Comparative cost-effectiveness of surgery, angioplasty, or medical therapy in patients with multivessel coronary artery disease: MASS II trial.

BACKGROUND: The costs for treating coronary artery disease (CAD) are high worldwide. We performed a prespecified analyses of cost-effectiveness of three therapeutic strategies for multivessel CAD. METHODS: From May 1995 to May 2000, a total of 611 patients were randomly assigned to coronary artery bypass graft (CABG), n = 203; percutaneous coronary intervention (PCI), n = 205; or medical treatment (MT), n = 203. This cost analysis study was based on the perspective of the Public Health Care System. Initial procedural and follow-up costs for medications, cardiology examinations, and hospitalizations for complications were calculated after randomization. Life-years and quality-adjusted life years (QALYs) were used as effectiveness measures. Incremental cost-effectiveness ratios (ICER) were obtained by using nonparametric bootstrapping methods with 5000 resamples. RESULTS: Initial procedural costs were lower for MT. However, the subsequent 5-year cumulative costs were lower for CABG. Compared with baseline, the three treatment options produced significant improvements in QALYs. After 5 years, PCI and CABG had better QALYs results compared with MT. The ICER results favored CABG and PCI, and favored PCI over CABG in 61% of the drawings. On the other hand, sensitivity analysis showed MT as the preferred therapy compared with CABG and PCI, in the analysis considering higher costs. CONCLUSIONS: At 5-year follow-up, the three treatment options yielded improvements in quality of life, with comparable and acceptable costs. However, despite higher initial costs, the comparison of cost-effectiveness after 5 years of follow-up among the three treatments showed both interventions (CABG and PCI) to be cost-effective strategies compared with MT.Trial registration ISRCTN, ISRCTN66068876, Registered 06/10/1994, http://www.controlled-trials.com/ISRCTN66068876.

Cost-effectiveness of on-pump and off-pump coronary artery bypass grafting for patients with coronary artery disease: Results from the MASS III trial.

BACKGROUND: Recent trials have reported similar clinical outcomes between on-pump and off-pump coronary artery bypass graft (CABG). However, long-term cost-effectiveness of these strategies is unknown. METHODS: A prespecified economic study was performed based on the MASS III trial. Costs were estimated for all patients based on observed healthcare resource usage over a 5-year follow-up. Health state utilities were evaluated with the SF-6D questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a Markov model. Probabilistic sensitivity analysis with the Monte-Carlo simulation and cost-effectiveness acceptability curve were used to address uncertainty. RESULTS: Quality of life improved significantly in both groups during follow-up compared with baseline. At 5 years, when comparing on-pump and off-pump CABG groups, no differences were found in cumulative life-years (4.851 and 4.766 years, P = .319) and QALY gained (4.150 and 4.105 QALYs, P = .332). Mean cost in US dollars per patient during the trial did not differ significantly between the on-pump and off-pump groups ($5890.29 and $5674.75, respectively, P = .409). Over a lifetime horizon, the incremental cost-effectiveness ratio of on-pump versus off-pump CABG was $12,576 per QALY gained, which is above the suggested cost-effectiveness threshold range (from $3210 to 10,122). In the sensitivity analysis, the probability that on-pump CABG is cost-effective compared to off-pump surgery for a willingness-to-pay threshold of $3212 per QALY gained was <1%. For the $10,122 per QALY threshold, the same probability was 35%. CONCLUSION: This decision-analytic model suggests that on-pump CABG is not cost-effective when compared to off-pump CABG from a public health system perspective.

Utility and quality-adjusted life-years in coronary artery disease: Five-year follow-up of the MASS II trial.

OBJECTIVES: This study evaluated the utility and quality-of-life year measurements for patients with coronary artery disease who underwent any of 3 therapeutic strategies with a 5-year follow-up. METHODS: Quality-of-life data were obtained from the Medicine, Angioplasty, or Surgery Study II trial. To obtain utilities, the 36-Item Short-Form questionnaire was converted to a 6-Dimensional Health State Classification System. RESULTS: Of the 611 initial patients, 579 completed the questionnaire. In all, 188 patients received the surgical treatment-194 the percutaneous, and the remaining 197 the medical. The median utility scores for the 5 years analyzed were 0.809 (95% confidence interval [CI] 0.794-0.842) for patients assigned to percutaneous coronary intervention, 0.755 (95% CI 0.723-0.774) for medical treatment, and 0.780 (95% CI 0.761-0.809) for coronary artery bypass graft surgery. The difference between percutaneous coronary intervention and medical treatment was statistically significant (P < .05, Dunn test). The median cumulative quality-of-life years across the 5 years were 3.802 (95% CI 3.668-3.936) for percutaneous, 3.540 (95% CI 3.399-3.681) for medical, and 3.764 (95% CI 3.638-3.890) for surgery. Additionally, the median quality-of-life years between percutaneous and medical treatment was 0.262 (95% CI 0.068-0.456), between surgery and medical treatment it was 0.224 (95% CI 0.036-0.413), and between surgery and percutaneous coronary intervention it was -0.038 (95% CI -0.221 to -0.146). CONCLUSION: Coronary artery bypass surgery and percutaneous coronary intervention were similar regarding cumulative quality-of-life years; however, they were both superior to that of medical treatment. The results presented are valuable data for further cost-utility studies.

Accuracy of Myocardial Biomarkers in the Diagnosis of Myocardial Infarction After Revascularization as Assessed by Cardiac Resonance: The Medicine, Angioplasty, Surgery Study V (MASS-V) Trial.

BACKGROUND: The lack of a correlation between myocardial necrosis biomarkers and electrocardiographic abnormalities after revascularization procedures has resulted in a change in the myocardial infarction (MI) definition. METHODS: Patients with stable multivessel disease who underwent percutaneous or surgical revascularization were included. Electrocardiograms and concentrations of high-sensitive cardiac troponin I (cTnI) and creatine kinase (CK)-MB were assessed before and after procedures. Cardiac magnetic resonance and late gadolinium enhancement were performed before and after procedures. MI was defined as more than five times the 99th percentile upper reference limit for cTnI and 10 times for CK-MB in percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), respectively, and new late gadolinium enhancement for cardiac magnetic resonance. RESULTS: Of the 202 patients studied, 69 (34.1%) underwent on-pump CABG, 67 (33.2%) off-pump CABG, and 66 (32.7%) PCI. The receiver operating characteristic curve showed the accuracy of cTnI for on-pump CABG, off-pump CABG, and PCI patients was 21.7%, 28.3%, and 52.4% and for CK-MB was 72.5%, 81.2%, and 90.5%, respectively. The specificity of cTnI was 3.6%, 9.4%, and 42.1% and of CK-MB was 73.2%, 86.8%, and 96.4%, respectively. Sensitivity of cTnI was 100%, 100%, and 100% and of CK-MB was 69.2%, 64.3%, and 44.4%, respectively. The best cutoff of cTnI for on-pump CABG, off-pump CABG, and PCI was 6.5 ng/mL, 4.5 ng/mL, and 4.5 ng/mL (162.5, 112.5, and 112.5 times the 99th percentile upper reference limit) and of CK-MB was 37.5 ng/mL, 22.5 ng/mL, and 11.5 ng/mL (8.5, 5.1, and 2.6 times the 99th percentile upper reference limit), respectively. CONCLUSIONS: Compared with cardiac magnetic resonance, CK-MB was more accurate than cTnI for diagnosing MI. These data suggest a higher troponin cutoff for the diagnosis of procedure-related MI.

Presença de microalbuminúria como fator de risco em pacientes diabéticos portadores de doença arterial coronária estável / Microalbuminuria as a risk factor in diabetic patients with stable coronary artery disease

A microalbuminúria é admitida como o principal marcadorpara o desenvolvimento de nefropatia diabética. Sua presençatambém é preditora independente de morbidade e mortalidadecardiovasculares. A relação da microalbuminúria com fatoresde risco clássicos para a doença multiarterial coronária (DAC)também tem sido mostrada em estudos epidemiológicos. Opresente estudo tem o objetivo de determinar a prevalênciade microalbuminúria em um grupo de pacientes diabéticosportadores de DAC e relacionar a sua presença com os fatoresclássicos de risco cardiovascular. Trata-se de um estudotransversal realizado com pacientes diabéticos portadoresde DAC, que realizam tratamento no Instituto do Coração(InCor-HCFMUSP). Foram avaliados os seguintes parâmetros:idade, presença ou ausência de HAS, tempo de diabetes,tabagismo, perfil lipídico, hemoglobina glicada e presença demicroalbuminúria/proteinúria, a partir da coleta urinária em24 horas. Os pacientes foram estratificados em três grupos,conforme o valor de albuminúria. Foram feitas análisesestatísticas comparando as diferentes variáveis entre os trêsgrupos. Nesta amostra de pacientes portadores de DM e DACmultiarterial estável, observou-se uma relação crescente entreos valores de albuminúria e o tempo de diabetes mellitus, níveisséricos de LDL-colesterol e triglicérides.

Microalbuminuria is accepted as a surrogate marker for thedevelopment of diabetic nephropathy. Its presence is alsoan independent predictor of cardiovascular morbidity andmortality. The relationship of microalbuminuria with classicrisk factors for coronary multivessel disease (CAD) has alsobeen shown in epidemiological studies. The present studyaims to determine the prevalence of microalbuminuria ina group of diabetic patients with CAD and correlate theirpresence with the classic cardiovascular risk factors. This isa cross-sectional study with diabetic patients with CAD whoperform treatment at the Heart Institute (Incor-HCFMUSP).We evaluated the following parameters: age, presence orabsence of hypertension, duration of diabetes, smoking, lipidprofile, glycated hemoglobin and microalbuminuria/proteinuriafrom urine collection in 24 hours. Patients were stratified into3 groups according to the value of albuminuria. Statisticalanalyzes were performed comparing the different variablesamong the three groups. In this sample of patients with diabetesand stable multivessel CAD there was a growing relationshipbetween the values of albuminuria and duration of diabetesmellitus, serum LDL-cholesterol and triglycerides.

Aplicação de questionários de qualidade de vida na doença arterial coronariana / The application of surveys of quality of life in coronary artery disease

O avanço dos métodos diagnósticos, o melhor entendimento da fisiopatologia dos eventos coronarianos, a eficiência das medidas de prevenção cardiovasculares e a utilização de fármacos têm permitido modificar a evolução e o prognóstico da DAC. Essas ferramentas contribuíram, de um lado, para um aumento da sobrevivência e, de outro, para o prolongamento das possíveis comorbidades desencadeadas pelas doenças crônicas. Assim, tais condições poderão interferir no estado emocional, físico, social e, principalmente, na qualidade de vida. Qualidade de vida é uma expressão com diferentes representações, sendo hoje uma importante medida de desfecho, muito mencionada nos últimos tempos, seja na linguagem cotidiana ou no contexto científico. O conceito não é novo, porém sua importância e uso tem sido necessário na prática dos cuidados e nas pesquisas em saúde, que desperta o interesse em investigar este aspecto em decorrência das mudanças demográficas caracterizadas, principalmente, pela longevidade e pelo crescimento econômico que impõem a adoção de novos paradigmas nas políticas públicas e nas práticas de saúde...

Quality of life after surgical myocardial revascularization, angioplasty or medical treatment.

BACKGROUND: Although the clinical benefits of coronary interventions seem to be confirmed, their effects on quality of life (QoL) are still scarcely studied. OBJECTIVE: To assess the QoL in multivessel coronary disease in patients randomly undergoing surgery, angioplasty or medical treatment. METHODS: The Short-Form Health Survey (SF-36) questionnaire was answered by 483 patients. Of these, 161 underwent surgical revascularization, 166 underwent angioplasty, and 153 were medically treated. RESULTS: At baseline, 86% of the patients referred angina, 34% referred infarction, and 32% were smokers. Medical Treatment: 12 patients (7.7%) had AMI, 24 (15.3%) underwent surgery, and 19 (12.1%) died. In addition, 5 (3.2%) had stroke, and 40 (25.6%) had angina. As regards the mental component, 64.1% and 30.8% had their condition improved and worsened, respectively. As regards the physical component, 70.5% and 27.6% had their condition improved and worsened, respectively. SURGERY: 13 patients (8.1%) had AMI, 2 (1.2%) underwent surgery, and 12(7.4%) died. Also, 9 (5.6%) had stroke and 30 (18.6%) had angina. As regards the mental component, 72.7 % and 25.5% had their condition improved and worsened, respectively. As regards the physical component, 82.6% and 16.1% had their condition improved and worsened, respectively. Angioplasty: 18 patients (10.9%) had AMI, 51 (30.7%) underwent interventions, and 18 (19.9%) died. Additionally, six (3.6%) presented stroke and 35 (21%) reported angina. As regards the mental component, 66.9% and 26.5% had their condition improved and worsened, respectively. As regards the physical component, 77.1% and 20.5% had their condition improved and worsened, respectively. CONCLUSION: Improvement was observed in all domains and in the three therapeutic modalities. Comparatively, surgery had provided a better quality of life after a four-year follow-up.

Qualidade de vida após revascularização cirúrgica do miocárdio, angioplastia ou tratamento clínico / Quality of life after surgical myocardial revascularization, angioplasty or medical treatment

FUNDAMENTO: Ainda que os benefícios clínicos das intervenções coronarianas parecem confirmados, seus efeitos na qualidade de vida (QV) permanecem pouco estudados. OBJETIVO: Avaliar a qualidade de vida (QV) na doença multiarterial coronariana em pacientes submetidos randomicamente a cirurgia, angioplastia ou tratamento clínico. MÉTODOS: Foi utilizando Short-Form Health Survey (SF36) questionnaire em 483 pacientes. Desses, 161 foram revascularizados; 166 receberam angioplastia e 153 tiveram tratamento clínico. RESULTADOS: Na internação, 86 por cento referiam angina; 34 por cento, infarto; e 32 por cento fumavam. Tratamento clínico: 12 pacientes (7,7 por cento) tiveram infarto agudo do miocárdio (IAM); 24 (15,3 por cento) receberam cirurgia; e 19 (12,1 por cento) morreram. Além disso, cinco (3,2 por cento) sofreram AVC e 40 (25,6 por cento) tinham angina. No componente mental, 64,1 por cento melhoram e 30,8 por cento pioram a condição. No componente físico, 70,5 por cento melhoram e 27,6 por cento pioram a condição. Cirurgia: 13 pacientes (8,1 por cento) tiveram IAM, dois (1,2 por cento) receberam cirurgia; 12 (7,4 por cento) morreram. Em adição, nove (5,6 por cento) sofreram AVC e 30 (18,6 por cento) sofriam angina. No componente mental, 72,7 por cento melhoram e 25,5 por cento pioram a condição. No componente físico, 82,6 por cento melhoram e 16,1 por cento pioram a condição. Angioplastia: 18 pacientes (10,9 por cento) tiveram IAM, 51 (30,7 por cento) receberam intervenções e 18 (19,9 por cento) morreram. Além disso, seis (3,6 por cento) sofreram AVC e 35 (21 por cento) relatavam angina. No componente mental, 66,9 por cento melhoram e 26,5 por cento pioram a condição No componente físico, 77,1 por cento melhoram e 20,5 por cento pioram a condição. CONCLUSÃO: Observou-se melhora em todos os domínios e nas três opções terapêuticas. Comparativamente, a cirurgia ofereceu melhor qualidade de vida após quatro anos de seguimento.

BACKGROUND: Although the clinical benefits of coronary interventions seem to be confirmed, their effects on quality of life (QoL) are still scarcely studied. OBJECTIVE: To assess the QoL in multivessel coronary disease in patients randomly undergoing surgery, angioplasty or medical treatment. METHODS: The Short-Form Health Survey (SF-36) questionnaire was answered by 483 patients. Of these, 161 underwent surgical revascularization, 166 underwent angioplasty, and 153 were medically treated. RESULTS: At baseline, 86 percent of the patients referred angina, 34 percent referred infarction, and 32 percent were smokers. Medical Treatment: 12 patients (7.7 percent) had AMI, 24 (15.3 percent) underwent surgery, and 19 (12.1 percent) died. In addition, 5 (3.2 percent) had stroke, and 40 (25.6 percent) had angina. As regards the mental component, 64.1 percent and 30.8 percent had their condition improved and worsened, respectively. As regards the physical component, 70.5 percent and 27.6 percent had their condition improved and worsened, respectively. Surgery: 13 patients (8.1 percent) had AMI, 2 (1.2 percent) underwent surgery, and 12(7.4 percent) died. Also, 9 (5.6 percent) had stroke and 30 (18.6 percent) had angina. As regards the mental component, 72.7 percent and 25.5 percent had their condition improved and worsened, respectively. As regards the physical component, 82.6 percent and 16.1 percent had their condition improved and worsened, respectively. Angioplasty: 18 patients (10.9 percent) had AMI, 51 (30.7 percent) underwent interventions, and 18 (19.9 percent) died. Additionally, six (3.6 percent) presented stroke and 35 (21 percent) reported angina. As regards the mental component, 66.9 percent and 26.5 percent had their condition improved and worsened, respectively. As regards the physical component, 77.1 percent and 20.5 percent had their condition improved and worsened, respectively. CONCLUSION: Improvement was observed in all domains...