Outcomes in ethnic minority renal transplant recipients receiving everolimus versus mycophenolate: comparative risk assessment results from a pooled analysis.

BACKGROUND: Everolimus (EVR) has demonstrated good efficacy after renal transplantation. Racial disparities in clinical outcomes after de novo renal transplantation are well documented; whether the efficacy of EVR varies based on recipient ethnicity is unknown. We conducted a comparative risk assessment of EVR by ethnicity. METHODS: Data on 2004 renal transplant recipients from three EVR studies were pooled to identify the impact of ethnicity on efficacy outcomes across EVR dosing groups and control groups. Ethnic groups compared were African Americans, non-U.S. blacks, Asians, Hispanics, and Caucasians. EVR groups received either 1.5 or 3 mg per day, with either standard-dose cyclosporine or reduced-dose cyclosporine. Control groups received mycophenolic acid (MPA) with standard-dose cyclosporine. Composite efficacy failure endpoint was graft loss, death, biopsy-proven acute rejection, or lost to follow-up. Adjusted odds ratios were calculated using a logistic regression model. RESULTS: The proportion of renal transplant recipients who met the composite endpoint was African Americans (46%), non-U.S. black (35%), Caucasian (31%), Hispanic (28%), and Asian (25%). The odds of meeting the composite endpoint were significantly (P=0.0001) greater for African Americans versus Caucasians but did not differ among the other ethnic groups (ethnic groups were only compared with Caucasians). EVR and MPA were associated with similar efficacy among each of the ethnic groups. CONCLUSION: In this pooled data analysis in more than 2000 renal transplant recipients, EVR versus MPA resulted in similar composite endpoint incidence events across ethnicities. Consistent with previously published data, African Americans had poorer clinical outcomes. EVR is efficacious regardless of ethnicity.

Urinary tract infection associated with ureteral stents in renal transplantation.

OBJECTIVES: In the mid 1980s, ureteral stents were used in renal transplantation when ureteral injury had occurred. Subsequently, it was shown that routine ureteral stent placement at the time of transplantation reduced urological complications. We carried out a chart review on renal transplant patients and noted which patients developed urinary tract infections (UTIs) with stents in place, and whether these infections ultimately affected transplant outcome. We sought to distinguish subgroups of patients who were more likely to develop infection and to identify the optimum time for stent removal. PATIENTS AND METHODS: We performed a retrospective chart review of 213 patients who underwent renal transplantation in 1994 and 1995. Adequate follow-up information was available on 167 patients with intraoperative stent placement. Of these 167 patients, 4 patients expired and 8 required transplant nephrectomy due to complications unrelated to the stent. RESULTS: In total, 35 patients (22.6%) developed a post-operative UTI. One infection occurred during the first week following transplant, 3 developed within 2 weeks, and importantly, the remaining 32 infections occurred more than 2 weeks after transplant. An increase in infections in diabetics (25.7%) as compared to other transplant recipients (20.2%) was noted. Patients with cadaveric renal transplants are also at higher risk of UTI (24%) compared to those with living related donors (15%). CONCLUSION: The use of ureteral stents is safe, but is associated with a UTI rate of 22.6%. To reduce infection rates, we recommend stent removal within 14 days and earlier if possible, particularly in diabetic patients who have received a cadaveric renal transplant.