Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.

BACKGROUND: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. METHODS: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. RESULTS: A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. CONCLUSIONS: In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).

A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial.

The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. SUMMARY: RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.

Rationale and design for a cluster randomized quality-improvement trial to increase the uptake of evidence-based therapies for patients at high cardiovascular risk: The BRIDGE-Cardiovascular Prevention trial.

BACKGROUND: Translating evidence into clinical practice in the management of high cardiovascular risk patients is challenging. Few quality improvement interventions have rigorously evaluated their impact on both patient care and clinical outcomes. OBJECTIVES: The main objectives are to evaluate the impact of a multifaceted educational intervention on adherence to local guidelines for the prescription of statins, antiplatelets and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers for high cardiovascular risk patients, as well as on the incidence of major cardiovascular events. DESIGN: We designed a pragmatic two arm cluster randomized trial involving 40 clusters. Clusters are randomized to receive a multifaceted quality improvement intervention or to routine practice (control). The multifaceted intervention includes: reminders, care algorithms, training of a case manager, audit and feedback reports, and distribution of educational materials to health care providers. The primary endpoint is the adherence to combined evidence-based therapies (statins, antiplatelet therapy and angiotensin converting enzyme inhibitors or angiotensin receptor blockers) at 12 months after the intervention period in patients without contra-indications for these medications. All analyses follow the intention-to-treat principle and take the cluster design into account using linear mixed logistic regression modeling. SUMMARY: If proven effective, this multifaceted intervention would have wide utility as a means of promoting optimal usage of evidence-based interventions for the management of high cardiovascular risk patients.

Morphology and phenotype characteristics of atherosclerotic plaque in patients with acute coronary syndrome: contemporary optical coherence tomography findings.

BACKGROUND: Contemporary optical coherence tomography (OCT) findings in patients with acute coronary syndromes (ACS) are still subject of controversy. We sought to use OCT to evaluate plaque morphology and phenotype classification in patients with ACS. METHODS: Using optical coherence tomography, culprit lesions were morphologically classified as plaque rupture, plaque erosion, calcified nodule, thin-cap fibroatheroma, thick-cap fibroatheroma (TCFA) or fibrotic, fibrocalcific or fibrolipidic plaque. Quantitative and qualitative analyses also included cholesterol crystals, neovascularization, spotty calcification and thrombus. RESULTS: Of the 110 lesions imaged from June 2012 to April 2016, 54 (49%) were in patients with unstable angina (UA), 31 (28%) were in non-ST-elevation myocardial infarction (STEMI) patients and 25 (23%) were in STEMI patients. Compared with STEMI patients, patients with UA/non-STEMI were older and had more hypertension, hypercholesterolemia, known coronary artery disease, prior myocardial infarction and higher use of antiplatelet therapy. More patients with STEMI had lipidic arc >90% (36.6 versus 70.8%, P = 0.003), red and mixed thrombus (12.9 versus 28.0% and 7.1 versus 44.0%, respectively, all P < 0.001), plaque rupture (29.4 versus 76.0%, P < 0.001) and TCFA (57.1 versus 84.0%; P = 0.01). Predictors of plaque rupture were STEMI at presentation (odds ratio: 9.35, 95% confidence interval: 1.66-52.61, P = 0.01) and diabetes mellitus (odds ratio: 6.16, 95% confidence interval: 1.33-28.58, P = 0.02). CONCLUSIONS: In this single-center study, the culprit lesion of patients with STEMI had more lipid, red and mixed thrombus, plaque rupture and TCFA versus patients with UA/non-STEMI. Clinical presentation may be driven by distinct pathophysiologic mechanisms in patients with ACS.

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.

Importance: Studies have found that patients at high cardiovascular risk often fail to receive evidence-based therapies in community practice. Objective: To evaluate whether a multifaceted quality improvement intervention can improve the prescription of evidence-based therapies. Design, Setting, and Participants: In this 2-arm cluster randomized clinical trial, patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied. Patients were recruited from August 2016 to August 2017, with follow-up to August 2018. Data were analyzed in September 2018. Interventions: Case management, audit and feedback reports, and distribution of educational materials (to health care professionals and patients) vs routine practice. Main Outcomes and Measures: The primary end point was prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) using the all-or-none approach at 12 months after the intervention period in patients without contraindications. Results: Of the 1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary care units, and 26 (65%) were teaching institutions. Among eligible patients, those in intervention clusters were more likely to receive a prescription of evidence-based therapies than those in control clusters (73.5% [515 of 701] vs 58.7% [493 of 840]; odds ratio, 2.30; 95% CI, 1.14-4.65). There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes). Rates of education for smoking cessation were higher among current smokers in the intervention group than in the control group (51.9% [364 of 701] vs 18.2% [153 of 840]; odds ratio, 11.24; 95% CI, 2.20-57.43). The rate of cardiovascular mortality, acute myocardial infarction, and stroke was 2.6% for patients from intervention clusters and 3.4% for those in the control group (hazard ratio, 0.76; 95% CI, 0.43-1.34). Conclusions and Relevance: Among Brazilian patients at high cardiovascular risk, a quality improvement intervention resulted in improved prescription of evidence-based therapies. Trial Registration: ClinicalTrials.gov identifier: NCT02851732.

Avaliação da massa ventricular esquerda em hipertensos com tolerância à glicose diminuída / Evaluation of left ventricular mass in hypertensive patients with decreased glucose tolerance

Fundamentos: cresce em importância a relação entre níveis glicêmicos aumentados, porém não diabéticos (tolerância à glicose diminuída - TGD), fator de risco cardiovascular e hipertrofia ventricular esquerda (HVE). Objetivo: avaliar a massa do ventrículo esquerdo (MVE) em pacientes hipertensos sob tratamento ambulatorial e com TGD. Materiais e métodos: foram avaliados 358 pacientes hipertensos (com média de idade 59 ± 11 anos), divididos em três grupos: grupo I (hipertensos); grupo II (hipertensos com TGD) e grupo III (hipertensos com diabetes tipo 2). Em todos os pacientes foi realizado o ecocardiograma e utilizada a fórmula de Devereux para o cálculo da massa do ventrículo esquerdo (MVE). Para o índice de MVE (IMVE) foram considerados valores normais de até 89 e 103 g/m² para mulheres e homens, respectivamente. Utilizou-se o teste estatístico ANOVA complementado pelo teste de Tukey e Bonferroni para detectar diferenças entre os grupos. Resultados: a média do IMVE foi de 110,2 ± 33,0; 117,6 ± 30,1 e 128,0 ± 46,8 g/m² nos grupos I, II e III, respectivamente, sendo que 65,1% (grupo I), 74,6% (grupo II) e 80,5% (grupo III) dos pacientes apresentaram aumento do IMVE. Não houve diferença estatística no aumento de IMVE entre os grupos I e II, mas foi significantemente maior no grupo III, quando comparado com o grupo I. Conclusões: o grupo dos pacientes hipertensos com TGD (grupo II) não apresentou aumento de MVE estatisticamente significante em relação aos não intolerantes (grupo I) e o grupo de pacientes hipertensos e diabéticos apresentou aumento significante da MVE em relação ao grupo de hipertensos (grupo I).

Background: It is growing in importance the correlation between elevated glycemic levels (impaired glucose tolerance) but no overt diabetes and the risk factor of cardiovascular disease and increased cardiac mass. Objective: We sought to determine the left ventricular mass (LVM) in hypertensive patients under treatment and with impaired glucose tolerance (IGT). Materials and methods: 358 patients were evaluated (mean age 59 ± 11 years) separated in three groups: group I (hypertension); group II (hypertension and IGT) and group III (hypertension and diabetes mellitus 2). Echocardiograms were performed in all patients and the left ventricular mass index (LVMI) was calculated using the Devereux's criteria and values greater than 110 and 134 g/m² for women and man, respectively, were considered for left ventricular hypertrophy. The statistic methods ANOVA together with Tukey and Bonferroni tests were executed to detect differences among groups. Results: 110,2 ± 33,0; 117,6 ± 31,0 and 128,0 ± 46,8 g/m² were the mean of LVMI for groups I, II and III, respectively. The increasing of LVM was 65,1% (group I), 74,6% (group II) and 80,5% (group III). There was not statistic difference between groups I and II in relation to increasing of LVMI, but it was significantly greater in group III. Conclusions: The increasing of LVMI was not observed in the impaired glucose tolerance hypertensive patients when compared with normoglycemic hypertensive patients and the increasing of LVMI was significant in diabetic hypertensive patients.

Programa de Avaliaçäo Nacional do Conhecimento sobre Prevençäo da Aterosclerose (PANDORA): um questionário entre cardiologistas brasileiros sobre reduçäo do colesterol / PANDORA: survey of Brazilian cardiologists about cholesterol reduction

OBJECTIVE: To report about a group of physicians' understanding of the recommendations of the II Brazilian Guidelines Conference on Dyslipidemias, and about the state of the art of primary and secondary prevention of atherosclerosis. METHODS: Through the use of a questionnaire on dyslipidemia, atherosclerosis prevention, and recommendations for lipid targets established by the II Brazilian Guidelines Conference on Dyslipidemias, 746 physicians, 98 percent cardiologists, were evaluated. RESULTS:Eighty-seven percent of the respondents stated that the treatment of dyslipidemia changes the natural history of coronary disease. Although most of the participants followed the total cholesterol recommendations (<200mg/dL for atherosclerosis prevention), only 55.8 percent would adopt the target of LDL-C <100 mg/dL for secondary prevention. Between 30.5 and 36.7 percent answered, in different questions, that the recommended level for HDL-C should be <35mg/dL. Only 32.7 percent would treat their patients indefinitely with lipid- lowering drugs. If the drug treatment did not reach the proposed target, only 35.5 percent would increase the dosage, and 29.4 percent would change the medication. Participants did not know the targets proposed for diabetics. CONCLUSION: Although the participating physicians valued the role played by lipids in the prevention of atherosclerosis, serious deficiencies exist in their knowledge of the recommendations given during the II Brazilian Guidelines Conference on Dyslipidemias