(140) - Correlation Between Lipid Levels and Cardiovascular Events in Heart Transplant Recipients: 24-Month Analysis of the A2310 Study

Abstract

PurposeCardiovascular disease is one of the major causes of death among the heart transplant recipients (HTxR). Data from A2310 study showed that treatment with everolimus (EVR) prevents cardiac allograft vasculopathy regardless of increased lipid levels in HTxR. This retrospective analysis of A2310 data assesses the correlation between increased lipid levels and the reported adverse cardiovascular events (CVE) in HTxR receiving EVR+ cyclosporine (CsA) or mycophenolate mofetil (MMF)+CsA.MethodsA2310, a 24-month, open-label, multi-centre study (NCT00300274) with 721 HTx recipients randomised to either EVR 1.5mg (N=282) or EVR 3.0mg (N=168), each dose with reduced CsA or MMF 3.0g (N=271) + standard CsA; with steroids ± induction. CVE assessment included adverse events related to ischaemic heart disease, cerebrovascular disorders, and arterial embolic/thrombotic events, and complete lipid panel was assessed at all visits.ResultsComparison is presented only for EVR 1.5 mg vs MMF groups, since EVR 3.0 mg arm was terminated early due to higher mortality. At Month 24, comparable proportion of patients in both EVR and MMF groups (25.8% vs. 25.4%) experienced CVE. The recipients in the MMF group with CVE had higher mean lipid levels (except for HDL), while this correlation was not observed in the EVR group with CVE (Table). Further, the rate of statins usage in recipients of EVR group (88.8%) was lower compared to the MMF group (98.5%) with CVE at Month 24.ConclusionElevated lipid levels in patients treated with EVR+rCsA were not associated with an increase in the incidence of CVE at two years after HTx. PurposeCardiovascular disease is one of the major causes of death among the heart transplant recipients (HTxR). Data from A2310 study showed that treatment with everolimus (EVR) prevents cardiac allograft vasculopathy regardless of increased lipid levels in HTxR. This retrospective analysis of A2310 data assesses the correlation between increased lipid levels and the reported adverse cardiovascular events (CVE) in HTxR receiving EVR+ cyclosporine (CsA) or mycophenolate mofetil (MMF)+CsA. Cardiovascular disease is one of the major causes of death among the heart transplant recipients (HTxR). Data from A2310 study showed that treatment with everolimus (EVR) prevents cardiac allograft vasculopathy regardless of increased lipid levels in HTxR. This retrospective analysis of A2310 data assesses the correlation between increased lipid levels and the reported adverse cardiovascular events (CVE) in HTxR receiving EVR+ cyclosporine (CsA) or mycophenolate mofetil (MMF)+CsA. MethodsA2310, a 24-month, open-label, multi-centre study (NCT00300274) with 721 HTx recipients randomised to either EVR 1.5mg (N=282) or EVR 3.0mg (N=168), each dose with reduced CsA or MMF 3.0g (N=271) + standard CsA; with steroids ± induction. CVE assessment included adverse events related to ischaemic heart disease, cerebrovascular disorders, and arterial embolic/thrombotic events, and complete lipid panel was assessed at all visits. A2310, a 24-month, open-label, multi-centre study (NCT00300274) with 721 HTx recipients randomised to either EVR 1.5mg (N=282) or EVR 3.0mg (N=168), each dose with reduced CsA or MMF 3.0g (N=271) + standard CsA; with steroids ± induction. CVE assessment included adverse events related to ischaemic heart disease, cerebrovascular disorders, and arterial embolic/thrombotic events, and complete lipid panel was assessed at all visits. ResultsComparison is presented only for EVR 1.5 mg vs MMF groups, since EVR 3.0 mg arm was terminated early due to higher mortality. At Month 24, comparable proportion of patients in both EVR and MMF groups (25.8% vs. 25.4%) experienced CVE. The recipients in the MMF group with CVE had higher mean lipid levels (except for HDL), while this correlation was not observed in the EVR group with CVE (Table). Further, the rate of statins usage in recipients of EVR group (88.8%) was lower compared to the MMF group (98.5%) with CVE at Month 24. Comparison is presented only for EVR 1.5 mg vs MMF groups, since EVR 3.0 mg arm was terminated early due to higher mortality. At Month 24, comparable proportion of patients in both EVR and MMF groups (25.8% vs. 25.4%) experienced CVE. The recipients in the MMF group with CVE had higher mean lipid levels (except for HDL), while this correlation was not observed in the EVR group with CVE (Table). Further, the rate of statins usage in recipients of EVR group (88.8%) was lower compared to the MMF group (98.5%) with CVE at Month 24. ConclusionElevated lipid levels in patients treated with EVR+rCsA were not associated with an increase in the incidence of CVE at two years after HTx. Elevated lipid levels in patients treated with EVR+rCsA were not associated with an increase in the incidence of CVE at two years after HTx.