Rivaroxaban versus warfarin in postoperative atrial fibrillation: Cost-effectiveness analysis in a single-center, randomized, and prospective trial.

Objectives: Postoperative atrial fibrillation is the most common clinical complication after coronary artery bypass graft surgery. It is associated with a high risk of both stroke and death and increases the length of hospital stay and costs. This study aimed to evaluate anticoagulants in postoperative atrial fibrillation. Methods: A single-center, randomized, prospective, and open-label study. The trial was conducted in Heart Institute at University of São Paulo, Brazil. Patients who developed postoperative atrial fibrillation were randomized to anticoagulation with rivaroxaban or warfarin plus enoxaparin bridging. The primary objective was the cost-effectiveness evaluated by quality-adjusted life years, using the SF-6D questionnaire. The secondary end point was the combination of death, stroke, myocardial infarction, thromboembolic events, infections, bleeding, readmissions, and surgical reinterventions. The safety end point was any bleeding using the International Society on Thrombosis and Haemostasis score. Follow-up period was 30 days after hospital discharge. Results: We analyzed 324 patients and 53 patients were randomized. The median cost-effectiveness was $1423.20 in the warfarin group versus $586.80 in the rivaroxaban group (P = .002). The median cost was lower in the rivaroxaban group, $450.20 versus $947.30 (P < .001). The secondary outcome was similar in both groups, 44.4% in warfarin group versus 38.5% in the rivaroxaban group (P = .65). Bleeding occured in 25.9% in the warfarin group versus 11.5% in the rivaroxaban group (P = .18). Conclusions: Rivaroxaban was more cost-effective when compared with warfarin associated with enoxaparin bridging in postoperative atrial fibrillation after isolated coronary artery bypass grafting.

Occurrence of recently diagnosed atrial fibrillation in the immediate postoperative period of myocardial revascularization surgery. Although common, a devalued complication.

Atrial fibrillation (AF) is the most common arrhythmia in the postoperative period of cardiac surgery, with a prevalence between 15-40% after coronary artery bypass surgery (CABG). Several strategies have been tested for the prevention and management of AF postoperatively. Previous studies and analysis of records have shown higher rates of hospitalization and clinical outcomes associated with this entity, including increased mortality in the short- and long-term. This perspective reviews the topic, and offers recommendations for the management of this arrhythmia in the postoperative period of CABG, with a special focus on anticoagulation strategies.

Association of Longitudinal Values of Glycated Hemoglobin With Cardiovascular Events in Patients With Type 2 Diabetes and Multivessel Coronary Artery Disease.

Importance: Glycated hemoglobin (HbA1c) values are used to guide glycemic control, but in patients with type 2 diabetes and multivessel coronary artery disease (CAD), the association of the longitudinal values of HbA1c with cardiovascular outcomes is unclear. Objective: To assess whether longitudinal variation of HbA1c is associated with cardiovascular events in long-term follow-up among patients with diabetes and multivessel CAD. Design, Setting, and Participants: This cohort study included 888 patients with type 2 diabetes and multivessel CAD in the Medicine, Angioplasty, or Surgery Study (MASS) Registry of the Heart Institute of the University of São Paulo from January 2003 to December 2007. Data were analyzed from January 15, 2018, to October 15, 2019. Exposure: Longitudinal HbA1c values. Main Outcomes and Measures: The combined outcome of all-cause mortality, myocardial infarction, and ischemic stroke. Results: Of 888 patients with type 2 diabetes and multivessel CAD, 725 (81.6%; median [range] age, 62.4 [55.7-68.0] years; 467 [64.4%] men) had complete clinical and HbA1c information during a median (interquartile range) follow-up period of 10.0 (8.0-12.3) years, with a mean (SD) of 9.5 (3.8) HbA1c values for each patient. The composite end point of death, myocardial infarction, or ischemic stroke occurred in 262 patients (36.1%). A 1-point increase in the longitudinal value of HbA1c was significantly associated with a 14% higher risk of the combined end point of all-cause mortality, myocardial infarction, and ischemic stroke (hazard ratio, 1.14; 95% CI, 1.04-1.24; P = .002) in the unadjusted analysis. After adjusting for baseline factors (ie, age, sex, 2-vessel or 3-vessel CAD, initial CAD treatments, ejection fraction, and creatinine and low-density lipoprotein cholesterol levels), a 1-point increase in the longitudinal value of HbA1c was associated with a 22% higher risk of the combined end point (hazard ratio, 1.22; 95% CI, 1.12-1.35; P < .001). Conclusions and Relevance: Longitudinal increase of HbA1c was independently associated with higher rates of cardiovascular events in patients with type 2 diabetes and multivessel CAD.

Clinical characteristics and long-term progression of young patients with acute coronary syndrome in Brazil.

OBJECTIVE: In Brazil, there are few descriptions in the literature on the angiographic pattern and clinical characteristics of young patients with acute coronary syndrome, despite the evident number of cases in the population. The objective of this study was to evaluate which clinical characteristics are most closely related to the acute coronary syndrome in young patients, and what long-term outcomes are in this population. METHODS: This is a prospective observational study with 268 patients aged under 55 years with acute coronary syndrome, carried out between May 2010 and May 2013. Data were obtained on demographics, laboratory test and angiography results, and the coronary treatment adopted. Statistical analysis was presented as percentages and absolute values. RESULTS: Approximately 57% were men and the median age was 50 years (30 to 55). The main risk factors were arterial hypertension (68%), smoking (67%), and dyslipidemia (43%). Typical pain was present in 90% of patients. In young individuals, 25.7% showed ST segment elevation. Approximately 56.5% of patients presented with a single-vessel angiographic pattern. About 7.1% were submitted to coronary bypass surgery, and 42.1% to percutaneous coronary angioplasty. Intrahospital mortality was 1.5%, and the combined event rate (cerebrovascular accident/stroke, cardiogenic shock, reinfarction, and arrhythmias) was 13.8%. After a mean follow-up of 10 months, mortality was 9.8%, while 25.4% of the patients had new ischemic events, and 37.3% required readmission to hospital. CONCLUSION: In the short-term, young patients presented with mortality rates below what was expected when compared to the rates noted in other studies. However, there was a significant increase in the number of events in the 10-month follow-up.

Long-term analysis of left ventricular ejection fraction in patients with stable multivessel coronary disease undergoing medicine, angioplasty or surgery: 10-year follow-up of the MASS II trial.

BACKGROUND: Assuming that coronary interventions, both coronary bypass surgery (CABG) and percutaneous coronary intervention (PCI), are directed to preserve left ventricular function, it is not known whether medical therapy alone (MT) can achieve this protection. Thus, we evaluated the evolution of LV ejection fraction (LVEF) in patients with stable coronary artery disease (CAD) treated by CABG, PCI, or MT as a post hoc analysis of a randomized controlled trial with a follow-up of 10 years. METHODS: Left ventricle ejection fraction was assessed with transthoracic echocardiography in patients with multivessel CAD, participants of the MASS II trial before randomization to CABG, PCI, or MT, and re-evaluated after 10 years of follow-up. RESULTS: Of the 611 patients, 422 were alive after 10.32 ± 1.43 years. Three hundred and fifty had LVEF reassessed: 108 patients from MT, 111 from CABG, and 131 from PCI. There was no difference in LVEF at the beginning (0.61 ± 0.07, 0.61 ± 0.08, 0.61 ± 0.09, respectively, for PCI, CABG, and MT, P = 0.675) or at the end of follow-up (0.56 ± 0.11, 0.55 ± 0.11, 0.55 ± 0.12, P = 0.675), or in the decline of LVEF (reduction delta of -7.2 ± 17.13, -9.08 ± 18.77, and -7.54 ± 22.74). Acute myocardial infarction (AMI) during the follow-up was associated with greater reduction in LVEF. The presence of previous AMI (OR: 2.50, 95% CI: 1.40-4.45; P = 0.0007) and during the follow-up (OR: 2.73, 95% CI: 1.25-5.92; P = 0.005) was associated with development of LVEF <45%. CONCLUSION: Regardless of the therapeutic option applied, LVEF remains preserved in the absence of a major adverse cardiac event after 10 years of follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Registration number ISRCTN66068876.

Hypotheses, rationale, design, and methods for prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifest myocardial infarction. A comparative analysis of biomarkers and cardiac magnetic resonance. The MASS-V Trial.

BACKGROUND: Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis. METHODS/DESIGN: The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR. DISCUSSION: The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.

Efficacy of aneurysmectomy in patients with severe left ventricular dysfunction: favorable short-and long-term results in ischemic cardiomyopathy.

INTRODUCTION: The purpose of this study was to (1) identify the functional results after aneurysm surgery in patients with ischemic cardiomyopathy and (2) identify predictors of favorable outcomes. METHODS AND MATERIAL: Patients (n = 169) with angiographic left ventricular ejection fraction of 22 ± 5% underwent aneurysm surgery and were prospectively followed for three years. Prior to surgery, 40% and 60% of the patients were in congestive heart failure NYHA class I/II and III/IV, respectively. Concomitant revascularization was performed on 95% of the patients. RESULTS: Cumulative in-hospital and 36-month mortalities were 7% and 15%, respectively. These respective rates varied according to preoperative parameters: CHF class I-II, 4% and 13%; CHF class III-IV, 8% and 16%; LVEF,20%, 12% and 26%; LVEF 21-30%, 2% and 6%; gated LVEF exercise/rest .5%, ,1% and 4%; and gated LVEF exercise/rest #5%, 17% and 38%. Higher LVEF ex/rest ratio (p = 0.01), male sex (p = 0.05), and a higher number of grafts (p = 0.01) were predictive of improvement in CHF class at follow-up based on the results of a multivariate analysis. After three years of follow-up, 84% of the patients were in class I/II, LVEF was 45 ± 7%, and gated LVEF ex/rest ratio was 13% higher (p,0.01) compared to the beginning of the study. CONCLUSIONS: These data suggest that aneurysmectomy among patients with severe LV dysfunction result in short and long-term favorable functional outcome and survival. Selection of appropriate surgical candidates may substantially improve survival rates among these patients.

Surgical myocardial revascularization of patients with ischemic cardiomyopathy and severe left ventricular disfunction.

OBJECTIVE: To determine long-term survival, identify preoperative factors predictive of a favorable outcome, and assess functional improvement after coronary artery bypass grafting in patients with advanced left ventricular dysfunction. METHODS: Between 1995 and 2001, 244 patients who underwent coronary artery bypass grafting and had a preoperative left ventricular ejection fraction less than or equal to 35% were included. left ventricular ejection fraction was determined by uniplanar or biplanar ventriculography during left heart catheterization. Indication for surgery was predominance of tissue viability. Functional improvement was evaluated through echocardiography and gated scintigraphy at exercise/rest. Survival was determined by Kaplan-Meier analysis. RESULTS: Mean left ventricular ejection fraction was 29+/-4% (ranged from 9% to 35%). An average of 3.01 coronary bypass grafts per patient were performed. In-hospital mortality was 3.7% (9 patients). The 4-year survival rate was 89.7%. Multivariate correlates of favorable short- and long-term outcome were preoperative New York Heart Association Funcional classification for congestive heart failure class I/II, lower PAsP, higher left ventricular ejection fraction and gated left ventricular ejection fraction Ex/Rest ratio >5%. Left ventricular ejection fraction rise from 32+/-5% to 39+/-5%, p <0.001. Gated left ventricular ejection fraction at exercise/rest increased markedly after surgery: from 27+/-8%/23+/-7% to 37+/-5%/31+/-6%, p <0.001. CONCLUSIONS: In selected patients with severe ischemic left ventricular dysfunction and predominance of tissue viability, coronary artery bypass grafting may be capable of implement preoperative clinical/functional parameters in predicting outcome as left ventricular ejection fraction and gated left ventricular ejection fraction at exercise/rest.

Effect of â-blockers on the risk of atrial fibrillation in patients with acute myocardial infarction

INTRODUCTION: Oral â-blockers improve the prognosis of patients with acute myocardial infarction, while atrial fibrillation worsens the prognosis of this population. The reduction of atrial fibrillation incidence in patients treated with â-blockers could at least in part explain the benefits of this drug. OBJECTIVE: To investigate the effect of â-blockers on the incidence of atrial fibrillation in patients with acute myocardial infarction. METHODS: We analyzed 1401 patients with acute myocardial infarction and evaluated the occurrence or absence of atrial fibrillation, the use of oral â-blockers and mortality during the first 24 hours. RESULTS: a) The use of â-blockers was inversely correlated with the presence of atrial fibrillation (ñ = 0.004; OR = 0.54). b) Correlations with mortality were as follows: 31.5 percent in patients with atrial fibrillation, 9.2 percent in those without atrial fibrillation (ñ < 0.001; Odds Ratio = 4.52), and 17.5 percent in patients not treated with â-blockers and 6.7 percent in those who received the drug (ñ < 0.001; OR = 0.34). c) Adjusted Models: The presence of atrial fibrillation was independently correlated with mortality (OR = 2.48, ñ = 0.002). The use of â-blockers was inversely and independently correlated with mortality (OR = 0.53; ñ = 0.002). The patients who used â-blockers showed a lower risk of atrial fibrillation (OR = 0.59; ñ = 0.029) in the adjusted model. CONCLUSION: The presence of atrial fibrillation and the absence of oral â-blockers increased in-hospital mortality in patients with acute myocardial infarction. Oral â-blockers reduced the incidence of atrial fibrillation, which might be at least partially responsible for the drug's benefit.

Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory activity in patients with coronary artery disease--a randomized placebo-controlled study.

The balance between different immunological stimuli is essential in the progression and stabilization of atherosclerotic plaques. Immune regulation has been suggested as potential target for the treatment of atherosclerotic disease. We sought to determine whether treatment with pentoxifylline, a phosphodiesterase inhibitor with immunomodulating properties, could reduce the pro-inflammatory response observed in patients with acute coronary syndromes (ACS) and increase anti-inflammatory activity. In a double-blind, prospective, placebo-controlled study, 64 patients with ACS were randomized to receive pentoxifylline 400mg TID or placebo for 6 months. Analysis of the pro-inflammatory markers, C-reactive protein (CRP), interleukin (IL)-6, IL-12, interferon-gamma and tumor necrosis factor (TNF)-alpha and the anti-inflammatory cytokines, transforming growth factor (TGF)-beta1 and IL-10 were done at baseline, 1 and 6 months. Pentoxifylline treatment significantly reduced the adjusted levels of CRP and TNF-alpha compared to placebo after 6 months (P=0.04 and P<0.01, respectively). IL-12 increase was significantly less pronounced with pentoxifylline (P=0.04). The levels of the anti-inflammatory cytokine, IL-10, also declined significantly less in the pentoxifylline group compared to placebo (P<0.01) with a trend towards a higher increase of TGF-beta1 in the former group (P=0.16). Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory response in patients with ACS and may have beneficial clinical effects on cardiovascular events.

The influence of health insurance plans on the long term outcome of patients with acute myocardial infarction.

BACKGROUND: Little is known, especially in our country, about the influence of health insurance plans on the long term outcome of patients after acute myocardial infarction (AMI). OBJECTIVE: To assess the outcome of patients with AMI who are covered by the National Health System (SUS) or other health insurance plans. METHODS: We analyzed 1,588 patients with AMI (mean age of 63.3 + 12.9 years, 71.7% male) who were included prospectively into a specific database and followed up for up to 7.55 years. Of this total, 1,003 were placed in the "SUS" group and 585 in the "other insurance plans" group. We applied chi-square, log-rank and Cox (stepwise) to the different statistical analyses. The long term multivariate model with mortality as a dependent variable included 18 independent variables. RESULTS: In-hospital mortality rates in the "other insurance plans" and "SUS" groups were 11.4% and 10.3%, respectively (p = 0.5); in the long term, survival chances in the groups were respectively, 70.4% + 2.9 and 56.4% + 4.0 (p = 0.001, hazard-ratio = 1.43, or a 43% higher chance of death in the "SUS" group). In the adjusted model, the 'SUS' group had a significantly higher chance of death (a 36% higher chance, p = 0.005). Surgical revascularization and angioplasty improved the prognosis of these patients, whereas age and previous history of infarction, diabetes or heart failure worsened the prognosis. CONCLUSIONS: Relative to patients with other insurance plans, SUS users present similar mortality rates during hospital stay, but their prognosis is worse in the long term, thus reinforcing the need for additional efforts to improve the care provided to these patients after hospital discharge.