Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation
Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation
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DOI：
10.1056/nejmoa0912965
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发表时间：
2010-05-20
影响因子：
158.5
通讯作者：
Valantine, Hannah A.
中科院分区：
文献类型：
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作者：
Pham, Michael X.;Teuteberg, Jeffrey J.;Valantine, Hannah A.
背景：心内膜肌活检是监测心脏移植受者排斥反应的标准方法。然而，这个过程是不舒服的，并且有相关的风险。外周血标本的基因表达谱已被证明与心内膜心肌活检的结果相关。方法：我们随机分配602例6个月至5年前接受心脏移植的患者，除了临床和超声心动图评估移植物功能外，还使用基因表达谱或常规心内膜活检来监测排斥反应。我们对两种方法进行了一项非劣效性比较，其综合主要结果是排斥反应伴血流动力学损害、其他原因导致的移植物功能障碍、死亡或再移植。结果在19个月的中位随访期间，接受基因表达谱监测的患者和接受常规活检的患者复合主要结局的2年累积率相似（分别为14.5%和15.3%；基因表达谱的风险比为1.04；95%可信区间为0.67至1.68）。两组任何原因的2年死亡率也相似（分别为6.3%和5.5%;P = 0.82）。使用基因表达谱进行监测的患者比使用心肌膜活检进行监测的患者每人均年随访的活检次数少(0.5 vs. 3.0， P
BACKGROUNDEndomyocardial biopsy is the standard method of monitoring for rejection in recipients of a cardiac transplant. However, this procedure is uncomfortable, and there are risks associated with it. Gene-expression profiling of peripheral-blood specimens has been shown to correlate with the results of an endomyocardial biopsy.METHODSWe randomly assigned 602 patients who had undergone cardiac transplantation 6 months to 5 years previously to be monitored for rejection with the use of gene-expression profiling or with the use of routine endomyocardial biopsies, in addition to clinical and echocardiographic assessment of graft function. We performed a noninferiority comparison of the two approaches with respect to the composite primary outcome of rejection with hemodynamic compromise, graft dysfunction due to other causes, death, or retransplantation.RESULTSDuring a median follow-up period of 19 months, patients who were monitored with gene-expression profiling and those who underwent routine biopsies had similar 2-year cumulative rates of the composite primary outcome (14.5% and 15.3%, respectively; hazard ratio with gene-expression profiling, 1.04; 95% confidence interval, 0.67 to 1.68). The 2-year rates of death from any cause were also similar in the two groups (6.3% and 5.5%, respectively; P = 0.82). Patients who were monitored with the use of gene-expression profiling underwent fewer biopsies per person-year of follow-up than did patients who were monitored with the use of endomyocardial biopsies (0.5 vs. 3.0, P