RESUMEN
BACKGROUND: Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. METHODS: We randomly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. Primary end points were the rate of death and a composite of death, myocardial infarction, or stroke (major cardiovascular events). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. RESULTS: At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%, P=0.97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%, P=0.89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P=0.70) and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P=0.13). In the PCI stratum, there was no significant difference in primary end points between the revascularization group and the medical-therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical-therapy group (30.5%, P=0.01; P=0.002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%, P=0.003). CONCLUSIONS: Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision. (ClinicalTrials.gov number, NCT00006305.)
Asunto(s)
Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Enfermedad Coronaria/terapia , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Terapia Combinada , Angiografía Coronaria , Enfermedad Coronaria/complicaciones , Enfermedad Coronaria/cirugía , Diabetes Mellitus Tipo 2/complicaciones , Femenino , Hemoglobina Glucada , Humanos , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Estimación de Kaplan-Meier , Masculino , Metformina/uso terapéutico , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Infarto del Miocardio/prevención & control , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , Compuestos de Sulfonilurea/uso terapéutico , Tiazolidinedionas/uso terapéuticoRESUMEN
OBJECTIVE: To explore the relationship between gender, native artery diameters, and outcomes of stent revascularization (ST) in the "Claudication: Exercise versus Endoluminal Revascularization" trial. METHODS: A comparative analysis was performed of the impact of gender, age, weight, height, body mass index, and body surface area on revascularization outcomes at baseline and 6months in 55 arterial segments of aorta, common iliac artery, and external iliac artery (EIA). RESULTS: Women demonstrated smaller diameter of the EIA. However, the clinical outcomes of revascularization were not negatively affected by the gender-based differences. CONCLUSION: Gender-based differences are unlikely to significantly impact outcome of ST.