BACKGROUND: The previously published IMAGE trial showed that Allomap blood test (ABT) was non-inferior to the endomyocardial biopsy (EMB) for patients (pts) between 6 mos and 60 mos after heart transplant (Htx). As most rejections occur within the first 6 mos after Htx, an earlier randomized trial of ABT vs EMB was performed. First year IVUS demonstrating increased coronary artery intimal thickening after heart transplant has been found to be a marker for higher mortality and development of angiographic cardiac allograft vasculopathy (CAV) at 5 years. There has been concern that not performing EMB and missing milder forms of rejection (not detected by ABT) may lead to more CAV. Therefore, IVUS was performed in the study patients to assess long-term effects from the first-year use of ABT vs EMB.

METHODS: Between 2009 and 2011, we randomized 60 Htx pts beginning at 2 mos after Htx (when ABT is valid) to routine EMB or ABT. If ABT was > 30 in the first 6 mos, or > 34 in the second 6 mos then a biopsy was performed. Primary endpoint included a composite of death or re-Htx, hemodynamic compromise w/rejection or graft dysfunction. Co-primary endpoint included IVUS changes from baseline to 12 mos post-Htx.

RESULTS: There was no significant difference in the composite primary endpoint between ABT and EMB groups (p = 0.45). Components of the composite primary endpoint and 1-year echo LV ejection fraction were also similar. First-year IVUS results are pending and will be presented at the meeting.

CONCLUSION: In this pilot study, ABT (starting at 2 mos post Htx) appears comparable to EMB for detection of rejection and does not compromise cardiac function in the 1st year. Pending IVUS data may confirm longterm safety w/ABT.

Kobashigawa, J.: Grant/Research Support, XDx, Inc. Ommert, T.: Grant/Research Support, XDx, Inc.

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