Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial.

CONTEXT: Sodium bicarbonate has been suggested as a possible strategy for prevention of contrast medium-induced nephropathy, a common cause of renal failure associated with prolonged hospitalization, increased health care costs, and substantial morbidity and mortality. OBJECTIVE: To determine if sodium bicarbonate is superior to sodium chloride for preventing contrast medium-induced nephropathy in patients with moderate to severe chronic kidney dysfunction who are undergoing coronary angiography. DESIGN, SETTING, AND PATIENTS: Randomized, controlled, single-blind study conducted between January 2, 2006, and January 31, 2007, and enrolling 353 patients with stable renal disease who were undergoing coronary angiography at a single US center. Included patients were 18 years or older and had an estimated glomerular filtration rate of 60 mL/min per 1.73 m(2) or less and 1 or more of diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years. INTERVENTIONS: Patients were randomized to receive either sodium chloride (n = 178) or sodium bicarbonate (n = 175) administered at the same rate (3 mL/kg for 1 hour before coronary angiography, decreased to 1.5 mL/kg per hour during the procedure and for 4 hours after the completion of the procedure). MAIN OUTCOME MEASURE: The primary end point was a 25% or greater decrease in the estimated glomerular filtration rate on days 1 through 4 after contrast exposure. RESULTS: Median patient age was 71 (interquartile range, 65-76) years, and 45% had diabetes mellitus. The groups were well matched for baseline characteristics. The primary end point was met in 13.3% of the sodium bicarbonate group and 14.6% of the sodium chloride group (relative risk, 0.94; 95% confidence interval, 0.55-1.60; P = .82). In patients randomized to receive sodium bicarbonate vs sodium chloride, the rates of death, dialysis, myocardial infarction, and cerebrovascular events did not differ significantly at 30 days (1.7% vs 1.7%, 0.6% vs 1.1%, 0.6% vs 0%, and 0% vs 2.2%, respectively) or at 30 days to 6 months (0.6% vs 2.3%, 0.6% vs 1.1%, 0.6% vs 2.3%, and 0.6% vs 1.7%, respectively) (P > .10 for all). CONCLUSION: The results of this study do not suggest that hydration with sodium bicarbonate is superior to hydration with sodium chloride for the prevention of contrast medium-induced nephropathy in patients with moderate to severe chronic kidney disease who are undergoing coronary angiography. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00312117.

Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions.

OBJECTIVES: The purpose of this study was to determine whether long-term clinical outcomes differed between bare-metal stents (BMS) and drug-eluting stents (DES) by duration of clopidogrel use among diabetic patients. BACKGROUND: There is concern that DES are associated with late adverse events such as death and myocardial infarction (MI) secondary to stent thrombosis. However, data on outcomes in diabetic patients remain limited. METHODS: We identified 749 patients with diabetes mellitus who underwent stent implantation with either BMS (n = 251) or DES (n = 498) from October 2002 to December 2004. We performed survival analysis on the full cohort and on those event-free from death, MI, or repeat revascularization at 6 months (n = 671). RESULTS: By clopidogrel duration, the event rate for death or MI was 3.2% in the >9-month group, 9.4% in the 6- to 9-month group, and 16.5% in the <6-month group, p < 0.001. For death alone, the event rate was 0.5% in the >9-month group, 4.3% in the 6- to 9-month group, and 10.0% in the <6-month group, p < 0.001. When taking BMS clopidogrel non-users as a referent in the multivariate analysis, the hazard ratio (95% confidence interval [CI]) for death and nonfatal MI for DES clopidogrel users, DES clopidogrel nonusers, and BMS clopidogrel users were: HR 0.22 (95% CI 0.08 to 0.62, p = 0.005), HR 0.39 (95% CI 0.13 to 1.13, p = 0.08), and HR 0.25 (95% CI 0.08 to 0.81, p = 0.02), respectively. CONCLUSIONS: Longer duration of clopidogrel use was associated with a lower incidence of death or MI in both the BMS and DES groups. Among clopidogrel nonusers, the incidence of death/MI or death did not differ by stent type.

Sacral neuromodulation: cost considerations and clinical benefits.

OBJECTIVES: To demonstrate the efficacy of sacral neuromodulation and compare voiding-related health care utilization costs before and after receiving an implant. METHODS: A retrospective review of patients receiving InterStim therapy (Medtronic Neurological, Minneapolis, Minn) was completed. Health care utilization was determined for the year before and the year after implantation, and included hospital and clinic visits, diagnostic and therapeutic procedures, and prescriptions. Utilization costs were derived from Medicare CPT coding and reimbursement data. Drug costs were derived from the actual pharmacy costs. Efficacy was assessed subjectively by patient-reported questionnaire and objectively by voiding diary, pad usage, and number of catheterizations. RESULTS: Sixty-five patients received InterStim therapy. Outpatient visits for urinary symptoms decreased in the 12 months after implantation with a mean decrease of 2.2 visits (P <0.0001). This resulted in a 73% reduction in average yearly office visit expenses from $994 to $265 per patient. After implant, diagnostic and therapeutic procedures performed decreased by 0.97 (P <0.0001). This translated into a decrease in the cost of therapeutic and diagnostic procedures from $733 to $59 per patient (P <0.0001). Drug costs were significantly decreased (P <0.02) from $693 to $483 per patient. These cost savings represent a 92% reduction in outpatient doctor visits and diagnostic and procedure costs along with and a 30% reduction in drug expenditures. CONCLUSION: After InterStim therapy, voiding-related health care costs are reduced. InterStim therapy is an effective treatment option with high patient satisfaction for medically refractory voiding dysfunction.