RESUMEN
PURPOSE: We assessed the feasibility of a large randomized trial intended to determine whether low-dose heparin prophylaxis given throughout hospitalization reduces mortality and morbidity in general medical patients. SUBJECTS AND METHODS: Hospitalized general medical patients aged more than 60 years at 5 Department of Veterans Affairs (VA) medical centers were randomized to receive enoxaparin 40 mg or identical placebo, given daily by subcutaneous injection until hospital discharge. Outcomes included total mortality at 90 days (the primary outcome) and 1 year, and occurrence in the VA hospital within 90 days of symptomatic deep venous thrombosis, pulmonary embolism, and major bleeding. RESULTS: Only 7.6% of hospitalized patients aged more than 60 years were eligible for the study, although a chart review had predicted 25%. The principal exclusions were prior indication for anticoagulation, anticipated need for anticoagulation, contraindication to heparin, expected hospitalization less than 3 days, and "supportive/palliative care only" status. We randomized 140 patients into each group, 28% of target recruitment. The groups were well matched by age and comorbidities. Death occurred in 13 patients receiving enoxaparin and 14 patients receiving placebo at 90 days (relative risk 0.93, 95% confidence interval 0.26-1.59), and in 36 and 32 patients, respectively, at 1 year (relative risk 1.13, 95% confidence interval 0.66-1.60). Clinical thromboembolic events occurred in 5 patients receiving enoxaparin and 8 patients receiving placebo, and major bleeding occurred in 2 and 5 patients, respectively. CONCLUSIONS: The pilot study indicated that the full study was not feasible. The decision to use prophylaxis pertains to only a small proportion of general medical patients hospitalized at VA medical centers, and this proportion is overestimated by chart review. The effect of low-dose heparin prophylaxis on clinical outcomes in hospitalized general medical patients remains uncertain.
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Anticoagulantes/administración & dosificación , Enoxaparina/administración & dosificación , Hospitalización , Tromboembolia/prevención & control , Anciano , Esquema de Medicación , Femenino , Humanos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Proyectos PilotoRESUMEN
BACKGROUND: The Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) study was a multicenter Veterans Affairs randomized trial and registry that compared long-term survival of percutaneous coronary intervention with coronary artery bypass graft surgery for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for an adverse outcome with bypass. Both the randomized trial and the registry demonstrated comparable 3-year survival. The purpose of this study was to compare bypass and percutaneous intervention survival of AWESOME patients who were older than 70 years of age. METHODS: Over a 5-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of the following five risk factors (prior heart surgery, myocardial infarction within 7 days, left ventricular ejection fraction less than 35%, age > 70 years, intraaortic balloon pump requirement to stabilize) were identified. Of these patients, 1,278 were older than 70 years of age. Eight hundred, seventy-one patients were turned down by at least one physician, 407 were acceptable to both physician and surgeon for randomization, and 236 (60%) consented to randomization. Of the 1,042 eligible patients who were not randomized, 871 had their revascularization directed by a physician who was not involved in the study. One hundred, seventy-one patients who were acceptable for randomization by both the interventional cardiologist and the cardiac surgeon refused consent. RESULTS: Bypass and percutaneous intervention survival were compared using Kaplan-Meier curves and log rank tests. Bypass and percutaneous intervention 36-month survival rates for patients older than 70 years of age were 76% and 75%, respectively, among the eligible patients. Survival was 71% and 78% among those patients who were randomized and 76% and 67% in the physician-directed subgroup. Of those patients who chose their revascularization techniques, the survivals were 79% and 85%, respectively. The survival differences are not large, and none of the global log rank tests of bypass compared with percutaneous intervention survival showed a statistically significant difference over 5 years. CONCLUSIONS: Both the randomized and registry subgroups of patients who were older than 70 years of age support the trial conclusions that either bypass or percutaneous intervention effectively relieves medically refractory ischemia among high-risk unstable angina patients whose age was greater than 70 years.
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Angina Inestable/terapia , Angioplastia Coronaria con Balón/estadística & datos numéricos , Puente de Arteria Coronaria/estadística & datos numéricos , Factores de Edad , Anciano , Angina Inestable/mortalidad , Angioplastia Coronaria con Balón/métodos , Angioplastia Coronaria con Balón/mortalidad , Estudios de Cohortes , Puente de Arteria Coronaria/métodos , Puente de Arteria Coronaria/mortalidad , Estudios de Seguimiento , Humanos , Evaluación de Procesos y Resultados en Atención de Salud , Selección de Paciente , Sistema de Registros , Factores de Riesgo , Análisis de Supervivencia , Resultado del Tratamiento , Estados Unidos/epidemiología , United States Department of Veterans AffairsRESUMEN
OBJECTIVE: The Veterans Affairs Cooperative Study in Diabetes Mellitus Type 2 Feasibility Trial (VA CSDM) studied standard and intensive glycemic treatment groups, achieving and maintaining for 27 months a difference in HbA1c of 2.1% (9.2% vs. 7.1%, respectively). A substudy planned in advance examined health status as assessed by a health status questionnaire obtained at baseline and 24 months. DESIGN AND METHODS: A randomized, prospective trial was carried out at five VA Medical Centers from 1990 to 1993. The sample involved 153 male veterans 40-69 years of age and with diabetes duration of 8+/-4 years, who were suboptimally controlled with standard glucose lowering treatment. The participants were randomized to intensive and standard treatment groups. In addition to a variety of indicators of glycemic control and complications, health-related qualify of life data were assessed using a 20-question version of the Medical Outcome Study instrument. Scores were evaluated at baseline and 24 months for changes between the treatment groups. RESULTS: The two groups were similar at baseline with respect to age, duration of diabetes, complications, comorbidities, and reported physical activity. The intensive treatment group had more frequent, mandatory self-glucose monitoring (vs. occasional measurement in the standard) and received two or more daily insulin injections (only one in the standard). This group had three times the number of clinic visits and 10-fold higher reported incidence of mild/moderate hypoglycemia. There were no significant changes in the health status over time in either the standard or intensive treatment groups, nor was there a difference between the two groups. CONCLUSIONS: Intensive glucose control in advanced Type 2 diabetes mellitus (DM) has no effect on health status over 2 years. The successful lowering of glycemia does not improve health-related quality of life nor do the increased demands of an intensive therapy regimen worsen it.
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Glucemia/efectos de los fármacos , Complicaciones de la Diabetes , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hemoglobina Glucada/efectos de los fármacos , Estado de Salud , Hipoglucemiantes/uso terapéutico , Calidad de Vida , Adulto , Anciano , Estudios de Factibilidad , Hemoglobina Glucada/metabolismo , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
OBJECTIVE: The Veterans Affairs Diabetes Trial (VADT) cohort is enriched with approximately 20% Hispanics and 20% African Americans, affording a unique opportunity to study ethnic differences in retinopathy. RESEARCH DESIGN AND METHODS: Cross-sectional analyses on the baseline seven-field stereo fundus photos of 1,283 patients are reported here. Diabetic retinopathy scores are grouped into four classes of increasing severity: none (10-14), minimal nonproliferative diabetic retinopathy (NPDR) (15-39), moderate to severe NPDR (40-59), and proliferative diabetic retinopathy (60+). These four groups have also been dichotomized to none or minimal (10-39) and moderate to severe diabetic retinopathy (40+). RESULTS: The prevalence of diabetic retinopathy scores >40 was higher for Hispanics (36%) and African Americans (29%) than for non-Hispanic whites (22%). The difference between Hispanics and non-Hispanic whites was significant (P < 0.05). Similarly, the prevalence of diabetic retinopathy scores >40 was significantly higher in African Americans than in non-Hispanic whites (P < 0.05). These differences could not be accounted for by an imbalance in traditional risk factors such as age, duration of diagnosed diabetes, HbA(1c) (A1C), and blood pressure. Diabetic retinopathy severity scores were also significantly associated with increasing years of disease duration, A1C, systolic and diastolic blood pressure, the degree of microalbuminuria, fibrinogen, and the percentage of patients with amputations. There was no relationship between retinopathy severity and the percentage of people who had strokes or cardiac revascularization procedures. There was an inverse relationship between retinopathy severity and total cholesterol, triglycerides, and plasminogen activator inhibitor-1 as well as with smoking history. Diabetic retinopathy scores were not associated with age. CONCLUSIONS: In addition to many well-known associations with retinopathy, a higher frequency of severe diabetic retinopathy was found in the Hispanic and African-American patients at entry into the VADT that is not accounted for by traditional risk factors for diabetic retinopathy, and these substantial ethnic differences remain to be explained.
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Retinopatía Diabética/epidemiología , Etnicidad , Grupos Raciales , Veteranos , Adulto , Negro o Afroamericano , Glucemia/análisis , Presión Sanguínea , Colesterol/sangre , Retinopatía Diabética/sangre , Hemoglobina Glucada/análisis , Hispánicos o Latinos , Humanos , Persona de Mediana Edad , Factores de Riesgo , Triglicéridos/sangre , Estados UnidosRESUMEN
This retrospective observational review compares patient characteristics and in-hospital and long-term outcomes of cohorts of patients undergoing percutaneous coronary intervention (PCI) for cardiogenic shock complicating acute myocardial infarction (MI) prior to the use of stents (as well as glycoprotein IIb/IIIa inhibitor and dual-antiplatelet therapy) with PCI in the stent era. Cardiogenic shock remains the leading cause of hospital mortality from acute MI. This is a report of consecutive patients with cardiogenic shock complicating acute MI, without mechanical complication, referred for emergency catheterization to a single operator at two consecutive Veterans Affairs medical centers over a 15-year period (1988 to August 2003). PCI was attempted in all 93 cases: 44 consecutive patients in the present era and 49 consecutive patients in the stent era. Patients with comparable extent of coronary disease, more ST elevation myocardial infarction, multiple areas of infarction, and greater comorbidity underwent PCI in the stent era. Nevertheless, PCI in the stent era was associated with higher rates of acute success and improved in-hospital survival. Kaplan-Meier curves and log-rank testing showed highly significant improvement in overall survival (P < 0.0001). Logistic regression of in-hospital survival demonstrated that stent use (colinear with glycoprotein IIb/IIIa use and dual-antiplatelet therapy) was significantly associated with survival in a model adjusting for extent of coronary disease and comorbidities (P = 0.007). Stents and abciximab have been associated with improved acute angiographic and procedural success of PCI for cardiogenic shock, leading to improved survival.
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Angioplastia Coronaria con Balón/métodos , Anticuerpos Monoclonales/uso terapéutico , Implantación de Prótesis Vascular/instrumentación , Materiales Biocompatibles Revestidos , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Choque Cardiogénico/mortalidad , Stents , Abciximab , Anciano , Angiografía Coronaria , Electrocardiografía , Femenino , Estudios de Seguimiento , Mortalidad Hospitalaria/tendencias , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/complicaciones , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Observación , Estudios Retrospectivos , Choque Cardiogénico/etiología , Choque Cardiogénico/terapia , Tasa de Supervivencia/tendencias , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
The recently concluded Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) was a randomized clinical trial of percutaneous coronary intervention versus coronary bypass graft surgery among patients with medically refractory ischemia who were at high risk for coronary bypass graft surgery because of > or =1 risk factors that included severely reduced left ventricular (LV) function, defined as LV ejection fraction <35%. This study reports the outcome of patients with LV ejection fraction <35% in the randomized clinical trial and the physician-directed and patient choice registries of the AWESOME study.
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Angina de Pecho/terapia , Angioplastia Coronaria con Balón , Gasto Cardíaco Bajo/terapia , Puente de Arteria Coronaria , Anciano , Angina de Pecho/mortalidad , Angina de Pecho/patología , Gasto Cardíaco Bajo/mortalidad , Gasto Cardíaco Bajo/patología , Femenino , Humanos , Masculino , Estudios Prospectivos , Sistema de Registros , Análisis de Supervivencia , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVE: To compare lifestyle factors, cardiovascular risk factors, and coronary artery calcium (CAC) and abdominal aortic calcium (AAC) levels in Hispanic and non-Hispanic white (NHW) individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: We recently demonstrated in a small group of nonreferred, healthy, nondiabetic subjects that CAC was reduced in Hispanics compared with NHWs, despite a worse cardiovascular risk factor profile. In this study, we evaluated whether this ethnic disparity in vascular calcification was present in individuals with type 2 diabetes and in several different arterial beds. Hispanic and NHW subjects (n = 245) with type 2 diabetes were evaluated for cardiovascular risk factors using questionnaires and assays of plasma biomarkers. CAC and AAC were measured by electron-beam computer-assisted tomography. RESULTS: Although Hispanics were slightly younger than NHWs, other standard risk factors and novel cardiovascular risk factors, including plasminogen activator-1 and fibrinogen levels, were similar between the groups. Despite the similar risk factor profile, the prevalence of cardiovascular disease (CVD) and mean and median levels of CAC and AAC were lower in Hispanics. Furthermore, the distribution of these calcium scores differed from that of NHWs (P < 0.05), with significantly fewer Hispanic subjects having high CAC or AAC scores. These differences were not explained by differences in CVD prevalence or any measured lifestyle or risk factor. CONCLUSIONS: Hispanics with type 2 diabetes have reduced CAC and AAC levels compared with NHW subjects, suggesting a reduction in the overall burden of vascular calcification and atherosclerosis. These data are consistent with the notion that Hispanics are protected against the development of CVD.
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Aorta Abdominal , Calcinosis/epidemiología , Vasos Coronarios , Diabetes Mellitus Tipo 2/fisiopatología , Angiopatías Diabéticas/epidemiología , Etnicidad , Hispánicos o Latinos , Humanos , Persona de Mediana Edad , Factores de Riesgo , FumarRESUMEN
OBJECTIVES: We compared six-month health-related quality of life (HRQL) for high-risk patients with medically refractory ischemia randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery. BACKGROUND: Mortality rates after PCI and CABG surgery are similar. Therefore, differences in HRQL outcomes may help in the selection of a revascularization procedure. METHODS: Patients were enrolled in a Veterans Affairs multicenter randomized trial comparing PCI versus CABG for patients with medically refractory ischemia and one or more risk factors for adverse outcome; 389 of 423 patients (92%) alive six months after randomization completed an Short Form-36 (SF-36) health status survey. Primary outcomes were the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36. Multivariable analyses were used to evaluate whether PCI or CABG surgery was associated with better PCS or MCS scores after adjusting for over 20 baseline variables. RESULTS: There were no significant differences in either PCS scores (38.7 vs. 37.3 for PCI and CABG, respectively; p = 0.23) or MCS scores (45.5 vs. 46.1, p = 0.58) between the treatment arms. In multivariable models, there remained no difference in HRQL for post-PCI versus post-CABG patients (for PCS, absolute difference = 0.56 +/- standard error of 1.14, p = 0.63; for MCS, absolute difference = -1.23 +/- 1.12, p = 0.27). We had 97% power to detect a four-point difference in scores, where four to seven points is a clinically important difference. CONCLUSIONS: High-risk patients with medically refractory ischemia randomized to PCI versus CABG surgery have equivalent six-month HRQL. Therefore, HRQL concerns should not drive decision-making regarding selection of a revascularization procedure for these patients.
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Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Isquemia Miocárdica/terapia , Calidad de Vida , Anciano , Femenino , Estado de Salud , Humanos , Masculino , Salud Mental , Persona de Mediana Edad , Análisis Multivariante , Factores de Riesgo , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
BACKGROUND/OBJECTIVES: High urethral resistance or detrusor-sphincter dyssynergia (DSD) is characterized by obstructed voiding during bladder contractions. DSD is caused by an exaggerated pelvic floor reflex resulting from sensory input from elevated pressure in the bladder that produces reflex constriction of the urethral sphincter. The objective of this study was to determine whether sensory input from the bladder produced synergistic or dyssynergic pelvic floor reflexes following SCI in an animal model. METHODS: A pelvic floor reflex that shares the same motor pathway with DSD is the bulbocavernosus (BC) reflex. The BC reflex was elicited with electrical stimulation in 4 male cats with T1 spinal injury, and recorded as an anal sphincter contraction. Recordings were obtained during control and elevated bladder pressures. Increased bladder pressure was induced with either manual pressure (Crede procedure) or spontaneous contractions resulting from bladder filling. RESULTS: During the control period, the BC reflex indicated by the peak anal pressure response was 23 +/- 6 cmH2O. During elevated bladder pressure of 34 +/- 18 cmH2O, the BC response decreased to 10 +/- 3 cmH2O (not significant), showing a synergistic relationship. Anal sphincter tone between BC reflex tests showed a dyssynergic response. All 4 animals showed increased tone during elevated bladder pressures that averaged 9 +/- 5 cmH2O. Because abdominal pressure was not recorded, the significance is not clear. However, there was further support of a dyssynergic relationship based on increases in the anal and urethral electromyography recordings and some pelvic floor spasms during the elevated bladder pressure. CONCLUSIONS: Because 2 different pelvic floor activities were observed during increased bladder pressures, this animal model may be described best as a mixed model. This model shows both synergistic and dyssynergic relationships between the bladder and the BC contractions. Although observed changes were not significant, the unique observations of synergistic bladder-sphincter activity shown by the inhibited BC reflex is in marked contrast to the strictly dyssynergic bladder-sphincter relationship seen in SCI patients.
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Canal Anal/inervación , Neuronas Motoras/fisiología , Hipertonía Muscular/fisiopatología , Diafragma Pélvico/inervación , Reflejo Anormal/fisiología , Traumatismos de la Médula Espinal/fisiopatología , Uretra/inervación , Vejiga Urinaria Neurogénica/fisiopatología , Urodinámica/fisiología , Animales , Gatos , Presión Hidrostática , Contracción Isométrica/fisiología , Masculino , Inhibición Neural/fisiología , Vejiga Urinaria/inervaciónRESUMEN
OBJECTIVES: This report compares long-term percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) survival among post-CABG patients included in the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial and prospective registry. BACKGROUND: Repeat CABG surgery is associated with a higher risk of mortality than first-time CABG. The AWESOME is the first randomized trial comparing CABG with PCI to include post-CABG patients. METHODS: Over a five-year period (1995 to 2000), patients at 16 hospitals were screened to identify a cohort of 2,431 individuals who had medically refractory myocardial ischemia and at least one of five high-risk factors. There were 454 patients in the randomized trial, of whom 142 had prior CABG. In the physician-directed registry of 1,650 patients, 719 had prior CABG. Of the 327 patient-choice registry patients, 119 had at least one prior CABG. The CABG and PCI survivals for the three groups were compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI three-year survival rates were 73% and 76% respectively for the 142 randomized patients (75 and 67 patients) (log-rank = NS). In the physician-directed registry, 155 patients were assigned to reoperation and 357 to PCI (207 received medical therapy); 36-month survivals were 71% and 77% respectively (log-rank = NS). In the patient-choice registry, 32 patients chose reoperation and 74 chose PCI (13 received medical therapy); 36-month survivals were 65% and 86% respectively (log-rank test p = 0.01). CONCLUSIONS: Percutaneous coronary intervention is preferable to CABG for many post-CABG patients.
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Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Isquemia Miocárdica/terapia , Anciano , Toma de Decisiones , Supervivencia sin Enfermedad , Humanos , Isquemia Miocárdica/epidemiología , Estudios Prospectivos , Recurrencia , Sistema de Registros , Factores de Riesgo , Volumen Sistólico/fisiología , Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVES: This study compared survival after percutaneous coronary intervention (PCI) with survival after coronary artery bypass graft surgery (CABG) among diabetics in the Veterans Affairs AWESOME (Angina With Extremely Serious Operative Mortality Evaluation) study randomized trial and registry of high-risk patients. BACKGROUND: Previous studies indicate that CABG may be superior to PCI for diabetics, but no comparisons have been made for diabetics at high risk for surgery. METHODS: Over five years (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior CABG, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, or an intra-aortic balloon being required to stabilize) were identified. A total of 781 were acceptable for CABG and PCI, and 454 consented to be randomized. The 1,650 patients not acceptable for both CABG and PCI constitute the physician-directed registry, and the 327 who were acceptable but refused to be randomized constitute the patient-choice registry. Diabetes prevalence was 32% (144) among randomized patients, 27% (89) in the patient-choice registry, and 32% (525) in the physician-directed registry. The CABG and PCI survival rates were compared using Kaplan-Meier curves and log-rank tests. RESULTS: The respective CABG and PCI 36-month survival rates for diabetic patients were 72% and 81% for randomized patients, 85% and 89% for patient-choice registry patients, and 73% and 71% for the physician-directed registry patients. None of the differences was statistically significant. CONCLUSIONS: We conclude that PCI is a relatively safe alternative to CABG for diabetic patients with medically refractory unstable angina who are at high risk for CABG.
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Angina Inestable/terapia , Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Complicaciones de la Diabetes , Anciano , Angina Inestable/complicaciones , Angina Inestable/mortalidad , Diabetes Mellitus/mortalidad , Supervivencia sin Enfermedad , Humanos , Selección de Paciente , Estudios Prospectivos , Sistema de Registros , Factores de Riesgo , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
An interactive data management (IDM) system for the Spinal Cord Injury (SCI) Service was developed to collect self-reported patient data related to secondary medical complications and to provide feedback to the SCI rehabilitation team. The long-term objective is to improve clinical care through a process of staff review of current rehabilitation programs in the areas of prevalence, prevention, and management. Based on data from the first 99 SCI patients visiting the clinic and hospital after the installation of the IDM system, SCI patients reported high rates of current problems with spasticity (53 percent), pain (44 percent), and pressure ulcers (38 percent). Respiratory (12 percent) and bowel (14 percent) problems were less common current problems. The SCI staff questioned the reportedly high spasticity rates. They thought that the patients' answers might have indicated simply the occurrence of spasticity, rather than the more important issue of severe spasticity that interferes with daily activities. The staff suggested several additional spasticity questions to add to the study. In other areas, only a small percentage of patients wanted to talk with a therapist about prevention of pressure ulcers. Patients who had urinary problems consistently reported five urinary signs (e.g., cloudy urine). The clinical staff found these data informative and stated that they should continue to be collected.
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Espasticidad Muscular/etiología , Dolor/etiología , Úlcera por Presión/etiología , Traumatismos de la Médula Espinal/complicaciones , Traumatismos de la Médula Espinal/rehabilitación , Infecciones Urinarias/etiología , Adulto , Distribución de Chi-Cuadrado , Bases de Datos Factuales , Hospitales de Veteranos , Humanos , Incidencia , Puntaje de Gravedad del Traumatismo , Masculino , Persona de Mediana Edad , Espasticidad Muscular/epidemiología , Dolor/epidemiología , Participación del Paciente , Úlcera por Presión/epidemiología , Probabilidad , Medición de Riesgo , Autocuidado , Alienación Social , Infecciones Urinarias/epidemiologíaRESUMEN
OBJECTIVES: This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results. BACKGROUND: The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival. METHODS: Over a five-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI 36-month survival rates for randomized patients were 79% and 80%, respectively. The CABG and PCI 36-month survival rates were both 76% for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80% and 89%, respectively. None of the global log-rank tests for survival demonstrated significant differences. CONCLUSIONS: Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.