Key result
The MAHOROBA tacrolimus-eluting stent failed to prevent neointimal hyperplasia, resulting in an in-stent late loss of 0.99 mm at 4 months and a 23.4% MACE rate at 6 months.
Why the study?
Does a tacrolimus-eluting bioabsorbable polymer-coated stent prevent neointimal hyperplasia in patients with de novo coronary stenoses?
Does a tacrolimus-eluting bioabsorbable polymer-coated stent prevent neointimal hyperplasia in patients with de novo coronary stenoses?
The tacrolimus-eluting MAHOROBA stent failed to prevent neointimal hyperplasia, resulting in high rates of late loss and repeat revascularization.
Tacrolimus-eluting stents warrant no clinical adoption; leaves open whether alternative agents can suppress neointimal hyperplasia in de novo lesions.
AIMS: To report the 4-month angiographic and 6-month clinical follow-up in first-in-man study using the tacrolimus-eluting bioabsorbable polymer-coated cobalt-chromium MAHOROBA stent. METHODS AND RESULTS: A total of 47 patients with either stable angina or unstable angina, or silent myocardial ischaemia, based on a de novo coronary stenosis that could be covered by a single 18 mm stent in a native coronary artery with a diameter between 3.0 and 3.5 mm were enrolled at three sites. The primary endpoint was in-stent late loss at 4 months. The secondary endpoints include %volume obstruction of the stents assessed by intravascular ultrasound (IVUS) at 4 months and major adverse cardiac events (MACE) at 6 months. Forty-seven patients were enrolled. Procedural success was achieved in 97.9%. At 4-month follow-up, in-stent late loss was 0.99 +/- 0.46 mm, whereas in-stent %volume obstruction in IVUS was 34.8 +/- 15.8%. At 6 months, there were no deaths, but 2 patients suffered from a myocardial infarction and 11 patients required ischaemia-driven repeat revascularization. The composite MACE rate was 23.4%. CONCLUSION: This tacrolimus-eluting stent failed to prevent neointimal hyperplasia, despite the theoretical advantages of the tacrolimus, which has less inhibitory effects on endothelial cells than smooth muscle cells.
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Onuma et al. (2009) studied de novo coronary stenosis (n=47). MAHOROBA tacrolimus-eluting bioabsorbable polymer-coated cobalt-chromium stent was evaluated on in-stent late loss at 4 months. The MAHOROBA tacrolimus-eluting stent failed to prevent neointimal hyperplasia, resulting in an in-stent late loss of 0.99 mm at 4 months and a 23.4% MACE rate at 6 months.
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