Cardiac allograft vasculopathy by intravascular ultrasound in hearttransplantpatients. Substudy fromthe everolimus versus mycophenolate mofetil randomized, multicenter trial
Journal
JACC: Heart Failure
Journal Volume
1
Journal Issue
5
Pages
389-399
Date Issued
2013
Author(s)
Kobashigawa J.A.
Pauly D.F.
Starling R.C.
Eisen H.
Ross H.
Cantin B.
Hill J.A.
Lopez P.
Dong G.
Nicholls S.J.
Abstract
Objectives: A pre-planned substudy of a larger multicenter randomized trial was undertaken to compare the efficacy of everolimus with reduced-dose cyclosporine in the prevention of cardiac allograft vasculopathy (CAV) after heart transplantation to that of mycophenolate mofetil (MMF) with standard-dose cyclosporine. Background: CAV is a major cause of long-term mortality following heart transplantation. Everolimus has been shown to reduce the severity and incidence of CAV as measured by first year intravascular ultrasound (IVUS). MMF, in combination with cyclosporine, has also been shown to have a beneficial effect in slowing the progression of CAV. Methods: Study patients were a pre-specified subgroup of the 553. -patient Everolimus versus mycophenolate mofetil in heart transplantation: a randomized, multicenter trial who underwent heart transplantation and were randomized to everolimus 1.5 mg or MMF 3 g/day. IVUS was performed at baseline and at 12 months. Evaluable IVUS data were available in 189 patients (34.6%). Results: Increase in average maximal intimal thickness (MIT) from baseline to month 12 was significantly smaller in the everolimus 1.5 mg group compared with the MMF group (0.03 mm vs. 0.07 mm, p< 0.001). The incidence of CAV, defined as an increase in MIT from baseline to month 12 of greater than 0.5 mm, was 12.5% with everolimus versus 26.7% with MMF (p= 0.018). These findings remained irrespective of sex, age, diabetic status, donor disease, and across lipid categories. Conclusions: Everolimus was significantly more efficacious than MMF in preventing CAV as measured by IVUS among heart-transplant recipients after 1 year, a finding, which was maintained in a range of patient subpopulations. CV surgery: transplantation, ventricular assistance, cardiomyopathy. ? 2013 American College of Cardiology Foundation.
SDGs
Other Subjects
cholesterol; cyclosporin; everolimus; ganciclovir; high density lipoprotein cholesterol; hyperimmune globulin; low density lipoprotein cholesterol; mycophenolic acid 2 morpholinoethyl ester; triacylglycerol; valaciclovir; valganciclovir; everolimus; immunosuppressive agent; mycophenolic acid; mycophenolic acid 2 morpholinoethyl ester; rapamycin; acute graft rejection; adult; age; article; cardiac allograft vasculopathy; cardiomyopathy; cardiovascular risk; Caucasian; cholesterol blood level; controlled study; cytomegalovirus infection; diabetes mellitus; disease course; donor age; drug dose reduction; drug efficacy; female; graft recipient; heart transplantation; human; incidence; intravascular ultrasound; major clinical study; male; maximal intimal thickness; multicenter study; priority journal; randomized controlled trial; sex; thickness; triacylglycerol blood level; analogs and derivatives; clinical trial; comparative study; coronary artery disease; echography; endoscopic echography; heart transplantation; middle aged; Postoperative Complications; Coronary Artery Disease; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Mycophenolic Acid; Postoperative Complications; Sirolimus; Ultrasonography, Interventional
Type
journal article