BACKGROUND: The endomyocardial biopsy (EMB) is considered the gold standard in rejection surveillance post cardiac transplant, but is invasive, with risk of complications. A previous trial suggested that the gene expression profiling (GEP) blood test was noninferior to EMB between 6 and 60 months post transplant. As most rejections occur in the first 6 months, we conducted a single-center randomized trial of GEP versus EMB starting at 55 days post transplant (when GEP is valid). METHODS AND RESULTS:Sixty heart transplant patients meeting inclusion criteria were randomized beginning at 55 days post transplant to either GEP or EMB arms. A positive GEP ≥30 between 2 and 6 months, or ≥34 after 6 months, prompted a follow-up biopsy. The primary end point included a composite of death/retransplant, rejection with hemodynamic compromise or graft dysfunction at 18 months post transplant. A coprimary end point included change in first-year maximal intimal thickness by intravascular ultrasound, a recognized surrogate for long-term outcome. Corticosteroid weaning was assessed in both the groups. The composite end point was similar between the GEP and EMB groups (10% versus 17%; log-rank P=0.44). The coprimary end point of first-year intravascular ultrasound change demonstrated no difference in mean maximal intimal thickness (0.35±0.36 versus 0.36±0.26 mm; P=0.944). Steroid weaning was successful in both the groups (91% versus 95%). CONCLUSIONS: In this pilot study, GEP starting at 55 days post transplant seems comparable with EMB for rejection surveillance in selected heart transplant patients and does not result in increased adverse outcomes. GEP also seems useful to guide corticosteroid weaning. Larger randomized trials are required to confirm these findings. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT014182482377.
RCT Entities:
BACKGROUND: The endomyocardial biopsy (EMB) is considered the gold standard in rejection surveillance post cardiac transplant, but is invasive, with risk of complications. A previous trial suggested that the gene expression profiling (GEP) blood test was noninferior to EMB between 6 and 60 months post transplant. As most rejections occur in the first 6 months, we conducted a single-center randomized trial of GEP versus EMB starting at 55 days post transplant (when GEP is valid). METHODS AND RESULTS: Sixty heart transplant patients meeting inclusion criteria were randomized beginning at 55 days post transplant to either GEP or EMB arms. A positive GEP ≥30 between 2 and 6 months, or ≥34 after 6 months, prompted a follow-up biopsy. The primary end point included a composite of death/retransplant, rejection with hemodynamic compromise or graft dysfunction at 18 months post transplant. A coprimary end point included change in first-year maximal intimal thickness by intravascular ultrasound, a recognized surrogate for long-term outcome. Corticosteroid weaning was assessed in both the groups. The composite end point was similar between the GEP and EMB groups (10% versus 17%; log-rank P=0.44). The coprimary end point of first-year intravascular ultrasound change demonstrated no difference in mean maximal intimal thickness (0.35±0.36 versus 0.36±0.26 mm; P=0.944). Steroid weaning was successful in both the groups (91% versus 95%). CONCLUSIONS: In this pilot study, GEP starting at 55 days post transplant seems comparable with EMB for rejection surveillance in selected heart transplant patients and does not result in increased adverse outcomes. GEP also seems useful to guide corticosteroid weaning. Larger randomized trials are required to confirm these findings. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT014182482377.
Authors: Mehmet H Kural; Yuling Li; Juan Wang; Kaleb M Naegeli; Emmanuelle A Hugentobler; Laura E Niklason Journal: Circ Res Date: 2022-06-23 Impact factor: 23.213
Authors: Maria G Crespo-Leiro; Jörg Stypmann; Uwe Schulz; Andreas Zuckermann; Paul Mohacsi; Christoph Bara; Heather Ross; Jayan Parameshwar; Michal Zakliczyński; Roberto Fiocchi; Daniel Hoefer; Mario Deng; Pascal Leprince; David Hiller; Lane Eubank; Emir Deljkich; James P Yee; Johan Vanhaecke Journal: BMC Cardiovasc Disord Date: 2015-10-09 Impact factor: 2.298
Authors: Maria G Crespo-Leiro; Jörg Stypmann; Uwe Schulz; Andreas Zuckermann; Paul Mohacsi; Christoph Bara; Heather Ross; Jayan Parameshwar; Michal Zakliczyński; Roberto Fiocchi; Daniel Hoefer; Monica Colvin; Mario C Deng; Pascal Leprince; Barbara Elashoff; James P Yee; Johan Vanhaecke Journal: Eur Heart J Date: 2016-01-07 Impact factor: 29.983