Key result
Etanercept posttransplant fails to significantly reduce LV mass increase vs placebo at 6 months.
Why the study?
Does etanercept reduce left ventricular mass increase in cardiac transplant recipients?
RCT (n=49)
Double-blind
randomized
Does etanercept reduce left ventricular mass increase in cardiac transplant recipients?
Absolute Event Rate: 19% vs 33%
p-value: p=ns
Etanercept administered immediately post-cardiac transplant may attenuate the increase in LV mass and extracellular matrix deposition, though the primary endpoint difference was not statistically significant.
Etanercept does not significantly limit posttransplant LV mass increase; leaves open whether TNF-alpha blockade attenuates remodeling.
Cardiac allograft hypertrophy is associated with persistent expression of cardiac tumor necrosis factor (TNF)-alpha. We investigated whether TNFalpha antagonism would impact allograft hypertrophy. EFECT (EFfect of Etanercept on Cardiac Transplantation) was a randomized, controlled, double-blind trial evaluating the effect of etanercept versus placebo treatment immediately posttransplant. The primary end-point was change in left ventricular (LV) mass after 6 months. Secondary endpoints included degree of collagen deposition at 6 months and incidence of adverse events. Forty-nine patients were randomized to either etanercept or placebo. LV mass increased significantly in both arms at 6 months, with a smaller increase in the etanercept group (19% vs. 33%, P=ns). Myocardial collagen content increased in the placebo, but not the etanercept, group (+39.8%, P<0.08 vs. -7.0%, P=NS). Allograft hypertrophy develops posttransplant with a corresponding increase in extracellular matrix. Etanercept appeared to decrease LV hypertrophy by decreasing extracellular matrix deposition.
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Torre‐Amione et al. (2007) conducted an RCT in Cardiac allograft hypertrophy (n=49). Etanercept vs. Placebo was evaluated on change in left ventricular (LV) mass after 6 months (p=ns). Etanercept treatment immediately posttransplant resulted in a smaller, non-significant increase in left ventricular mass compared to placebo at 6 months (19% vs. 33%, P=ns).
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