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PURPOSE: To assess the association between acute disease severity and 1-year quality of life in patients discharged after hospitalisation due to coronavirus disease 2019 (COVID-19). METHODS: We conducted a prospective cohort study nested in 5 randomised clinical trials between March 2020 and March 2022 at 84 sites in Brazil. Adult post-hospitalisation COVID-19 patients were followed for 1 year. The primary outcome was the utility score of EuroQol five-dimension three-level (EQ-5D-3L). Secondary outcomes included all-cause mortality, major cardiovascular events, and new disabilities in instrumental activities of daily living. Adjusted generalised estimating equations were used to assess the association between outcomes and acute disease severity according to the highest level on a modified ordinal scale during hospital stay (2: no oxygen therapy; 3: oxygen by mask or nasal prongs; 4: high-flow nasal cannula oxygen therapy or non-invasive ventilation; 5: mechanical ventilation). RESULTS: 1508 COVID-19 survivors were enrolled. Primary outcome data were available for 1156 participants. At 1 year, compared with severity score 2, severity score 5 was associated with lower EQ-5D-3L utility scores (0.7 vs 0.84; adjusted difference, - 0.1 [95% CI - 0.15 to - 0.06]); and worse results for all-cause mortality (7.9% vs 1.2%; adjusted difference, 7.1% [95% CI 2.5%-11.8%]), major cardiovascular events (5.6% vs 2.3%; adjusted difference, 2.6% [95% CI 0.6%-4.6%]), and new disabilities (40.4% vs 23.5%; adjusted difference, 15.5% [95% CI 8.5%-22.5]). Severity scores 3 and 4 did not differ consistently from score 2. CONCLUSIONS: COVID-19 patients who needed mechanical ventilation during hospitalisation have lower 1-year quality of life than COVID-19 patients who did not need mechanical ventilation during hospitalisation.

Asunto(s)

COVID-19 , Enfermedades Cardiovasculares , Adulto , Humanos , SARS-CoV-2 , Calidad de Vida , Actividades Cotidianas , Estudios Prospectivos , Respiración Artificial , Hospitalización , Gravedad del Paciente

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IMPORTANCE: The long-term prognostic implications of myocardial ischemia documented during stress testing in patients with multivessel coronary artery disease (CAD) are unclear. OBJECTIVE: To assess whether documented stress testing-induced myocardial ischemia is associated with major adverse cardiovascular events or ventricular function changes in patients with stable multivessel CAD. DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study was conducted using data from a single-center randomized clinical trial (Medicine, Angioplasty, or Surgery Study [MASS] II) to examine the association of myocardial ischemia documented during stress testing at baseline with cardiovascular events and ventricular function changes during follow-up. Participants were previously randomized (May 1, 1995, to May 31, 2000) to medical therapy, percutaneous coronary intervention with bare metal stents, or coronary artery bypass grafting. Event-free survival was estimated by the Kaplan-Meier method, and multivariable Cox regression models were calculated to assess the association between ischemia and the primary composite end point. The vital status was determined on February 28, 2011. Data were analyzed from February 1, 2016, to April 1, 2017. MAIN OUTCOMES AND MEASURES: Cardiovascular events (overall mortality, myocardial infarction, and revascularization for refractory angina) were tracked from the time of randomization to the end of the 10-year follow-up (mean [SD] duration, 11.4 [4.3] years). Myocardial ischemia was assessed at baseline and at 1-year intervals by exercise stress testing, and ventricular function (left ventricular ejection fraction) was assessed by echocardiography at baseline and after 10 years. Patients with documented ischemia were compared with those without ischemia regarding the outcomes and changes in ventricular function. RESULTS: Of 611 participants, 535 underwent exercise stress testing at baseline: 270 with documented ischemia and 265 without. Of these 535 patients, 373 (69.7%) were men, and the mean (SD) age for the entire cohort was 59.7 (9.2) years. No association was found between the presence of ischemia at baseline and survival free of combined cardiovascular events (hazard ratio, 1.00; 95% CI, 0.80-1.27; P = .95) after multivariable adjustment that included CAD initial randomized treatments. In addition, among 320 patients who underwent echocardiographic evaluation, the slight decline in left ventricular ejection fraction after 10 years was similar in both groups (median [SD] difference, -4.9% [18.7%] vs -6.6% [20.0%], respectively, for groups with and without ischemia; P = .97). CONCLUSIONS AND RELEVANCE: In this study, regardless of the therapeutic strategy applied, the presence of documented myocardial ischemia did not appear to be associated with an increased occurrence of major adverse cardiovascular events or changes in ventricular function in patients with multivessel CAD during a long-term follow-up.

RESUMEN

It was a randomized trial, and 308 patients undergoing revascularization were randomly assigned: 155 to off-pump coronary artery bypass (OPCAB) and 153 to on-pump coronary artery bypass (ONCAB). End points were freedom from death, myocardial infarction, revascularization, and cerebrovascular accidents. The rates for 10-year, event-free survival for ONCAB versus OPCAB were 69.6% and 64%, (hazard ratio [HR]: 0.88; 95% confidence interval [CI] 0.86-1.02; P = .41), respectively. Adjusted Cox proportional hazard ratio was similar (HR: 0.92; 95% CI 0.61-1.38, P = .68). A difference occurred between the duration of OPCAB and ONCAB, respectively (4.9 ± 1.5 vs 6.6 ± 1.1 h, P < .001). Statistical differences occurred between OPCAB and ONCAB in the length of intensive care unit (ICU) stay (20 ± 2.5 vs 48 ± 10 hours, P < .001), time to extubation (5.5 ± 4.2 vs 10.2 ± 3.5 hours, P < .001), hospital stay (6.7 ± 1.4 vs 9.2 ± 1.3 days, P < .001), higher incidence of atrial fibrillation (AF; 33 vs 5 patients, P < .001), and blood requirements (46 vs 64 patients, P < .001). Grafts per patient was higher in ONCAB (3.15 vs 2.55 grafts, P < .001). No difference existed between the groups in primary composite end points at 10-year follow-up. Although OPCAB surgery was related to a lower number of grafts and higher incidence of AF, it had no effects related to long-term outcomes.

Asunto(s)

Puente Cardiopulmonar , Puente de Arteria Coronaria Off-Pump , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Estenosis Coronaria/cirugía , Anciano , Puente Cardiopulmonar/efectos adversos , Puente Cardiopulmonar/mortalidad , Puente de Arteria Coronaria/efectos adversos , Puente de Arteria Coronaria/mortalidad , Puente de Arteria Coronaria Off-Pump/efectos adversos , Puente de Arteria Coronaria Off-Pump/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Supervivencia sin Progresión , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

OBJECTIVE: To assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. METHODS: There were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model. Results Patients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/ systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory. CONCLUSIONS: In anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.

Asunto(s)

Válvula Aórtica , Fibrilación Atrial , Enfermedades de las Válvulas Cardíacas , Anticoagulantes

RESUMEN

BACKGROUND: Prior studies have demonstrated a link between the metabolic syndrome and increased risk of cardiovascular mortality. Whether the metabolic syndrome is associated with sudden cardiac death is uncertain. METHODS AND RESULTS: We characterized the relationship between sudden cardiac death and metabolic syndrome status among participants of the ARIC (Atherosclerosis Risk in Communities) Study (1987-2012) free of prevalent coronary heart disease or heart failure. Among 13 168 participants, 357 (2.7%) sudden cardiac deaths occurred during a median follow-up of 23.6 years. Participants with the metabolic syndrome (n=4444) had a higher cumulative incidence of sudden cardiac death than those without it (n=8724) (4.1% versus 2.3%, P<0.001). After adjustment for participant demographics and clinical factors other than components of the metabolic syndrome, the metabolic syndrome was independently associated with sudden cardiac death (hazard ratio, 1.70, 95% confidence interval, 1.37-2.12, P<0.001). This relationship was not modified by sex (interaction P=0.10) or race (interaction P=0.62) and was mediated by the metabolic syndrome criteria components. The risk of sudden cardiac death varied according to the number of metabolic syndrome components (hazard ratio 1.31 per additional component of the metabolic syndrome, 95% confidence interval, 1.19-1.44, P<0.001). Of the 5 components, elevated blood pressure, impaired fasting glucose, and low high-density lipoprotein were independently associated with sudden cardiac death. CONCLUSIONS: We observed that the metabolic syndrome was associated with a significantly increased risk of sudden cardiac death irrespective of sex or race. The risk of sudden cardiac death was proportional to the number of metabolic syndrome components.

Asunto(s)

Aterosclerosis/mortalidad , Muerte Súbita Cardíaca/epidemiología , Síndrome Metabólico/mortalidad , Aterosclerosis/sangre , Aterosclerosis/diagnóstico , Aterosclerosis/fisiopatología , Biomarcadores/sangre , Glucemia/metabolismo , Presión Sanguínea , Dislipidemias/sangre , Dislipidemias/mortalidad , Femenino , Trastornos del Metabolismo de la Glucosa/sangre , Trastornos del Metabolismo de la Glucosa/mortalidad , Humanos , Hipertensión/mortalidad , Hipertensión/fisiopatología , Incidencia , Lipoproteínas LDL/sangre , Masculino , Síndrome Metabólico/sangre , Síndrome Metabólico/diagnóstico , Síndrome Metabólico/fisiopatología , Persona de Mediana Edad , Prevalencia , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Estados Unidos

RESUMEN

TOPCAT was a multinational clinical trial of 3,445 heart failure with preserved ejection fraction (HFpEF) patients that enrolled in 233 sites in six countries in North America, Eastern Europe and South America. Patients with a heart failure hospitalization in the last 12 months or an elevated B-type natriuretic peptide (BNP) were randomized to the mineralocorticoid receptor antagonist spironolactone vs. placebo. Sites in Russia and the Republic of Georgia provided the majority of early enrollment, primarily based on the hospitalization criterion since BNP levels were initially unavailable there. With the emergence of country-specific aggregate event rate data indicating lower rates in Eastern Europe and differences in patient characteristics there, the DSMB recommended relatively increasing enrollment in North America plus other corrective measures. Although final enrollment reflected the increased contribution from North America, a plurality of the final cohort came from Russia and Georgia (49% vs. 43% in North America). BNP measurements from Russia and Georgia available later in the trial suggested no or a mild level of heart failure consistent with low event rates. The primary results showed no significant spironolactone treatment effect overall (primary endpoint hazard ratio 0.89 (0.77, 1.04)), with a significant hazard ratio in North and South America (0.82 (0.69, 0.98), p =0.026) but not in Russia and Georgia (1.10 (0.79, 1.51), interaction p = 0.12). This report describes the DSMB's detection and management recommendations for regional differences in patient characteristics in TOPCAT, and suggests methods of surveillance and corrective actions that may be useful for future trials.

RESUMEN

BACKGROUND: Coronary artery disease (CAD) among patients with diabetes and chronic kidney disease (CKD) is not well studied, and the best treatment for this condition is not established. Our aim was to compare three therapeutic strategies for CAD in diabetic patients stratified by renal function. METHODS: Patients with multivessel CAD that underwent coronary artery bypass graft (CABG), angioplasty (percutaneous coronary intervention [PCI]), or medical therapy alone (MT) were included. Data were analyzed according to glomerular filtration rate in three strata: normal (>90 mL/min), mild CKD (60 to 89 mL/min), and moderate CKD (30 to 59 mL/min). End points comprised overall rate of mortality, acute myocardial infarction, and need for additional revascularization. RESULTS: Among patients with normal renal function (n = 270), 122 underwent CABG, 72 PCI, and 76 MT; among patients with mild CKD (n = 367), 167 underwent CABG, 92 PCI, and 108 MT; and among patients with moderate CKD (n = 126), 46 underwent CABG, 40 PCI, and 40 MT. Event-free survival was 80.4%, 75.7%, 67.5% for strata 1, 2, and 3, respectively (p = 0.037). Survival rates among patients with no, mild, and moderate CKD are 91.1%, 89.6%, and 76.2%, respectively (p = 0.001) (hazard ratio 0.69; 95% confidence interval 0.51 to 0.95; p = 0.024 for stratum 1 versus 3). We found no differences for overall number of deaths or acute myocardial infarctions irrespective of strata. The need of new revascularization was different in all strata, favoring CABG (p < 0.001, p < 0.001, and p = 0.029 for no, mild, and moderate CKD, respectively). CONCLUSIONS: Mortality rates were higher in patients with mild and moderate CKD. Higher event-free survival was observed in the CABG group among patients with no and mild CKD. Besides, CABG was associated with less need for new revascularization compared with PCI and MT in all renal function strata. This trial was registered at http://www.controlled-trials.com as ISRCTN66068876.

Asunto(s)

Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/terapia , Diabetes Mellitus Tipo 2/complicaciones , Intervención Coronaria Percutánea , Insuficiencia Renal Crónica/mortalidad , Anciano , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/fisiopatología , Diabetes Mellitus Tipo 2/fisiopatología , Femenino , Tasa de Filtración Glomerular , Humanos , Masculino , Persona de Mediana Edad , Tasa de Supervivencia , Resultado del Tratamiento

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El aumento de la edad se destaca como uno de los factores de riesgo más potentes para la aparición de un accidente cerebrovascular en un paciente con fibrilación auricular (FA). Con el aumento constante de la edad de la población mundial se plantean muchas interrogantes acerca de la estrategia óptima para anticoagular al paciente añoso, y a menudo se presentan dilemas sumamente complejos. Este grupo de pacientes tiene un mayor riesgo de sangrado vinculado a la presencia de múltiples comorbilidades, por la frecuencia de las caídas y la polifarmacia -en especial por los antiplaquetarios-. La mayor sensibilidad del paciente añoso a la warfarina, junto con la mayor frecuencia con la que sufren sangrado intracraneano, hacen que los nuevos anticoagulantes orales constituyan una alternativa atractiva en ciertos subgrupos seleccionados. Esta revisión intenta contextualizar el problema, brindando un enfoque práctico y equilibrado para manejar el ineludible aprieto de sopesar la posibilidad de sangrado contra el accidente cerebrovascular tromboembólico en este grupo de alto riesgo.

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Increasing age stands out as one of the most powerful risk factors for stroke in patients with atrial fibrillation. With the steadily increasing age of the global population, questions regarding the optimal anticoagulation strategy in the elderly are pervasive and often present highly complex clinical dilemmas. This group of patients is at increased risk of bleeding related to multiple other comorbidities, higher rates of falling, and polypharmacy -especially the anti-platelet agents. The elderly patient is more sensitive to warfarin, and coupled with higher rates of intracranial bleeding, the newer anticoagulants present an attractive alternative in selected subgroups. This review is aimed at contextualizing the problem, and providing a practical, balanced approach to managing the inescapable predicament of bleeding versus thromboembolic stroke in this high-risk group.

RESUMEN

Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrialfibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation(ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients withclinically significant mitral stenosis or mechanical prosthetic heart valves.Methods and Results—We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, majorbleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazardsmodeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heartdisease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolismand bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban overwarfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR],0.70; 95% confidence interval [CI], 0.51–0.97 and HR, 0.84; 95%, CI 0.67–1.04; interaction P=0.38), causing less majorbleeding (HR, 0.79; 95% CI, 0.61–1.04 and HR, 0.65; 95% CI, 0.55–0.77; interaction P=0.23), and reducing mortality(HR, 1.01; 95% CI, 0.84–1.22 and HR, 0.84; 95% CI, 0.73–0.96; interaction P=0.10).Conclusions—More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severevalvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke orsystemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease.

Asunto(s)

Accidente Cerebrovascular , Enfermedades Cardiovasculares , Fibrilación Atrial , Inhibidor de Coagulación del Lupus

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BACKGROUND: Assuming that coronary interventions, both coronary bypass surgery (CABG) and percutaneous coronary intervention (PCI), are directed to preserve left ventricular function, it is not known whether medical therapy alone (MT) can achieve this protection. Thus, we evaluated the evolution of LV ejection fraction (LVEF) in patients with stable coronary artery disease (CAD) treated by CABG, PCI, or MT as a post hoc analysis of a randomized controlled trial with a follow-up of 10 years. METHODS: Left ventricle ejection fraction was assessed with transthoracic echocardiography in patients with multivessel CAD, participants of the MASS II trial before randomization to CABG, PCI, or MT, and re-evaluated after 10 years of follow-up. RESULTS: Of the 611 patients, 422 were alive after 10.32 ± 1.43 years. Three hundred and fifty had LVEF reassessed: 108 patients from MT, 111 from CABG, and 131 from PCI. There was no difference in LVEF at the beginning (0.61 ± 0.07, 0.61 ± 0.08, 0.61 ± 0.09, respectively, for PCI, CABG, and MT, P = 0.675) or at the end of follow-up (0.56 ± 0.11, 0.55 ± 0.11, 0.55 ± 0.12, P = 0.675), or in the decline of LVEF (reduction delta of -7.2 ± 17.13, -9.08 ± 18.77, and -7.54 ± 22.74). Acute myocardial infarction (AMI) during the follow-up was associated with greater reduction in LVEF. The presence of previous AMI (OR: 2.50, 95% CI: 1.40-4.45; P = 0.0007) and during the follow-up (OR: 2.73, 95% CI: 1.25-5.92; P = 0.005) was associated with development of LVEF <45%. CONCLUSION: Regardless of the therapeutic option applied, LVEF remains preserved in the absence of a major adverse cardiac event after 10 years of follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Registration number ISRCTN66068876.

Asunto(s)

Fármacos Cardiovasculares/uso terapéutico , Puente de Arteria Coronaria , Estenosis Coronaria/terapia , Intervención Coronaria Percutánea , Volumen Sistólico/fisiología , Anciano , Análisis de Varianza , Estenosis Coronaria/fisiopatología , Ecocardiografía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/fisiopatología , Revascularización Miocárdica/métodos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/fisiopatología , Resultado del Tratamiento , Disfunción Ventricular Izquierda/etiología , Disfunción Ventricular Izquierda/fisiopatología

RESUMEN

BACKGROUND: The importance of complete revascularization remains unclear and contradictory. This current investigation compares the effect of complete revascularization on 10-year survival of patients with stable multivessel coronary artery disease (CAD) who were randomly assigned to percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). METHODS AND RESULTS: This is a post hoc analysis of the Second Medicine, Angioplasty, or Surgery Study (MASS II), which is a randomized trial comparing treatments in patients with stable multivessel CAD, and preserved systolic ventricular function. We analyzed patients who underwent surgery (CABG) or stent angioplasty (PCI). The survival free of overall mortality of patients who underwent complete (CR) or incomplete revascularization (IR) was compared. Of the 408 patients randomly assigned to mechanical revascularization, 390 patients (95.6%) underwent the assigned treatment; complete revascularization was achieved in 224 patients (57.4%), 63.8% of those in the CABG group and 36.2% in the PCI group (P=0.001). The IR group had more prior myocardial infarction than the CR group (56.2% × 39.2%, P=0.01). During a 10-year follow-up, the survival free of cardiovascular mortality was significantly different among patients in the 2 groups (CR, 90.6% versus IR, 84.4%; P=0.04). This was mainly driven by an increased cardiovascular specific mortality in individuals with incomplete revascularization submitted to PCI (P=0.05). CONCLUSIONS: Our study suggests that in 10-year follow-up, CR compared with IR was associated with reduced cardiovascular mortality, especially due to a higher increase in cardiovascular-specific mortality in individuals submitted to PCI. CLINICAL TRIAL REGISTRATION INFORMATION: URL: http://www.controlled-trials.com. REGISTRATION NUMBER: ISRCTN66068876.

Asunto(s)

Puente de Arteria Coronaria/estadística & datos numéricos , Enfermedad Coronaria/cirugía , Estudios Multicéntricos como Asunto/estadística & datos numéricos , Complicaciones Posoperatorias/mortalidad , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Anciano , Angina de Pecho/epidemiología , Angina de Pecho/cirugía , Angioplastia Coronaria con Balón/estadística & datos numéricos , Enfermedades Cardiovasculares/mortalidad , Causas de Muerte , Enfermedad Coronaria/terapia , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Reoperación , Stents , Resultado del Tratamiento

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BACKGROUND: Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis. METHODS/DESIGN: The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR. DISCUSSION: The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.

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Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Forma MB de la Creatina-Quinasa/sangre , Cardiopatías/diagnóstico , Imagen por Resonancia Cinemagnética , Miocardio , Intervención Coronaria Percutánea/efectos adversos , Proyectos de Investigación , Troponina I/sangre , Biomarcadores/sangre , Distribución de Chi-Cuadrado , Puente de Arteria Coronaria Off-Pump/efectos adversos , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/patología , Enfermedad de la Arteria Coronaria/cirugía , Fibrosis , Cardiopatías/sangre , Cardiopatías/patología , Cardiopatías/fisiopatología , Humanos , Modelos Logísticos , Análisis Multivariante , Miocardio/metabolismo , Miocardio/patología , Necrosis , Intervención Coronaria Percutánea/instrumentación , Valor Predictivo de las Pruebas , Estudios Prospectivos , Stents , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Regulación hacia Arriba , Disfunción Ventricular Izquierda/diagnóstico , Disfunción Ventricular Izquierda/etiología , Disfunción Ventricular Izquierda/fisiopatología , Función Ventricular Izquierda

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INTRODUCTION: The primary end points of randomized clinical trials evaluating the outcome of therapeutic strategies for coronary artery disease (CAD) have included nonfatal acute myocardial infarction, the need for further revascularization, and overall mortality. Noncardiac causes of death may distort the interpretation of the long-term effects of coronary revascularization. MATERIALS AND METHODS: This post-hoc analysis of the second Medicine, Angioplasty, or Surgery Study evaluates the cause of mortality of patients with multivessel CAD undergoing medical treatment, percutaneous coronary intervention, or surgical myocardial revascularization [coronary artery bypass graft surgery (CABG)] after a 6-year follow-up. Mortality was classified as cardiac and noncardiac death, and the causes of noncardiac death were reported. RESULTS: Patients were randomized into CABG and non-CABG groups (percutaneous coronary intervention plus medical treatment). No statistical differences were observed in overall mortality (P=0.824). A significant difference in the distribution of causes of mortality was observed among the CABG and non-CABG groups (P=0.003). In the CABG group, of the 203 randomized patients, the overall number of deaths was 34. Sixteen patients (47.1%) died of cardiac causes and 18 patients (52.9%) died of noncardiac causes. Of these, seven deaths (20.6%) were due to neoplasia. In the non-CABG group, comprising 408 patients, the overall number of deaths was 69. Fifty-three patients (77%) died of cardiac causes and 16 patients (23%) died of noncardiac causes. Only five deaths (7.2%) were due to neoplasia. CONCLUSION: Different treatment options for multivessel coronary artery disease have similar overall mortality: CABG patients had the lowest incidence of cardiac death, but the highest incidence of noncardiac causes of death, and specifically a higher tendency toward cancer-related deaths.

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Enfermedad de la Arteria Coronaria/terapia , Neoplasias/mortalidad , Angioplastia Coronaria con Balón , Brasil/epidemiología , Causas de Muerte/tendencias , Enfermedad Crónica , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Estudios Prospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

BackgroundIn some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularizationapproach for patients with diabetes and multivessel coronary artery disease.MethodsIn this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control oflow-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.ResultsFrom 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients’ mean age was 63.1±9.1 years, 29% were women, and 83% had threevessel disease. The primary outcome occurred more frequently in the PCI group (P = 0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardialinfarction (P<0.001) and death from any cause (P = 0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P = 0.03).ConclusionsFor patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, (CT00086450.)

Asunto(s)

Enfermedad Coronaria , Revascularización Miocárdica , Stents

RESUMEN

BACKGROUND: The MASS IV-DM Trial is a large project from a single institution, the Heart Institute (InCor), University of São Paulo Medical School, Brazil to study ventricular function and coronary arteries in patients with type 2 diabetes mellitus. METHODS/DESIGN: The study will enroll 600 patients with type 2 diabetes who have angiographically normal ventricular function and coronary arteries. The goal of the MASS IV-DM Trial is to achieve a long-term evaluation of the development of coronary atherosclerosis by using angiograms and coronary-artery calcium scan by electron-beam computed tomography at baseline and after 5 years of follow-up. In addition, the incidence of major cardiovascular events, the dysfunction of various organs involved in this disease, particularly microalbuminuria and renal function, will be analyzed through clinical evaluation. In addition, an effort will be made to investigate in depth the presence of major cardiovascular risk factors, especially the biochemical profile, metabolic syndrome inflammatory activity, oxidative stress, endothelial function, prothrombotic factors, and profibrinolytic and platelet activity. An evaluation will be made of the polymorphism as a determinant of disease and its possible role in the genesis of micro- and macrovascular damage. DISCUSSION: The MASS IV-DM trial is designed to include diabetic patients with clinically suspected myocardial ischemia in whom conventional angiography shows angiographically normal coronary arteries. The result of extensive investigation including angiographic follow-up by several methods, vascular reactivity, pro-thrombotic mechanisms, genetic and biochemical studies may facilitate the understanding of so-called micro- and macrovascular disease of DM.

Asunto(s)

Enfermedad de la Arteria Coronaria/diagnóstico , Vasos Coronarios/metabolismo , Diabetes Mellitus Tipo 2/diagnóstico , Riñón/metabolismo , Proyectos de Investigación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/patología , Enfermedad de la Arteria Coronaria/fisiopatología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/inmunología , Vasos Coronarios/patología , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/patología , Diabetes Mellitus Tipo 2/fisiopatología , Estudios de Seguimiento , Predisposición Genética a la Enfermedad , Humanos , Inflamación , Riñón/inmunología , Riñón/patología , Síndrome Metabólico , Estrés Oxidativo , Polimorfismo Genético , Pronóstico , Trombosis , Ultrasonografía

RESUMEN

BACKGROUND: Coronary artery bypass graft surgery with cardiopulmonary bypass is a safe, routine procedure. Nevertheless, significant morbidity remains, mostly because of the body's response to the nonphysiological nature of cardiopulmonary bypass. Few data are available on the effects of off-pump coronary artery bypass graft surgery (OPCAB) on cardiac events and long-term clinical outcomes. METHODS AND RESULTS: In a single-center randomized trial, 308 patients undergoing coronary artery bypass graft surgery were randomly assigned: 155 to OPCAB and 153 to on-pump CAB (ONCAB). Primary composite end points were death, myocardial infarction, further revascularization (surgery or angioplasty), or stroke. After 5-year follow-up, the primary composite end point was not different between groups (hazard ratio 0.71, 95% CI 0.41 to 1.22; P=0.21). A statistical difference was found between OPCAB and ONCAB groups in the duration of surgery (240±65 versus 300±87.5 minutes; P<0.001), in the length of ICU stay (19.5±17.8 versus 43±17.0 hours; P<0.001), time to extubation (4.6±6.8 versus 9.3±5.7 hours; P<0.001), hospital stay (6±2 versus 9±2 days; P<0.001), higher incidence of atrial fibrillation (35 versus 4% of patients; P<0.001), and blood requirements (31 versus 61% of patients; P<0.001), respectively. The number of grafts per patient was higher in the ONCAB than the OPCAB group (2.97 versus 2.49 grafts/patient; P<0.001). CONCLUSIONS: No difference was found between groups in the primary composite end point at 5-years follow-up. Although OPCAB surgery was related to a lower number of grafts and higher episodes of atrial fibrillation, it had no significant implications related to long-term outcomes. Clinical Trial Registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN66068876.

Asunto(s)

Puente de Arteria Coronaria Off-Pump , Circulación Extracorporea , Fibrilación Atrial/etiología , Fibrilación Atrial/mortalidad , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Tasa de Supervivencia , Factores de Tiempo

RESUMEN

BACKGROUND: This study compared the 10-year follow-up of percutaneous coronary intervention (PCI), coronary artery surgery (CABG), and medical treatment (MT) in patients with multivessel coronary artery disease, stable angina, and preserved ventricular function. METHODS AND RESULTS: The primary end points were overall mortality, Q-wave myocardial infarction, or refractory angina that required revascularization. All data were analyzed according to the intention-to-treat principle. At a single institution, 611 patients were randomly assigned to CABG (n=203), PCI (n=205), or MT (n=203). The 10-year survival rates were 74.9% with CABG, 75.1% with PCI, and 69% with MT (P=0.089). The 10-year rates of myocardial infarction were 10.3% with CABG, 13.3% with PCI, and 20.7% with MT (P<0.010). The 10-year rates of additional revascularizations were 7.4% with CABG, 41.9% with PCI, and 39.4% with MT (P<0.001). Relative to the composite end point, Cox regression analysis showed a higher incidence of primary events in MT than in CABG (hazard ratio 2.35, 95% confidence interval 1.78 to 3.11) and in PCI than in CABG (hazard ratio 1.85, 95% confidence interval 1.39 to 2.47). Furthermore, 10-year rates of freedom from angina were 64% with CABG, 59% with PCI, and 43% with MT (P<0.001). CONCLUSIONS: Compared with CABG, MT was associated with a significantly higher incidence of subsequent myocardial infarction, a higher rate of additional revascularization, a higher incidence of cardiac death, and consequently a 2.29-fold increased risk of combined events. PCI was associated with an increased need for further revascularization, a higher incidence of myocardial infarction, and a 1.46-fold increased risk of combined events compared with CABG. Additionally, CABG was better than MT at eliminating anginal symptoms. Clinical Trial Registration Information- URL: http://www.controlled-trials.com. REGISTRATION NUMBER: ISRCTN66068876.

Asunto(s)

Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Vasodilatadores/uso terapéutico , Antagonistas Adrenérgicos beta/uso terapéutico , Anciano , Angioplastia Coronaria con Balón/mortalidad , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Puente de Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/cirugía , Supervivencia sin Enfermedad , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Índice de Severidad de la Enfermedad , Resultado del Tratamiento

RESUMEN

In the setting of percutaneous coronary intervention (PCI), due to a paucity of data, the optimal dose of aspirin isuncertain. We evaluated the safety of different doses of aspirin after PCI.Methods and results In the PCI-CURE study, 2658 patients with acute coronary syndromes undergoing PCI were stratified into three aspirin dose groups 200 mg (high, n » 1064), 101–199 mg (moderate, n » 538), and 100 mg (low, n » 1056). For efficacy, the moderate- (7.4%) and high-dose groups (8.6%) had similar rates of cardiovascular death, myocardialinfarction, or stroke compared with the low-dose group (7.1%). For safety, major bleeding was increased with highdose aspirin [3.9, 1.5, and 1.9% in the high-, moderate-, and low-dose groups; hazard ratio (HR) of high vs. low dose 2.05 (95% CI 1.20–3.50, P » 0.009]. The net adverse clinical events (death, MI, stroke, major bleeding) favoured low-over high-dose aspirin (8.4 vs. 11.0%, HR 1.31, 95% CI 1.00–1.73 P » 0.056). Conclusion In this large observational analysis of patients undergoing PCI, low-dose aspirin appeared to be as effective as higherdoses in preventing ischaemic events but was also associated with a lower rate of major bleeding and an improved net efficacy to safety balance.

Asunto(s)

Angioplastia Coronaria con Balón , Aspirina , Hemorragia , Infarto del Miocardio , Isquemia

RESUMEN

UNLABELLED: The MASS III Trial is a large project from a single institution, The Heart Institute of the University of Sao Paulo, Brazil (InCor), enrolling patients with coronary artery disease and preserved ventricular function. The aim of the MASS III Trial is to compare medical effectiveness, cerebral injury, quality of life, and the cost-effectiveness of coronary surgery with and without of cardiopulmonary bypass in patients with multivessel coronary disease referred for both strategies. The primary endpoint should be a composite of cardiovascular mortality, cerebrovascular accident, nonfatal myocardial infarction, and refractory angina requiring revascularization. The secondary end points in this trial include noncardiac mortality, presence and severity of angina, quality of life based on the SF-36 Questionnaire, and cost-effectiveness at discharge and at 5-year follow-up. In this scenario, we will analyze the cost of the initial procedure, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events during the follow-up. Exercise capacity will be assessed at 6-months, 12-months, and the end of follow-up. A neurocognitive evaluation will be assessed in a subset of subjects using the Brain Resource Center computerized neurocognitive battery. Furthermore, magnetic resonance imaging will be made to detect any cerebral injury before and after procedures in patients who undergo coronary artery surgery with and without cardiopulmonary bypass. TRIALS REGISTRATION: Clinical Trial registration information ISRCTN59539154 Off-pump vs. on-pump surgery in patients with Stable CAD MASS III.

RESUMEN

BACKGROUND: Despite routine use of coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI), no conclusive evidence exists that either modality is superior to medical therapy (MT) alone for treating multivessel coronary artery disease with stable angina and preserved ventricular function. METHODS AND RESULTS: The primary end points were total mortality, Q-wave myocardial infarction, or refractory angina requiring revascularization. The study comprised 611 patients randomly assigned to undergo CABG (n=203), PCI (n=205), or MT (n=203). At the 5-year follow-up, the primary end points occurred in 21.2% of patients who underwent CABG compared with 32.7% treated with PCI and 36% receiving MT alone (P=0.0026). No statistical differences were observed in overall mortality among the 3 groups. In addition, 9.4% of MT and 11.2% of PCI patients underwent repeat revascularization procedures compared with 3.9% of CABG patients (P=0.021). Moreover, 15.3%, 11.2%, and 8.3% of patients experienced nonfatal myocardial infarction in the MT, PCI, and CABG groups, respectively (P<0.001). The pairwise treatment comparisons of the primary end points showed no difference between PCI and MT (relative risk, 0.93; 95% confidence interval, 0.67 to 1.30) and a significant protective effect of CABG compared with MT (relative risk, 0.53; 95% confidence interval, 0.36 to 0.77). CONCLUSIONS: All 3 treatment regimens yielded comparable, relatively low rates of death. MT was associated with an incidence of long-term events and rate of additional revascularization similar to those for PCI. CABG was superior to MT in terms of the primary end points, reaching a significant 44% reduction in primary end points at the 5-year follow-up of patients with stable multivessel coronary artery disease.

Asunto(s)

Angioplastia Coronaria con Balón , Fármacos Cardiovasculares/uso terapéutico , Puente de Arteria Coronaria , Enfermedad Coronaria/terapia , Antagonistas Adrenérgicos beta/uso terapéutico , Anciano , Angina de Pecho/tratamiento farmacológico , Angina de Pecho/cirugía , Angina de Pecho/terapia , Angioplastia Coronaria con Balón/estadística & datos numéricos , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Puente de Arteria Coronaria/estadística & datos numéricos , Enfermedad Coronaria/dietoterapia , Enfermedad Coronaria/tratamiento farmacológico , Enfermedad Coronaria/mortalidad , Enfermedad Coronaria/cirugía , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/cirugía , Reestenosis Coronaria/terapia , Dieta con Restricción de Grasas , Supervivencia sin Enfermedad , Quimioterapia Combinada , Electrocardiografía , Determinación de Punto Final , Femenino , Estudios de Seguimiento , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , Infarto del Miocardio/prevención & control , Nitratos/uso terapéutico , Pronóstico , Reoperación , Stents , Análisis de Supervivencia , Resultado del Tratamiento