MAHOROBA, first-in-man study: 6-month results of a biodegradable polymer sustained release tacrolimus-eluting stent in de novo coronary stenoses
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.
|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|
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