Five-Year Outcomes after Off-Pump or On-Pump Coronary-Artery Bypass Grafting.

BACKGROUND: We previously reported that there was no significant difference at 30 days or at 1 year in the rate of the composite outcome of death, stroke, myocardial infarction, or renal failure between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report the results at 5 years (the end of the trial). METHODS: A total of 4752 patients (from 19 countries) who had coronary artery disease were randomly assigned to undergo off-pump or on-pump CABG. For this report, we analyzed a composite outcome of death, stroke, myocardial infarction, renal failure, or repeat coronary revascularization (either CABG or percutaneous coronary intervention). The mean follow-up period was 4.8 years. RESULTS: There were no significant differences between the off-pump group and the on-pump group in the rate of the composite outcome (23.1% and 23.6%, respectively; hazard ratio with off-pump CABG, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72) or in the rates of the components of the outcome, including repeat coronary revascularization, which was performed in 2.8% of the patients in the off-pump group and in 2.3% of the patients in the on-pump group (hazard ratio, 1.21; 95% CI, 0.85 to 1.73; P=0.29). The secondary outcome for the overall period of the trial - the mean cost in U.S. dollars per patient - also did not differ significantly between the off-pump group and the on-pump group ($15,107 and $14,992, respectively; between-group difference, $115; 95% CI, -$697 to $927). There were no significant between-group differences in quality-of-life measures. CONCLUSIONS: In our trial, the rate of the composite outcome of death, stroke, myocardial infarction, renal failure, or repeat revascularization at 5 years of follow-up was similar among patients who underwent off-pump CABG and those who underwent on-pump CABG. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294 .).

Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery.

BACKGROUND: Uncertainty remains regarding the benefits and risks of the technique of operating on a beating heart (off pump) for coronary artery bypass grafting (CABG) surgery versus on-pump CABG. Prior trials had few events and relatively short follow-up. There is a need for a large randomized, controlled trial with long-term follow-up to inform both the short- and long-term impact of the 2 approaches to CABG. METHODS: We plan to randomize 4,700 patients in whom CABG is planned to undergo the procedure on pump or off pump. The coprimary outcomes are a composite of total mortality, myocardial infarction (MI), stroke, and renal failure at 30 days and a composite of total mortality, MI, stroke, renal failure, and repeat revascularization at 5 years. We will also undertake a cost-effectiveness analysis at 30 days and 5 years after CABG surgery. Other outcomes include neurocognitive dysfunction, recurrence of angina, cardiovascular mortality, blood transfusions, and quality of life. RESULTS: As of May 3, 2011, CORONARY has recruited >3,884 patients from 79 centers in 19 countries. Currently, patient's mean age is 67.6 years, 80.7% are men, 47.0% have a history of diabetes, 51.4% have a history of smoking, and 34.4% had a previous MI. In addition, 20.9% of patients have a left main disease, and 96.6% have double or triple vessel disease. CONCLUSIONS: CORONARY is the largest trial yet conducted comparing off-pump CABG to on-pump CABG. Its results will lead to a better understanding of the safety and efficacy of off-pump CABG.

Cirurgia de revascularização miocárdica: resultados do Sistema Único de Saúde / Myocardial revascularization surgery (MRS): results from National Health System (SUS) / Cirugía de revascularización miocárdica: resultados del Sistema Único de Salud

FUNDAMENTO: A cirurgia de revascularização do miocárdio (CRM) é a cirurgia cardíaca mais frequentemente praticada no país, sendo a maior parte realizada pelo Sistema Único de Saúde (SUS). OBJETIVO: Avaliar os resultados da CRM, não associada a outros procedimentos. MÉTODOS: Analisaram-se as informações do banco de dados SIH/DATASUS, disponibilizado on-line. Esse banco de dados contém informações relativas a: sexo, idade, permanência hospitalar, valor da autorização de internação hospitalar (AIH), número de cirurgias realizadas por hospital e mortalidade hospitalar. Avaliaram-se apenas as CRM realizadas sem procedimentos associados. RESULTADOS: Entre 2005 e 2007 foram realizadas 63.529 cirurgias em 191 hospitais. Foram excluídos 16 hospitais de muito baixo volume cirúrgico, restando 63.272 cirurgias para análise final. A mortalidade hospitalar total foi de 6,22 por cento, sendo maior nos hospitais de pequeno volume do que nos de grande volume (> 300 cirurgias no período), 7,29 por cento versus 5,77 por cento (p<0,001). A média de permanência hospitalar foi de 12 dias, não havendo diferença entre os de pequeno (12,08±5,52) e de grande volume (12,15±7,70). O gênero masculino teve menor mortalidade do que o feminino, 5,20 por cento versus 8,25 por cento (p<0,001), assim como os mais jovens quando comparados com os idosos (> 65 anos), 4,21 por cento versus 9,36 por cento (p<0,001). Encontrou-se uma pequena variação no valor da AIH entre a região Sul, R$ 7.214,63 e Nordeste, R$ 6.572,03 (p<0,01). A distribuição regional de cirurgias foi desigual, Sul e Sudeste concentram 77 por cento delas. CONCLUSÃO: A CRM realizada pelo SUS tem mortalidade maior nos hospitais de baixo volume, nas mulheres e nos idosos. Futuros estudos prospectivos se fazem necessários.

BACKGROUND: Myocardial revascularization surgery (MRS) is the most common surgery in this country, with most being performed through the National Health System(SUS). OBJECTIVES: To assess MRS results when not associated to other procedures. METHODS: The information from the Hospital Information System (SIH/DATASUS) made available online was submitted to analysis. The data include information on gender, age, hospital stay period, hospital admission authorization (AIH) costs, number of surgeries at each hospital, and in-hospital mortality rate. Only MRS with no associated procedures were analyzed. RESULTS: A total of 63,529 surgeries were performed in the period between 2005 and 2007 at 191 hospitals. Sixteen hospitals reporting very low surgery volume were excluded. The remaining total number of surgeries came down to 63,272 for the final analysis. In-hospital mortality rate was 6.22 percent, with small surgery volume hospitals reporting higher rate than high volume hospitals (≥300 surgeries in the time period under study), 7.29 percent versus 5.77 percent (p<0.001). Average hospital stay time length was 12 days, with no difference having been reported between low (12.08±5.52) and high volume (12.15±7.70) hospitals. Males reported lower mortality rate than females - 5.20 percent versus 8.25 percent (p<0.001), similarly to younger individuals when compared to the elderly (≥ 65 years of age), 4.21 percent versus 9.36 percent (p<0.001). A slight variation was observed in AIH values between the Southern Region (R$ 7.214,63 - approximately US$ 3,600.00) and the Northeastern Region (R$ 6.572,03 - approximately US$ 3,280.00) (p<0.01). Regional distribution of surgeries was not comparable in all regions in the country, with Southern and Southeastern Regions having reported 77 percent of them. CONCLUSION: MRS performed by SUS has reported high mortality rate in low volume hospitals, among women, and among the elderly. Future ...

FUNDAMENTO: La cirugía de revascularización de miocardio (CRM) es la cirugía cardiaca más frecuentemente practicada en el país, con la mayor parte realizada por el Sistema Único de Salud (SUS). OBJETIVO: Evaluar los resultados de la CRM no asociada a otros procedimientos. MÉTODOS: Se analizaron las informaciones del banco de datos SIH/DATASUS, disponible online. Este banco de datos contiene informaciones relativas a: sexo, edad, permanencia hospitalaria, valor de la autorización de internación hospitalaria (AIH), número de cirugías realizadas por hospital y mortalidad hospitalaria. Se evaluaron solamente las CRM realizadas sin procedimientos asociados. RESULTADOS: Entre 2005 y 2007 se llevaron a cabo 63.529 cirugías en 191 hospitales. Se excluyeron 16 hospitales de muy bajo volumen quirúrgico, restando 63.272 cirugías para análisis final. La mortalidad hospitalaria total fue del 6,22 por ciento, con mayor índice en los hospitales de pequeño volumen que en los de gran volumen (≥300 cirugías en el período), el 7,29 por ciento versus el 5,77 por ciento (p<0,001). El promedio de permanencia hospitalaria fue de 12 días, sin diferencia entre los de pequeño (12,08±5,52) y de gran volumen (12,15±7,70). El género masculino tuvo menor mortalidad que el femenino, el 5,20 por ciento versus el 8,25 por ciento (p<0,001), así como los más jóvenes cuando comparados con los adultos mayores (≥ 65 años), el 4,21 por ciento versus el 9,36 por ciento (p<0,001). Se encontró una pequeña variación en el valor de la AIH entre la región Sur, R$ 7.214,63 y Nordeste, R$ 6.572,03 (p<0,01). La distribución regional de cirugías fue desigual, Sur y Sudeste concentran el 77 por ciento de ellas. CONCLUSIÓN: La CRM realizada por el SUS tiene mortalidad mayor en los hospitales de bajo volumen, en las mujeres y en los adultos mayores. Futuros estudios prospectivos se hacen necesarios.

Glucose levels compared with diabetes history in the risk assessment of patients with acute myocardial infarction.

BACKGROUND: Both a history of diabetes mellitus and elevated inhospital glucose levels predict death after acute myocardial infarction (AMI). However, only diabetes history (and not glucose levels) is routinely considered in AMI risk assessment. METHODS: We conducted a post hoc analysis of 2 randomized controlled trials of AMI with ST-segment elevation to compare the prognostic value of inhospital glucose levels with diabetes history in 30,536 subjects. Average inhospital glucose (mean of glucose levels at admission, 6 hours, and 24 hours), diabetes history, and death at 30 days (occurring in 2,808 subjects) were documented. RESULTS: Average glucose predicted 30-day death (OR 1.10 per 1-mmol/L [18-mg/dL] increase, 95% CI 1.09-1.11, P < .0001); this was unchanged after adjusting for diabetes history. In contrast, diabetes history alone predicted 30-day death (OR 1.63, 95% CI 1.48-1.78, P < .0001), but not after adjusting for average glucose (OR 0.98, 95% CI 0.88-1.09, P = .72). The C-indices (areas under the receiver operating characteristic curves) for 30-day death were 0.54 for diabetes history alone, 0.64 for average glucose alone, and 0.64 for glucose plus diabetes. Higher glucose levels predicted death in patients with and without diabetes history, but this relationship was more steep in nondiabetic subjects such that their rate of 30-day death (13.2%) matched that of diabetic patients (13.7%) when average glucose was > or =144 mg/dL (8 mmol/L) (P = .55 after multivariable adjustment). CONCLUSIONS: Although diabetes history is routinely considered in the risk stratification of AMI patients, inhospital glucose levels are a much stronger predictor of death and should be incorporated in their risk assessment. Patients with AMI with inhospital glucose > or =144 mg/dL have a very high risk of death regardless of diabetes history.

Myocardial revascularization surgery (MRS): results from national health system (SUS).

BACKGROUND: Myocardial revascularization surgery (MRS) is the most common surgery in this country, with most being performed through the National Health System(SUS). OBJECTIVES: To assess MRS results when not associated to other procedures. METHODS: The information from the Hospital Information System (SIH/DATASUS) made available online was submitted to analysis. The data include information on gender, age, hospital stay period, hospital admission authorization (AIH) costs, number of surgeries at each hospital, and in-hospital mortality rate. Only MRS with no associated procedures were analyzed. RESULTS: A total of 63,529 surgeries were performed in the period between 2005 and 2007 at 191 hospitals. Sixteen hospitals reporting very low surgery volume were excluded. The remaining total number of surgeries came down to 63,272 for the final analysis. In-hospital mortality rate was 6.22%, with small surgery volume hospitals reporting higher rate than high volume hospitals (>or=300 surgeries in the time period under study), 7.29% versus 5.77% (p<0.001). Average hospital stay time length was 12 days, with no difference having been reported between low (12.08+/-5.52) and high volume (12.15+/-7.70) hospitals. Males reported lower mortality rate than females - 5.20% versus 8.25% (p<0.001), similarly to younger individuals when compared to the elderly (>or= 65 years of age), 4.21% versus 9.36% (p<0.001). A slight variation was observed in AIH values between the Southern Region (R$ 7.214,63 - approximately US$ 3,600.00) and the Northeastern Region (R$ 6.572,03 - approximately US$ 3,280.00) (p<0.01). Regional distribution of surgeries was not comparable in all regions in the country, with Southern and Southeastern Regions having reported 77% of them. CONCLUSION: MRS performed by SUS has reported high mortality rate in low volume hospitals, among women, and among the elderly. Future prospective studies are deemed to be necessary.