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Objectives: To compare the cost-effectiveness ratios of sirolimus-eluting stents (SES) with bare-metal stents (BMS) under two perspectives: the "supplementary medical system" (health plans and private patients) and the public health (SUS) system., Methods: A decision-analytic model using three different therapeutic strategies for coronary lesions: percutaneous coronary intervention (PCI) with BMS; with SES; or with BMS followed by SES to treat symptomatic restenosis. Study endpoints were one-year event-free survival and life expectancy. Decision trees were constructed using the results of published registries and clinical trials., Results: One-year restenosis-free survival was 92.7% with SES and 78.8% with BMS. Estimated life expectancy was very similar for all the strategies, ranging from 18.5 to 19 years. Under a nonpublic perspective, the cost difference in the first year between BMS and SES was R$3,816, with an incremental cost-effectiveness ratio of R$27,403 per event avoided in one year. Under the SUS perspective, the cost per event avoided in one year was R$47,529. In the sensitivity analysis, probability of restenosis, risk reduction expected with SES, the price of the stent and cost of treating restenosis were all important predictors. In the Monte Carlo simulation, data per years of life saved showed very high cost-effectiveness ratios., Conclusion: In the Brazilian model, the cost-effectiveness ratios for SES were elevated. The use of SES was more favorable for patients with high risk of restenosis, as it is associated with elevated costs in restenosis management of and under a nonpublic perspective.

Background: Coronary artery disease is the most prevalent cardiovascular disease. In the United States, 7% of adults over 20 years of age are estimated to have coronary artery disease. In Brazil, a prevalence of 5 to 8% has been estimated in adults over 40 years of age, with an increased number of hospitalizations associated with both stable and acute clinical manifestations; and health care costs have quadrupled in the last decade. To estimate the direct costs of managing ischemic heart disease patient care in a teaching hospital in Brazil from the perspective of the service payer, the Brazilian Unified Health System.Methods: This study was a retrospective cohort study for the identification and valuation of resources used at both the outpatient and in-hospital levels in a sample of 330 patients selected from the hospital's ischemic heart disease clinic. Data were collected from computerized hospital records and patients' hospital bills from January 2000 to October 2015. A bivariate analysis and binary logistic regression were performed with p < 0.05 considered statistically significant.Results: The study population consisted of 330 patients with a mean age 61 ± 10 years and a follow-up period of 107 ± 2.6 months; of the patients, 55% were male, 89% had hypertension, 48% had diabetes, and 65% had acute myocardial infarction. The mean annual cost of outpatient management was US $1,521 per patient. The mean cost per hospitalization was US $1,976, and the expenses were higher in the first and last years of follow-up. Unstable angina, revascularization procedures, diabetes, hypertension and obesity were predictors of higher hospitalization costs (p <0.05).Conclusion: The cost estimates in this study indicate a high proportion of drug treatment costs in the treatment of ischemic heart disease. Treatment costs are higher in the first year and at the end of treatment, and some clinical factors are associated with greater hospital care costs. These results may serve as a basis for the evaluation of existing public policies and inputs for cost-effectiveness studies in coronary artery disease.Trial Registration: CEP HCPA 11-0460 . Ethics Committee of Hospital de Clínicas de Porto Alegre. [ABSTRACT FROM AUTHOR]

Background: Many Brazilian patients with complex diseases who are treated in tertiary referral clinics have been stable for long periods. The main needs of these patients involve monitoring of risk factors and review of drug prescriptions, which could be satisfactorily done in primary care facilities. The goal of this protocol is to evaluate the safety and effectiveness of telemedicine services to support the transition of patients with stable chronic coronary artery disease from the tertiary to the primary level of care.Methods/design: We designed a randomized non-inferiority protocol that will include 280 patients with stable coronary artery disease (for at least 12 months). Patients will be selected from the Ischemic Heart Disease Clinic in a tertiary care hospital in southern Brazil. Enrolled participants will be randomized into one of two groups: 12 months of follow-up at the same clinic; or 12 months of follow-up at a primary care facility with clinical support from a telemedicine platform including a toll-free line for physicians (intervention group). In the intervention group, decisions to refer patients to tertiary care during follow-up will be made jointly by primary physicians and medical teleconsultants. The groups will be compared in terms of the primary outcome-maintenance of baseline functional class 1 or 2 after 12 months. Secondary outcomes include control of risk factors and instability of the disease.Discussion: We intend to determine the effectiveness of using telemedicine to qualify the transition of patients with chronic coronary disease from the tertiary to the primary level of care. This should facilitate the access of patients to the healthcare system, since care will be provided closer to their homes, and provide more opportunities for treatment of severe cases at tertiary care hospitals that are often overcrowded.Trial Registration: ClinicalTrials.gov # NCT02489565 - trial registration date May 13, 2015. [ABSTRACT FROM AUTHOR]

Background: Scarce information exists regarding the preventive effect of periodontal treatment in the recurrence of cardiovascular events. Prevention may be achieved by targeting risk factors for recurrent coronary artery disease (CAD) in patients with previous history of cardiovascular events. The aim of this trial is to compare the effect of two periodontal treatment approaches on levels of C-reactive protein, lipids, flow-mediated dilation and serum concentrations of proinflammatory and endothelial markers in stable CAD patients with periodontitis over a period of 12 months. Methods/design: This is a randomized, parallel design, examiner blinded, controlled clinical trial. Individuals from both genders, 35 years of age and older, with concomitant diagnosis of CAD and periodontitis will be included. CAD will be defined as the occurrence of at least one of the following events 6 months prior to entering the trial: documented history of myocardial infarction; surgical or percutaneous myocardial revascularization and lesion >50% in at least one coronary artery assessed by angiography; presence of angina and positive noninvasive testing of ischemia. Diagnosis of periodontitis will be defined using the CDC-AAP case definition (≥2 interproximal sites with clinical attachment loss ≥6 mm and ≥1 interproximal site with probing depth ≥5 mm). Individuals will have to present at least ten teeth present to be included. One hundred individuals will be allocated to test (intensive periodontal treatment comprised by scaling and root planing) or control (community periodontal treatment consisting of one session of supragingival plaque removal only) treatment groups. Full-mouth six sites per tooth periodontal examinations and subgingival biofilm samples will be conducted at baseline, 3, 6 and 12 months after treatment. The primary outcome of this study will be C-reactive protein changes over time. Secondary outcomes include levels of total cholesterol, LDL-C, HDL-C, triglycerides, IL-1β, IL-6, TNFα, fibrinogen, ICAM-1, VCAM-1 and E-selectin. These outcomes will be assessed at all time points over 12 months. Flow-mediated dilation will be assessed at baseline, 1, 3 and 6 months after periodontal therapy. Discussion: This trial will provide new evidence regarding the effect of periodontal treatment on risk markers for recurrence of cardiovascular events in stable coronary artery disease patients. [ABSTRACT FROM AUTHOR]

Background: Depressive symptoms are associated with impaired quality of life (QOL). However, there are scarce data comparing the magnitude of depression on QOL among persons with different chronic diseases in developing countries. This study aimed to evaluate the impact of depression on QOL in patients with ischemic heart disease (IHD) and end-stage renal disease (ESRD) in hemodialysis. Methods: Cross-sectional survey conducted in 173 patients: 103 with IHD and 70 in hemodialysis. Depression was diagnosed by the Mini International Neuropsychiatric Interview-5.0 and depressive symptoms measured by Beck Depression Inventory. QOL was assessed through the Short-Form-36 (SF-36) and World Health Organization Quality of Life Instrument-brief (WHOQOL-brief). Multivariate analyses were performed to assess the association between variables and QOL. Results: Depression prevalence was 14.3% among IHD patients and 9.9% in the hemodialysis group, and depressive symptoms were present in 39 and 36%, respectively. Regardless of the chronic condition, depressed patients presented lower QOL scores than non-depressed ones in all domains, and the most affected were role emotional, mental health and social functioning of SF-36, and psychological domain of WHOQOL-brief. In linear regression analysis, depressive symptoms were predictive for lower QOL in all domains, with the highest standardized beta coefficients (ranging from −0.26 to −0.64). Conclusion: Depression is an independent factor associated with worse QOL in IHD and ESRD patients. Among the priorities aiming at improving QOL must be evaluation and management of depressive symptoms. [ABSTRACT FROM AUTHOR]