Randomized Pilot Trial of Gene Expression Profiling Versus Heart Biopsy in the First Year After Heart Transplant: Early Invasive Monitoring Attenuation Through Gene Expression Trial (EIMAGE)
Kobashigawa MD, Patel J, et al.Circulation. Heart Failure. 2015 May; 8(3): 557-64
Aims
To compare GEP (gene expression profiling) and EBM (endomyocardial biopsy) as methods of rejection surveillance from 55 days onwards post cardiac transplant.
Interventions
Monitoring for rejection starting at 55 days, 3,4,5,6,8,10 and 12 months post-transplant.
Participants
60 heart transplant patients randomized to GEP (n=30)or EMB (n=30)
Outcomes
The primary endpoint was a composite of death/retransplant, rejection with hemodynamic compromise or graft dysfunction at 18-months post-transplant. Another primary endpoint included change in first-year maximal thickness measured by intravascular ultrasound. Corticosteroid weaning was also assessed.
Follow-up
18 months
CET Conclusions
This is an interesting pilot study in which the authors in a single centre randomised trial have attempted to assess the value of gene expression profiling (GEP) using blood in comparison to the gold standard for diagnosing rejection, namely endomyocardial biopsy. Sixty patients were recruited who met the inclusion criteria and the primary endpoint included a composite of death or retransplant, rejection with haemodynamic compromise or graft dysfunction up to 18 months after transplant. They also assessed intimal thickness using intravascular ultrasound. The study started 55 days after transplant and it did appear that the two methods of detecting rejection were comparable in these very selected heart transplant patients and no adverse outcomes were noted. It also appeared that the GEP was a useful guide to weaning the patients off steroids. However there are considerable limitations to the study in that it was not sufficiently powered, and a small sample size makes it difficult to draw conclusions to which the authors have drawn our attention. There were also very few primary endpoints experienced as only 8 patients in both arms reached the composite primary endpoint. Nevertheless this is sufficiently encouraging to plan a much larger trial and furthermore GEP may also guide the weaning of patient off steroids. Further large scale clinical trials will be needed to confirm these potentially interesting results. However it should be noted that the bioinformatics and interpretation was carried out by the sponsor company.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov-NCT 00962377