AimsTo 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 resultsA 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.ConclusionThis 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.

Additional Metadata
Keywords Coronary artery disease, Drug-eluting stent, First-in-man study, Tacrolimus-eluting stent
Persistent URL dx.doi.org/10.1093/eurheartj/ehp127, hdl.handle.net/1765/24649
Citation
Onuma, Y, Serruys, P.W.J.C, den Heijer, P, Joesoef, K.S, Duckers, H.J, Regar, E.S, … Nishide, T. (2009). MAHOROBA, first-in-man study: 6-month results of a biodegradable polymer sustained release tacrolimus-eluting stent in de novo coronary stenoses. European Heart Journal, 30(12), 1477–1485. doi:10.1093/eurheartj/ehp127