Rivaroxaban with or without aspirin in stable cardiovascular disease

BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=-4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group...

Exercise may cause myocardial ischemia at the anaerobic threshold in cardiac rehabilitation programs.

Myocardial ischemia may occur during an exercise session in cardiac rehabilitation programs. However, it has not been established whether it is elicited when exercise prescription is based on heart rate corresponding to the anaerobic threshold as measured by cardiopulmonary exercise testing. Our objective was to determine the incidence of myocardial ischemia in cardiac rehabilitation programs according to myocardial perfusion SPECT in exercise programs based on the anaerobic threshold. Thirty-nine patients (35 men and 4 women) diagnosed with coronary artery disease by coronary angiography and stress technetium-99m-sestamibi gated SPECT associated with a baseline cardiopulmonary exercise test were assessed. Ages ranged from 45 to 75 years. A second cardiopulmonary exercise test determined training intensity at the anaerobic threshold. Repeat gated-SPECT was obtained after a third cardiopulmonary exercise test at the prescribed workload and heart rate. Myocardial perfusion images were analyzed using a score system of 6.4 at rest, 13.9 at peak stress, and 10.7 during the prescribed exercise (P < 0.05). The presence of myocardial ischemia during exercise was defined as a difference > or = 2 between the summed stress score and summed rest score. Accordingly, 25 (64%) patients were classified as ischemic and 14 (36%) as nonischemic. MIBI-SPECT showed myocardial ischemia during exercise within the anaerobic threshold. The 64% prevalence of ischemia observed in the study should not be looked on as representative of the whole population of patients undergoing exercise programs. Changes in patient care and exercise programs were implemented as a result of our finding of ischemia during the prescribed exercise.

Exercise may cause myocardial ischemia at the anaerobic threshold in cardiac rehabilitation programs

Myocardial ischemia may occur during an exercise session in cardiac rehabilitation programs. However, it has not been established whether it is elicited when exercise prescription is based on heart rate corresponding to the anaerobic threshold as measured by cardiopulmonary exercise testing. Our objective was to determine the incidence of myocardial ischemia in cardiac rehabilitation programs according to myocardial perfusion SPECT in exercise programs based on the anaerobic threshold. Thirty-nine patients (35 men and 4 women) diagnosed with coronary artery disease by coronary angiography and stress technetium-99m-sestamibi gated SPECT associated with a baseline cardiopulmonary exercise test were assessed. Ages ranged from 45 to 75 years. A second cardiopulmonary exercise test determined training intensity at the anaerobic threshold. Repeat gated-SPECT was obtained after a third cardiopulmonary exercise test at the prescribed workload and heart rate. Myocardial perfusion images were analyzed using a score system of 6.4 at rest, 13.9 at peak stress, and 10.7 during the prescribed exercise (P < 0.05). The presence of myocardial ischemia during exercise was defined as a difference ≥2 between the summed stress score and summed rest score. Accordingly, 25 (64 percent) patients were classified as ischemic and 14 (36 percent) as nonischemic. MIBI-SPECT showed myocardial ischemia during exercise within the anaerobic threshold. The 64 percent prevalence of ischemia observed in the study should not be looked on as representative of the whole population of patients undergoing exercise programs. Changes in patient care and exercise programs were implemented as a result of our finding of ischemia during the prescribed exercise.

Cardiovascular disease in South America: current status and opportunities for prevention.

South America comprises widely different environments consisting of many complex and heterogeneous ethnicities, societies and cultures. During recent decades conspicuous advances in human and societal development have been made. South America now faces three major demographic shifts: population growth; urbanisation (almost 90% of the population live in urban areas) and ageing. Recently, an epidemiological transition has been seen. Urbanisation has brought unfavourable and prominent changes, such as increased smoking rates, stress, lack of physical activity and poor diets (more fat and calories). Consequently, owing to the interaction between environment and genetic susceptibility, the modifications induced by urbanisation have resulted in enhancement of the cardiovascular risk factors and cardiovascular disease (CVD). This situation is responsible for the burden of CVD in South America, requiring effective action towards better detection and control of cardiovascular risk factors aimed at reducing the burden of disease in the region, which tends to be higher and increasingly serious.

Dados atuais de prevalência de fatores de risco cardiovascular entre populações de áreas urbana e rural do estudo PURE no Brasil / Actuals data of cardiovascular risk factors prevalence between populations of urbam and rural areas from PURE study in Brazil

O estudo PURE representa um dos maiores estudos de corte, envolvendo 150.000 indivíduos de áreas urbanas e rurais de 15 países. A má adaptação à urbanização, representada por variações no estilo de vida, fatores psicossociais e renda são determinantes independentes de fatores de risco cardiovascular

Acute precipitants of congestive heart failure exacerbations.

BACKGROUND: Few studies have prospectively and systematically explored the factors that acutely precipitate exacerbation of congestive heart failure (CHF) in patients with left ventricular dysfunction. Knowledge of such factors is important in designing measures to prevent deterioration of clinical status. The objective of this study was to prospectively describe the precipitants associated with exacerbation of CHF status in patients enrolled in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction Pilot Study. METHODS: We conducted a 2-stage, multicenter, randomized trial in 768 patients with CHF who had an ejection fraction of less than 40%. Patients were randomly assigned to receive enalapril maleate, candesartan cilexetil, or both for 17 weeks, followed by randomization to receive metoprolol succinate or placebo for 26 weeks. Investigators systematically documented information on clinical presentation, management, and factors associated with the exacerbation for any episode of acute CHF during follow-up. RESULTS: A total of 323 episodes of worsening of CHF occurred in 180 patients during 43 weeks of follow-up; 143 patients required hospitalization, and 5 died. Factors implicated in worsening of CHF status included noncompliance with salt restriction (22%); other noncardiac causes (20%), notably pulmonary infectious processes; study medications (15%); use of antiarrhythmic agents in the past 48 hours (15%); arrhythmias (13%); calcium channel blockers (13%); and inappropriate reductions in CHF therapy (10%). CONCLUSIONS: A variety of factors, many of which are avoidable, are associated with exacerbation of CHF. Attention to these factors and patient education are important in the prevention of CHF deterioration.

Prognostic factors of the results of cardiopulmonary resuscitation in a cardiology hospital.

OBJECTIVE: To analyze the early and late results of cardiopulmonary resuscitation in a cardiology hospital and to try to detect prognostic determinants of both short- and long-term survival. METHODS: A series of 557 patients who suffered cardiorespiratory arrest (CRA) at the Dante Pazzanese Cardiology Institute over a period of 5 years was analyzed to examine factors predicting successful resuscitation and long-term survival. RESULTS: Ressuscitation maneuvers were tried in 536 patients; 281 patients (52.4%) died immediately, and 164 patients (30.6%) survived for than 24 hours. The 87 patients who survived for more than 1 month after CRA were compared with nonsurvivors. Coronary disease, cardiomyopathy, and valvular disease had a better prognosis. Primary arrhythmia occurred in 73.5% of the >1-month survivor group and heart failure occurred in 12.6% of this group. In those patients in whom the initial mechanism of CRA was ventricular fibrillation, 33.3% survived for more than 1 month, but of those with ventricular asystole only 4.3% survived. None of the 10 patients with electromechanical dissociation survived. There was worse prognosis in patients included in the extreme age groups (zero to 10 years and 70 years or more). The best results occurred when the cardiac arrest took place in the catheterization laboratories. The worst results occurred in the intensive care unit and the hemodialysis room. CONCLUSION: The results in our series may serve as a helpful guide to physicians with the difficult task of deciding when not to resuscitate or when to stop resuscitation efforts.

The Organization to Assess Strategies for Ischemic Syndromes (OASIS) registry in patients with unstable angina.

Clinical approaches to the prevention of the potentially catastrophic consequences of coronary ischemic phenomena such as unstable angina and suspected non-Q-wave myocardial infarction (MI) differ across the world. In addition to prevailing physician beliefs in different societies, the level of access to catheterization laboratories largely determines whether an interventionist or conservative strategy is adopted. The Organization to Assess Strategies for Ischemic Syndromes (OASIS)--a prospective registry of approximately 8,000 patients with acute myocardial ischemia with no ST elevation, treated in 95 hospitals across 6 countries--furnished a unique window into regional differences in clinical management and the frequency and timing of invasive procedures (i.e., angiography, percutaneous transluminal coronary angioplasty [PTCA], and coronary artery bypass graft [CABG] surgery), as well as the outcomes of these trends. At 6 months after symptom onset, patients in the United States and Brazil, where the catheterization laboratory facilities are more accessible, underwent significantly (p <0.001) more angiography (69.4%), PTCA (23.6%), and CABG (25.2%) than in Canada and Australia, where the corresponding rates were 48.4%, 17.0%, and 16.8% (p <0.001), respectively; and in Hungary and Poland, where the respective rates were 23.5%, 5.8%, and 10.9% (p <0.001). This relatively aggressive approach led at 6 months to a more substantial decrease in refractory angina in the United States and Brazil than in Canada and Australia (20.4% vs 13.9%; p <0.001), but no improvement in rates of cardiovascular mortality and MI (10.5% versus 10.5%; p = 0.36). There was a significant (p < or = 0.012) increase in stroke, (1.9% vs 1.3%; p = 0.010) and major bleeding (1.9% vs 1.1%; p = 0.009) events. Furthermore, an inverse correlation emerged between baseline cardiovascular risk status and frequency of angiography and PTCA interventions preferentially for low-risk compared with high-risk patients. In concert with findings from other recent randomized trials, the OASIS Registry data suggest that although there are fewer hospital readmissions for unstable angina, there is a trend toward increased rates of death, MI, and stroke. These data urge a cautious approach to the use of invasive procedures in patients with unstable angina unless future trials demonstrate a clear benefit with an aggressive approach.

Metabolic modulation of acute myocardial infarction. The ECLA (Estudios Cardiológicos Latinoamérica) Collaborative Group.

BACKGROUND: Several trials have been performed in the past using glucose, insulin, and potassium infusion (GIK) for the treatment of acute myocardial infarction (AMI). Because of continuing uncertainty about the potential role of this therapeutic intervention, we conducted a randomized trial to evaluate the impact of a GIK solution during the first hours of AMI. METHODS AND RESULTS: Four hundred seven patients with suspected AMI admitted within 24 hours of symptoms onset were enrolled. In a ratio of 2:1, 268 patients were allocated to receive GIK (high- or low-dose) and 139 to receive control. Phlebitis and serum changes in the plasma concentration of glucose or potassium were observed more often with GIK. A trend toward a nonsignificant reduction in major and minor in-hospital events was observed in patients allocated to GIK. In 252 patients (61.9%) treated with reperfusion strategies, a statistically significant reduction in mortality (relative risk [RR] 0.34; 95% CI: 0.15 to 0.78; 2P=0.008) and a consistent trend toward fewer in-hospital events in the GIK group were observed. CONCLUSIONS: Our results confirm that a metabolic modulation strategy in the first hours of an AMI is feasible, applicable worldwide, and has mild side effects. The statistically significant mortality reduction in patients who underwent a reperfusion strategy might have important implications for the management of AMI patients. It is now essential to perform a large-scale trial to reliably determine the magnitude of benefit.

[Value of the use of milrinone in the treatment of acute crisis in patients with congestive heart failure]. / Valor do uso da milrinona no tratamento das crises de agudização em portadores de insuficiência cardíaca congestiva.

PURPOSE: To assess the hemodynamic effects of milrinone in a 48h intravenous infusion in patients with severe congestive heart failure (CHF) (NYHA class III or IV). METHODS: Forty patients with CHF were sequentially evaluated. Right heart catheterization was performed in order to measure, before and after administration of milrinone, several hemodynamic parameters (cardiac index, pulmonary wedge pressure, systemic and pulmonary vascular resistance). RESULTS: There was a significant improvement in hemodynamic parameters (cardiac index, cardiac output), and a decrease in systemic vascular resistance and pulmonary vascular resistance. Serious side effects were not observed in these patients. CONCLUSION: These findings indicate that milrinone is effective in the treatment of deteriorating phases of CHF and suggest that milrinone should be used in these select patients.

[Brazilian study with alteplase in acute myocardial infarction--EBRALT]. / Estudo Brasileiro com alteplase no infarto agudo do miocárdio--EBRALT.

PURPOSE: Prospective evaluation of the effects of the intravenous administration of rt-PA (Alteplase) up to 6 hours after the pain onset on the patency of the AMI related artery, mortality, adverse reactions and complications. METHODS: Open, multicenter, non-comparative study involving 139 patients with diagnosis of AMI, with less than 6h of duration. The rt-PA was intravenously administered, in a dose of 100mg, as follows: 10mg in the 1st 2min, 50mg in 58min and 40mg in 120min. In addition, the patients received intravenous heparin (5000 IU at first and then, 1000 IU/hour, for 24h), aspirin (500mg in the 1st day and then, 100mg/day) and dipyridamole (75mg, three times a day), during the hospitalization period. The angiographic study was performed in 129 (93%) patients, within the 1st week of AMI. RESULTS: The age of the patients ranged from 29 to 85 (mean 56.6 +/- 10.3) years. The related artery for the AMI was patent (TIMI II and III flow) in 92/129 (71%) patients, with a mean ejection fraction of 50 +/- 14%, a value higher than that exhibited by patients with TIMI 0 and I flow (average ejection fraction = 44 +/- 14%). Reinfarction was diagnosed in 9 (6.4%) patients during the hospitalization period. During this period, there were 9 (6.4%) deaths. Minor hemorrhages were observed in 19 (12%) patients and major hemorrhages in 3 (2%) cases. No patient experienced stroke. CONCLUSION: The administration of the rt-PA therapy in the AMI was associated to a high reperfusion index of the related artery for the infarction, with improved left ventricular function and low incidence of reinfarction and in-hospital mortality, as well as, complications.

[Surgical treatment of infective endocarditis]. / Tratamento cirúrgico na endocardite infecciosa.

PURPOSE: To analyse, retrospectively, 83 patients with infective endocarditis (IE) that were operated during the acute phase of the disease and to identify possible subgroups with distinct mortality. METHODS: Between 1985 to 1990, 83 patients comprised the subject of this analysis. Fifty-one (61%) were male, aged between 3 months to 71 years, mean of 31.4 +/- 16.7 years. RESULTS: We could identify two subgroups that were most frequently operated on: the left side IE and the Staphylococcus aureus; and 77 (43%) had left sided IE (p < 0.001). When discriminated accordingly to the specifically etiologic agent (Staphylococcus aureus) this difference continues to be statistically significant: of 29 left sided IE by this agent 13 (45%) were operated on, whereas from 22 right sided IE by the same agents, just 3 (14%) were operated on (p < 0.05). The two major etiologic agents did not show any statistically significant difference in the number of patients that needed to be operated on: on those 51 patients with Staphylococcus aureus IE, 16 (31%) were treated surgically, while from the 60 patients with Streptococcus viridans, 22 (37%) underwent to surgical procedure (p- NS). The mortality in the patients treated by surgery was 32%, and those with Staphylococcus aureus IE were responsible for 46% of the total surgical deaths. CONCLUSION: Surgical treatment were most frequently used in the patient with left sided IE independently of the etiologic agent.

[Infective endocarditis in children and adolescents]. / Endocardite infecciosa na infância e adolescência.

PURPOSE: To assess infective endocarditis (IE) predisposing factors, etiologic agents and hospital course in infants and adolescents. METHODS: We Studied 222 patients admitted under compatible IE diagnosis, from 1985 to 1990. The population of this study is fifty patients (23%) under 16 years of age. RESULTS: Rheumatic valvular disease, as predisposing cardiopathy was proeminent within 9 to 16 years of age, markedly Statistical difference when compared to age range of 0 to 8 years (p < 0.05). Among congenital cardiopathies, the most frequent were: interventricular septal defect (26.0%) and tetralogy of Fallot (21.7%). Blood cultures, surgical material or emboli cultures were positive in 35 (70.0%) assessed patients. Streptococcus viridans (45.7%) and Staphylococcus aureus (42.8%) were the etiologic agents most often isolated. It was found that endocarditis by Staphylococcus aureus had mortality rate of 53.3% [(clinical (66.6%) and surgical (44.4%)], (p < 0.05) when compared to those by Streptococcus viridans; with total mortality of 6.2% (no clinical death and 16.6% in the surgical group). Total in-hospital mortality (clinical and surgical) was 26.0% (13 deaths). CONCLUSION: IE in infants and adolescents in this studied population presented Streptococcus viridans responsible for 46.7% of patients with endocarditis and the Staphylococcus aureus for 42.8% were the etiologic agents most often found. Total, clinical and surgical mortality was greater in patients with endocarditis by Staphylococcus aureus when compared with those by Streptococcus viridans. Among the congenital cardiopathies, whether operated on or not, ventricular septal defect and of Fallot's tetralogy were the most involved ones; rheumatic cardiopathy Still remains a significant predisposing factor to infective IE in our country.

[Radiologic signal of dehiscence of Starr-Edwards aortic prosthesis]. / Sinal radiológico de deiscência de prótese aórtica de Starr-Edwards.

A male 54 years-old patient with infective endocarditis through Staphylococcus aureus with prosthesis of Starr-Edwards aortic with clinical and echocardiographic signs compatible with dysfunction classified as severe. The x-ray images presented double silhouette of the prosthesis, thus suggesting its partial dehiscence. This case report points out that the detailed analysis of the X-ray may supply relevant data for the diagnosis of one of this complication thus influencing on management and prognosis.

[Myocardial infarction in infective endocarditis]. / Infarto do miocárdio na endocardite infecciosa.

Two patients with chronic valvular heart disease and myocardial infarction were assisted at our hospital. Both of them were febrile and only one had petechiae associated with signs of valvular involvement led to suspicion of infective endocarditis. Although blood cultures were negative, echocardiographic, surgical and anatomopathologic findings were compatible with infective endocarditis. They required cardiac surgery during the acute phase of the infection because they presented progressive hemodynamic deterioration and no satisfactory response to antimicrobial regimen too. One patient died at late follow-up (two weeks after the hospital discharge) and the other survived, but with signs of cardiac failure (class II of NYHA) one year after the procedure.