Key result
Mycophenolate mofetil significantly reduced the proportion of heart transplant patients with first-year maximal intimal thickness ≥0.3 mm compared to azathioprine (23% vs 43%, p=0.005).
Why the study?
Does mycophenolate mofetil reduce intimal thickness progression compared to azathioprine in heart transplant patients?
RCT (n=190)
Yes
Does mycophenolate mofetil reduce intimal thickness progression compared to azathioprine in heart transplant patients?
Absolute Event Rate: 23% vs 43%
p-value: p=0.005
Mycophenolate mofetil significantly reduces the progression of first-year intimal thickening compared to azathioprine in heart transplant patients, as assessed by site-to-site IVUS analysis.
Favors mycophenolate mofetil over azathioprine to limit early intimal thickening after heart transplant; confirms IVUS benefit in allograft vasculopathy prevention.
UNLABELLED: The mycophenolate mofetil (MMF) trial involved 650 heart transplant patients from 28 centers who received MMF or azathioprine (AZA), both in combination with cyclosporine and corticosteroids. Baseline and 1-year intravascular ultrasound (IVUS) were performed in 196 patients (102 MMF and 94 AZA) with no differences between groups in IVUS results analyzed by morphometric analysis (average of 10 evenly spaced sites, without matching sites between studies). Baseline to first-year IVUS data can also be analyzed by site-to-site analysis (matching sites between studies), which has been reported to be more clinically relevant. Therefore, we used site-to-site analysis to reanalyze the multicenter MMF IVUS data. RESULTS: IVUS images were reviewed and interpretable in 190 patients (99 MMF and 91 AZA) from the multicenter randomized trial. The AZA group compared to the MMF group had a larger number of patients with first-year maximal intimal thickness (MIT)>or=0.3 mm (43% vs. 23%, p=0.005), a greater decrease in the mean lumen area (p=0.02) and a decrease in the mean vessel area (the area actually increased in the MMF group, p=0.03). CONCLUSION: MMF-treated heart transplant patients compared to AZA-treated patients, both concurrently on cyclosporine and corticosteroids, in this study have significantly less progression of first-year intimal thickening.
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Kobashigawa et al. (2006) conducted an RCT in Heart transplant (n=190). Mycophenolate mofetil (MMF) vs. Azathioprine (AZA) was evaluated on First-year maximal intimal thickness (MIT) ≥0.3 mm (p=0.005). Mycophenolate mofetil significantly reduced the proportion of heart transplant patients with first-year maximal intimal thickness ≥0.3 mm compared to azathioprine (23% vs 43%, p=0.005).
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