Late-Breaking Clinical Trial: 10-Year Follow-Up of the Everolimus versus Azathioprine Multi-National Study

Abstract

Purpose This study is the 10-year follow-up of a randomized double-blind prospective trial that compared everolimus (1.5 mg or 3 mg) to azathioprine. In the original study of 634 heart transplant patients, there were significantly fewer patients on everolimus who reached the 6 month composite endpoint of death, graft loss or re-transplantation, loss to followup, biopsy-proven acute rejection, or rejection with hemodynamic compromise (36.4% and 27.0%, compared to 46.0%, p Methods This 10-year follow-up study included 364 patients (57% of the original patients) with 116 and 124 patients assigned to everolimus 1.5 mg and 3 mg respectively, and 124 patients assigned to azathioprine. The first analysis includes intent-to-treat by study drug with 10-year endpoint of freedom from a composite endpoint of death, re-transplant, experiencing a coronary stent, myocardial infarction, or development of angiographic CAV. In addition, on-treatment by study drug at 10-years is analyzed for the composite endpoint, individual components of the composite endpoint, left ventricular dysfunction and non-fatal major adverse cardiac events. There were 138 patients with paired IVUS studies (at baseline and 1-year) with 54 patients having first-year change in maximal intimal thickness (MIT) >0.5mm and 84 patients without. Study endpoints for the 2 IVUS groups were the same as above. Further IVUS analysis is performed by study drug assignment and the presence of baseline donor disease. Results 10-year survival, freedom from angiographic CAV or NF-MACE by the intent-to-treat and on-treatment analyses by study drugs (everolimus vs azathioprine) will be revealed. Whether the change in first-year IVUS parameters (specifically change in MIT>0.5mm) can predict 10-year outcome (survival, angiographic CAV or NF-MACE) will also be revealed. Conclusion Findings with conclusions will be discussed at the late-breaking session.