Kidney Function and Risk of Cardiovascular Disease and Mortality in Kidney Transplant Recipients: The FAVORIT Trial.
Weiner DE, Carpenter MA, et al.American Journal of Transplantation 2012; 12(9): 2437-2445.
Aims
To explore risk factors for cardiovascular disease (CVD) and all-cause mortality in kidney transplant recipients.
Interventions
Standard multivitamin with high doses of folic acid (5 mg), vitamin B6 (pyridoxine 50 mg) and vitamin B12 (cyanocobalamin 1 mg) versus a multivitamin containing low doses of vitamin B6 (1.4 mg) and vitamin B12 (2 µg) with no folic acid.
Participants
4016 stable kidney transplant recipients.
Outcomes
The primary CVD outcome was a composite of CVD death, myocardial infarction, resuscitated sudden death, stroke, coronary revascularization, peripheral, carotid, aortic or renal artery procedures. The secondary outcome was all-cause mortality. The variables included in the regression model were serum creatinine and eGFR, patients’ baseline characteristics (age, sex, race, country of origin), smoking status, past medical history (baseline CVD, diabetes mellitus), transplant characteristics (living donor kidney, time since transplant), physical examination findings (body mass index, systolic an
Follow-up
Median of 3.8 years
CET Conclusions
In this post hoc study of the FAVORIT trial to assess risk factors for cardiovascular disease and mortality in kidney transplant recipients they have evaluated the association between GFR and subsequent events, particularly cardiovascular disease. The result suggests that in stable kidney transplant recipients a low GFR is independently associated with adverse events, in particular cardiovascular disease, which may result from the reduced kidney function rather than pre existing comorbidity.
Data analysis
Per protocol analysis
Quality notes
The quality assessment is based on a previous report of the same trial: “Bostom AG, Carpenter MA, et al. Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients: Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial. Circulation, 123(16): 1763-1770, 2011â€.
Trial registration
NCT00064753 (ClinicalTrials.gov)