Cardiac allograft vasculopathy by intravascular ultrasound in hearttransplantpatients. Substudy fromthe everolimus versus mycophenolate mofetil randomized, multicenter trial

Jon A. Kobashigawa, Daniel F. Pauly, Randall C. Starling, Howard Eisen, Heather Ross, Shoei Shen Wang, Bernard Cantin, James A. Hill, Patricia Lopez, Gaohong Dong, Stephen J. Nicholls, on behalf of the A2310 IVUS Substudy Investigators

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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.

Original languageEnglish
Pages (from-to)389-399
Number of pages11
JournalJACC: Heart Failure
Volume1
Issue number5
DOIs
Publication statusPublished - 1 Oct 2013
Externally publishedYes

Keywords

  • Cardiac allograft vasculopathy
  • Everolimus
  • Heart transplant
  • Intravascular ultrasound

Cite this

Kobashigawa, J. A., Pauly, D. F., Starling, R. C., Eisen, H., Ross, H., Wang, S. S., Cantin, B., Hill, J. A., Lopez, P., Dong, G., Nicholls, S. J., & on behalf of the A2310 IVUS Substudy Investigators (2013). Cardiac allograft vasculopathy by intravascular ultrasound in hearttransplantpatients. Substudy fromthe everolimus versus mycophenolate mofetil randomized, multicenter trial. JACC: Heart Failure, 1(5), 389-399. https://doi.org/10.1016/j.jchf.2013.07.002