Aspirin Use and Incident Cardiovascular Disease, Kidney Failure, and Death in Stable Kidney Transplant Recipients: A Post Hoc Analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial.
Dad T, Tighiouart H, et al.American Journal of Kidney Diseases 2016; 68(2): 277-286.
Aims
To examine whether reported aspirin use is associated with a reduction in cardiovascular disease (CVD) events, kidney failure, or allcause mortality among participants without a history of CVD.
Interventions
This was a post hoc analysis of the FAVORIT* trial where participants were randomly assigned to treatment with either a multivitamin that included a high dose or a low dose of folic acid, vitamin B6, and vitamin B12. A propensity score was used to match participants who reported aspirin use at baseline with those who did not to evaluate the effect of aspirin use on study outcomes.
Participants
3,122 stable kidney transplant recipients aged 35-75 years from the FAVORIT trial who had a kidney transplant for at least 6 months and no known history of CVD.
Outcomes
The primary outcomes measured were CVD events, kidney failure, allcause mortality, a composite of CVD events or all-cause death, and a composite of kidney failure or all-cause mortality.
Follow-up
Mean follow-up of 4 years
CET Conclusions
This is a post-hoc cohort analysis of the FAVORIT trial which studied the effect of homocysteine-lowering vitamins on cardiovascular disease (CVD) in stable kidney transplant recipients. The aim of the post-hoc analysis was to investigate whether aspirin use in study participants without a history of CVD was associated with a lower rate of CVD events, kidney failure or all-cause mortality. Of the 4,110 participants originally randomised 2,677 participants had complete data. When missing data for 445 patients were imputed the total data set came to 3,122. Propensity score matching was used to account for differences in baseline covariates between aspirin users and nonusers and 981 aspirin users were matched to 981 nonusers. Use of aspirin was self-reported and defined as use of aspirin at least once a week for several months prior to randomization. All events were monitored during a mean follow-up of 4 years. Adjusted models comparing aspirin users with nonusers showed no difference in incident CVD events, all-cause mortality or kidney failure.
Data analysis
Per protocol analysis
Quality notes
Previously assessed as *Bostom AG, et al. Homocysteine lowering and cardiovascular disease outcomes in kidney transplant recipients. Circulation. 2011;123:1763-1770.
Trial registration
ClinicalTrials.gov - NCT00064753