Treatment with everolimus is associated with a procoagulant state.
Baas MC, Gerdes VE, et al.Thrombosis Research 2013; 132 (2): 307–311
Aims
To investigate whether mammalian target of rapamycin inhibitor (mTORi) everolimus (EVR) leads to a procoagulant state in renal transplant recipients, compared with recipients on a calcineurin inhibitor (CNI) and/or mycophenolate sodium (MPS) regimen.
Interventions
Patients were treated with either EVR or CNI and/ or MPS.
Participants
36 first or second renal transplant recipients.
Outcomes
The primary outcome was interstitial graft fibrosis and hylinosis. The secondary outcome was graft rejection.
Follow-up
6 months.
CET Conclusions
This is an interesting study from a single centre using patients nested in a multicentre randomised trial. The authors found an increased procoagulant state in renal transplant recipients treated with the mTORi (everolimus) compared to those treated with a CNI and/or MPS. There appeared to be increased endothelial cell activation, thrombin formation and impaired fibrinolysis which would suggest an increased risk of thrombotic events in renal transplant recipients treated with mTOR inhibitors. The authors flag this as a warning and the need for a prospective study to establish the precise risk of thrombotic events in patients on mTOR inhibitors.
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed in Bemelman FJ et al. Minimization of maintenance immunosuppression early after renal transplantation: an interim analysis. Transplantation 2009; 88: 421-8.
Trial registration
Dutch trial registry NTR567 and ISRCTN Register number - ISRCTN69188731