Effect of a multifaceted quality improvement intervention on the prescription of evidence based treatment in patients at high cardiovascular risk in Brazil The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial

RESULTS Of the 1619 included patients,1029 (63.6%) weremale,1327(82.0%) had coronary artery disease (843[52.1%] with prioracutemyo cardial infarction),355(21.9%)had priorischemicstroke ortransientischemicattack,and197 (12.2%) had peripheral vascular disease,andthemean( SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary careunits,and 26 (65%) were teaching institutions.Amonge ligible patients,thosein intervention clusters were more like ly to receive aprescription of evidence-based therapies thant hose in control clusters (73.5%[515of701] vs58.7% [493of840];oddsratio,2.30;95%CI,1.14-4.65). There were no differences between the intervention and control group swithregard storisk factor control(ie,hyperlipidemia,hypertension,ordiabetes).Ratesofeducationforsmokingcessationwere higher among current smokers in the intervention group thanin the control group (51.9%[364of701] vs18.2%[153of840];oddsratio,11.24;95%CI,2.20-57.43).Therateofcardiovascularmortality,acute myocardial infarction,andstrokewas2.6%for patients from intervention cluster sand 3.4%forthose in the control group (hazardratio, 0.76;95%CI,0.43-1.34). (AU)

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

Eff ect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial / Eff ect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial

Background Rosiglitazone is a thiazolidinedione that reduces insulin resistance and might preserve insulin secretion.

The aim of this study was to assess prospectively the drug’s ability to prevent type 2 diabetes in individuals at high risk

of developing the condition.

Methods 5269 adults aged 30 years or more with impaired fasting glucose or impaired glucose tolerance, or both, and

no previous cardiovascular disease were recruited from 191 sites in 21 countries and randomly assigned to receive

rosiglitazone (8 mg daily; n=2365) or placebo (2634) and followed for a median of 3 years. The primary outcome was

a composite of incident diabetes or death. Analyses were done by intention to treat. This trial is registered at

Findings At the end of study, 59 individuals had dropped out from the rosiglitazone group and 46 from the placebo

group. 306 (11·6%) individuals given rosiglitazone and 686 (26·0%) given placebo developed the composite primary

outcome (hazard ratio 0·40, 95% CI 0·35–0·46; p<0·0001); 1330 (50·5%) individuals in the rosiglitazone group and

798 (30·3%) in the placebo group became normoglycaemic (1·71, 1·57–1·87; p<0·0001). Cardiovascular event rates

were much the same in both groups, although 14 (0·5%) participants in the rosiglitazone group and two (0·1%) in the

Interpretation Rosiglitazone at 8 mg daily for 3 years substantially reduces incident type 2 diabetes and increases the

likelihood of regression to normoglycaemia in adults with impaired fasting glucose or impaired glucose tolerance, or

Rationale and design of ACTIVE: the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events.

BACKGROUND: Atrial fibrillation (AF) is the most frequently occurring cardiac arrhythmia with often serious clinical consequences. Many patients have contraindications to anticoagulation, and it is often underused in clinical practice. The addition of clopidogrel to aspirin (ASA) has been shown to reduce vascular events in a number of high-risk populations. Irbesartan is an angiotensin receptor-blocking agent that reduces blood pressure and has other vascular protective effects. METHODS AND RESULTS: ACTIVE W is a noninferiority trial of clopidogrel plus ASA versus oral anticoagulation in patients with AF and at least 1 risk factor for stroke. ACTIVE A is a double-blind, placebo-controlled trial of clopidogrel in patients with AF and with at least 1 risk factor for stroke who receive ASA because they have a contraindication for oral anticoagulation or because they are unwilling to take an oral anticoagulant. ACTIVE I is a partial factorial, double-blind, placebo-controlled trial of irbesartan in patients participating in ACTIVE A or ACTIVE W. The primary outcomes of these studies are composites of vascular events. A total of 14000 patients will be enrolled in these trials. CONCLUSIONS: ACTIVE is the largest trial yet conducted in AF. Its results will lead to a new understanding of the role of combined antiplatelet therapy and the role of blood pressure lowering with an angiotensin II receptor blocker in patients with AF.

Design and rationale of the MICHELANGELO Organization to Assess Strategies in Acute Ischemic Syndromes (OASIS)–5 trial program evaluating fondaparinux, a synthetic factor Xa inhibitor, in patients with non–ST-segment elevation acute coronary syndromes

Background Factor Xa plays a central role in the generation of thrombin, making it a novel target for treatment

of arterial thrombosis. Fondaparinux, a synthetic pentasaccharide, is a factor Xa inhibitor, which has been shown to be

superior to enoxaparin for the prevention of venous thrombosis. We designed a large, phase III, randomized trial to

evaluate the efficacy and safety of fondaparinux compared with enoxaparin in acute coronary syndromes.

Study Design The OASIS–5 trial is a randomized, double-blind trial of fondaparinux versus enoxaparin in

20000 patients with unstable angina or non–ST-segment elevation myocardial infarction. The primary objective is to determine

whether fondaparinux is noninferior to enoxaparin in preventing the composite of death, new myocardial infarction, and

refractory ischemia at 9 days (primary outcome) and at 30 days (secondary outcome) after randomization. There will be

additional follow-up of all patients for 3 to 6 months after randomization. If noninferiority is established at 9 days, superiority will

be tested. The primary safety outcome is to evaluate the rates of major bleeds in the 2 groups with the balance of benefit and risk

assessed by comparing the impact on the composite of the primary and safety outcomes. Secondary outcomes are each

component of the composite primary outcome separately at days 9, 30, and up to 6 months. The TIMACS, a major substudy

using a partial 2 2 factorial design evaluating whether early angiography and intervention (within 24 hours) are superior to a

more delayed approach (after 36 hours) in reducing major ischemic events at 6 months after randomization.

Conclusions The MICHELANGELO OASIS 5 program will provide a comprehensive and reliable evaluation of

fondaparinux in a broad spectrum of patients with ACS.

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.