation. An assessment was made of the fall in atrial fibrillation after surgery using prolonged electrocardiographic monitoring. Results: A total of 100 patients were included in the study and were subjected to either coronary revascularisation surgery (59) or aortic valve substitution due to severe aortic stenosis (41). Postoperative AF occurred in 29 patients who received predominantly more valve surgery than coronary surgery. The following factors were predictive of postoperative AF in the multivariate analysis: Male sex; beta-blocker therapy for chronic disease; the use of intraoperative; fibrinogen perfusion; low HDL cholesterol values; and high sensitive troponin T values, in the preoperative period. Conclusions: HDL cholesterol and high sensitive troponin T can be useful biomarkers to predict the occurrence of AF after surgery. The early identification of these patients who develop of FA allows us to take preventive measures to minimize the negative effects.

QRS duration and early hemodynamic instability after coronary revascularization surgery.

INTRODUCTION AND OBJECTIVES: The duration of the QRS interval measured by ECG is a marker of ventricular dysfunction and indicates a poor prognosis. Its value in patients undergoing coronary revascularization surgery has not been established. METHODS: The study involved 203 consecutive patients (age 64+/-9 years, 74% male) scheduled for elective coronary surgery. The maximum QRS duration measured on a preoperative 12-lead ECG was recorded. Hemodynamic instability was defined as the occurrence of cardiac death, heart failure, or a need for intravenous inotropic drugs or intra-aortic balloon counterpulsation during the postoperative period. RESULTS: The occurrence of hemodynamic instability (n=94, 46%) was associated with a longer preoperative QRS duration (97.5+/-21.14 ms vs 88.5+/-16.9 ms; P=.001). The QRS duration was also longer in patients who developed heart failure (n=23; 104.3+/-22.9 ms vs. 91.1+/-18.5 ms; P=.002), needed inotropic drugs (n=77; 96.5+/-20.5 ms vs. 90.1+/-18.2 ms; P=.007) or developed postoperative atrial fibrillation (n=58; 98.2+/-23.8 ms vs. 90.4+/-17.0 ms; P=.018). Bundle branch block was associated with a greater need for intra-aortic balloon counterpulsation (29% vs 12%; P=.012) or inotropic drugs (58% vs 35%; P=.014) and a higher incidence of hemodynamic instability (69% vs 42%; P=.006). Multivariate analysis identified the following independent predictors of hemodynamic instability: QRS duration (adjusted odds ratio [OR] per 10 ms=1.49; 95% confidence interval [CI], 1.11-2; P=.007), the lack of an arterial graft (OR=3.6; 95% CI, 1.14-11.6; P=.029) and extracorporeal circulation time (OR per min=1.013; 95% CI, 1.003-1.023; P=.013). CONCLUSIONS: The intraventricular conduction delay, or QRS duration, was associated with a higher risk of postoperative hemodynamic instability following coronary surgery.