Two-Year Clinical Outcome after Carvedilol-Loaded Stent Implantation in Patients with Coronary Artery Disease

BACKGROUND/AIMS: Carvedilol is an antioxidant that inhibits smooth muscle cell proliferation and migration. The aim of this study was to investigate the beneficial effects of carvedilol-loaded stents on 2-year clinical outcomes after stent implantation in patients with coronary artery disease. METHODS: We performed a prospective trial with male subjects to compare the safety and effects of carvedilol-loaded BiodivYsio(R) stents implanted into 20 patients with those of bare-metal BiodivYsio(R) stents implanted into 21 patients for de novo coronary lesions. The primary end point was the degree of neointimal hyperplasia, which was measured by intravascular ultrasound (IVUS) 6 months after the procedure; the secondary end point was major adverse cardiac events (MACE) at 2 years after implantation. All carvedilol and control stents were deployed successfully. RESULTS: A 2-year follow-up was completed for 19 patients (95%) in the carvedilol stent group and 20 patients (95%) in the control stent group. IVUS showed a trend toward a larger luminal area (6.86 +/- 2.59 vs. 5.47 +/- 1.52 mm2, p = 0.267), smaller neointimal area (1.34 +/- 0.70 vs. 2.40 +/- 1.73 mm2, p = 0.18), and reduced net decrease in luminal area (-0.78 +/- 0.97 vs. -1.89 +/- 1.78 mm2, p = 0.106) in the carvedilol stent group compared with the control stent group, respectively. There were no significant differences in the incidence of MACE (10.5 vs. 30.0%, respectively, p = 0.132) between the groups at 2 years after stent implantation. Stent thrombosis did not occur in either group after 2 years. CONCLUSIONS: The carvedilol-loaded stents tended to inhibit neointimal hyperplasia without the occurrence of cardiac death, myocardial infarction, or stent thrombosis at 2-year follow-up.

The relationship between heart rate reserve and oxygen uptake reserve in heart failure patients on optimized and non-optimized beta-blocker therapy

BACKGROUND: The relationship between the percentage of oxygen consumption reserve and percentage of heart rate reserve in heart failure patients either on non-optimized or off beta-blocker therapy is known to be unreliable. The aim of this study was to evaluate the relationship between the percentage of oxygen consumption reserve and percentage of heart rate reserve in heart failure patients receiving optimized and non-optimized beta-blocker treatment during a treadmill cardiopulmonary exercise test. METHODS: A total of 27 sedentary heart failure patients (86 percent male, 50±12 years) on optimized beta-blocker therapy with a left ventricle ejection fraction of 33±8 percent and 35 sedentary non-optimized heart failure patients (75 percent male, 47±10 years) with a left ventricle ejection fraction of 30±10 percent underwent the treadmill cardiopulmonary exercise test (Naughton protocol). Resting and peak effort values of both the percentage of oxygen consumption reserve and percentage of heart rate reserve were, by definition, 0 and 100, respectively. RESULTS: The heart rate slope for the non-optimized group was derived from the points 0.949±0.088 (0 intercept) and 1.055±0.128 (1 intercept), p<0.0001. The heart rate slope for the optimized group was derived from the points 1.026±0.108 (0 intercept) and 1.012±0.108 (1 intercept), p=0.47. Regression linear plots for the heart rate slope for each patient in the non-optimized and optimized groups revealed a slope of 0.986 (almost perfect) for the optimized group, but the regression analysis for the non-optimized group was 0.030 (far from perfect, which occurs at 1). CONCLUSION: The relationship between the percentage of oxygen consumption reserve and percentage of heart rate reserve in patients on optimized beta-blocker therapy was reliable, but this relationship was unreliable in non-optimized heart failure patients.

Perfil do tratamento da insuficiência cardíaca na era dos betabloqueadores / Heart failure treatment profile at the beta blockers era

OBJETIVOS: A inibição dos sistemas renina-angiotensina-aldosterona (SRAA) e sistema nervoso autônomo simpático aumentou a perspectiva de sobrevida desses pacientes, além de permitir substancial melhora na qualidade de vida. O objetivo deste trabalho foi avaliar a realidade do tratamento aplicado e seu impacto sobre a doença em pacientes acompanhados em um ambulatório especializado em insuficiência cardíaca(IC). MÉTODOS: Foram estudados 96 pacientes acompanhados no ambulatório de Insuficiência Cardíaca e Transplante do Instituto do Coração, do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP). Os dados foram coletados durante a consulta ambulatorial a partir de prontuário médico e exame clínico. A escolha dos pacientes foi aleatória. RESULTADOS: A maior parte dos pacientes encontrava-se em classe funcional II (42,3 por cento) e em estágio C de evolução (94,9 por cento). A prescrição médica para os pacientes foi bastante próxima do preconizado pelas diretrizes. Aproximadamente 95 por cento recebem inibidores do SRAA (inibidor de ECA - enalapril e captopril - ou antagonista dos receptores de angiotensina-losartan), enquanto 85 por cento dos pacientes recebem, além desses, agentes betabloqueadores (carvedilol). A dose média prescrita também se aproxima das utilizadas nos grandes estudos, e atinge mais de 60 por cento da dose máxima de cada medicação. Os dados hemodinâmicos encontrados mostram pacientes estáveis, apesar da intensidade da disfunção e do remodelamento ventricular destes. CONCLUSÃO: Pacientes portadores de IC acompanhados por equipe médica especializada têm prescrição médica mais próxima do preconizado. Esses pacientes, embora com características marcadas de gravidade da doença, conseguem estabilidade hemodinâmica e clínica com a otimização terapêutica adequada.

OBJECTIVES: The inhibition of the rennin-angiotensin-aldosterone system (RAAS) and sympathetic autonomous nervous system has increased the perspective of survival in these patients, as well as allowing the improvement of the quality of life. The aim of this study was to evaluate the reality of the treatment employed and its impact on the disease in patients followed at a specialized heart failure (HF) outpatient clinic. METHODS: A sample of 96 patients followed at the HF and Transplant Outpatient Clinic of Heart Institute of the University of São Paulo School of Medicine (InCor -HCFMUSP) were evaluated. The data were collected during the ambulatory consultation from the medical files and through physical examination. Patients were randomly selected for the study. RESULTS: Most of the patients were Functional Class II (42.3 percent) and evolution stage C (94.9 percent). The medical prescription given to the patients was quite similar to the one recommended by the directives. Approximately 95 percent of them received RAAS inhibitors (ACE inhibitor - enalapril and captopril - or angiotensin receptor antagonist - losartan), whereas 85 percent of the patients additionally received beta blockers (carvedilol). The mean dose prescribed was also similar to the one used in large studies and reached more than 60 percent of the maximum dose for each medication. The hemodynamic data show that patients were stable, despite the intensity of the dysfunction and ventricular remodeling observed in these patients. CONCLUSION: Patients with HF followed by a specialized medical team receive a medical prescription that is closer to the recommended one. These patients, despite the marked characteristics of disease severity, achieve hemodynamic and clinical stability with an adequate therapeutic optimization.

Efeito do carvedilol na insuficiência cardíaca por cardiomiopatia dilatada: resultado de estudo duplo-cego, randômico, com grupo placebo-controle (estudo CARIBE) / Effects of carvedilol in heart failure due to dilated cardiomyopathy: results of a double-blind randomized placebo-controlled study (CARIBE study)

OBJECTIVE: To assess the effects of carvedilol in patients with idiopathic dilated cardiomyopathy. METHODS: In a double-blind randomized placebo-controlled study, 30 patients (7 women) with functional class II and III heart failure were assessed. Their ages ranged from 28 to 66 years (mean of 43ñ9 years), and their left ventricular ejection fraction varied from 8 per cnet to 35 per cent. Carvedilol was added to the usual therapy of 20 patients; placebo was added to the usual therapy of 10 patients. The initial dose of carvedilol was 12.5 mg, which was increased weekly until it reached 75 mg/day, according to the patient's tolerance. Clinical assessment, electrocardiogram, echocardiogram, and radionuclide ventriculography were performed in the pretreatment phase, being repeated after 2 and 6 months of medication use. RESULTS: A reduction in heart rate (p=0.016) as well as an increase in left ventricular shortening fraction (p=0.02) and in left ventricular ejection fraction (p=0.017) occurred in the group using carvedilol as compared with that using placebo. CONCLUSION: Carvedilol added to the usual therapy for heart failure resulted in better heart function.

Efecto del carvedilol sobre la fracción de eyección y capacidad de ejercicio en pacientes con insuficiencia cardíaca / Effect of carvedilol on left ventricular ejection fraction and exercise performance in patients with chronic heart failure

Se evaluó el uso del carvedilol en pacientes con insuficiencia cardíaca mediante un ensayo clínico a doble ciego, valorándose la fracción de eyección y la capacidad de ejercicio. Se incluyó a 33 pacientes, a 14 se les administró placebo y a 19 carvedilol. La fracción de eyección basal fue 26,2 por ciento y 22 por ciento (p< 0,11), el tiempo de ejercicio fue 9,5 minutos y 9 minutos (p< 0,73), para los grupos tratados con carvedilol y con placebo respectivamente. La fracción de eyección, al final del estudio, fue 34,5 por ciento y 24,5 por ciento para los pacientes tratados con carvedilol y placebo en cada caso (p< 0,03). El tiempo de ejrcicio aumentó significativamente, 13,8 minutos y 10,6 minutos (p< 0,02)

Valoración clínica del efecto analgésico de carprofeno en la coxartrosis y gonartrosis / Clinical evaluation of analgesic effect of carprofen in coxartrosis and gonartrosis

Mediante estudio clínico doble ciego se realizó la valoración del efecto sintomático de carprofeno y sulindac (ambos administrados por vía oral) en dos grupos de 15 pacientes cada uno con osteoartrosis de rodilla, cadera o ambas. Se tomaron como parámetros el dolor, medio mediante diversos procedimientos por el médico y el paciente; la rigidez articular subjetiva al iniciar la marcha postreposo; la valoración del estado reumático; y la aceptación del medicamento por el paciente. Se demostró superioridad clínica del efecto sintomático de carprofeno por la respuesta observada en los diferentes parámetros; la tolerancia al medicamento fue semejante en ambos compuestos

Valoración del efecto sintomático de carprofeno en osteartrosis / Evaluation of the symptomatic effect of carprofen in osteoarthrtis

Mediante estudio doble ciego, se comparó el efecto sintomático de carprofeno y sulindac en pacientes con osteoartrosis de cadera, rodilla o ambas. Se analizan los resultados obtenidos para todos los síntomas relacionados con el proceso articular degenerativo: dolor en todas sus formas de manifestación y rigidez articular subjetiva; se hizo el registro con escalas de intensidad y escala visual analógica. Se consideraron también las opiniones globales del investigador y los pacientes así como la aparición de efectos indeseables. Se concluye que el efecto sintomático de carprofeno y sulindac es semejante aun cuando la analgesia total fue un suceso más común con el primero. La tolerancia fue muy superior en el grupo tratado con carprofeno registrándose efectos indeseables con una frecuencia tres veces mayor con sulindac que con carprofeno