THURSDAY, April 22 (HealthDay News) -- The use of gene-expression profiling to monitor for rejection in cardiac transplant recipients at low risk of rejection may be just as effective and safe, with fewer biopsies performed, as routine endomyocardial biopsy monitoring, according to a study published online April 22 in the New England Journal of Medicine to coincide with a presentation at the annual meeting of the International Society for Heart & Lung Transplantation, held from April 21 to 24 in Chicago.
Michael X. Pham, M.D., the of Stanford University Medical Center in California, and colleagues randomized 602 patients who had undergone cardiac transplantation six months to five years previously to be monitored for rejection with use of gene-expression profiling or routine endomyocardial biopsies, in addition to echocardiographic and clinical assessment of graft function. The composite primary outcome was rejection with hemodynamic compromise, graft dysfunction due to other causes, death, or retransplantation.
In a median follow-up of 19 months, the researchers found that those who underwent gene-expression profiling had similar two-year cumulative rates of the composite primary outcome compared with those who underwent routine endomyocardial biopsies (14.5 versus 15.3 percent). The two-year rates of death from any cause in the two groups were 6.3 and 5.5 percent, respectively (P = 0.82), and those in the gene-expression profiling group had fewer biopsies per person-year of follow-up than those in the endomyocardial biopsies group (0.5 versus 3.0, P < 0.001).
"Among selected patients who had received a cardiac transplantation more than six months previously and who were at a low risk for rejection, a strategy of monitoring for rejection that involved gene-expression profiling, as compared with routine biopsies, was not associated with an increased risk of serious adverse outcomes and resulted in the performance of significantly fewer biopsies," the authors write.
The study was supported by XDx, maker of the AlloMap test. Stanford University holds equity in XDx.
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