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European Heart Journal Advance Access originally published online on April 30, 2009
European Heart Journal 2009 30(12):1477-1485; doi:10.1093/eurheartj/ehp127
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

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

Yoshinobu Onuma1, Patrick Serruys1,*, Peter den Heijer2, Kaiyum Sheik Joesoef3, Henricus Duckers1, Evelyn Regar1, Neville Kukreja1, Shuzou Tanimoto1, Hector M. Garcia-Garcia4, Heleen van Beusekom1, Willem van der Giessen1 and Takuji Nishide5

1 Thoraxcenter, Erasmus Medical Center, Ba-583, s-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands
2 AMPHIA Hospital, Breda, The Netherlands
3 Medisch Centrum Rijnmond Zuid, Rotterdam, The Netherlands
4 Cardialysis B.V., Rotterdam, The Netherlands
5 Kaneka Corporation, Osaka, Japan

Received 8 September 2008; revised 5 February 2009; accepted 11 March 2009; online publish-ahead-of-print 30 April 2009.

* Corresponding author. Tel: +31 10 4635260, Fax: +31 10 4369154, Email: p.w.j.c.serruys{at}erasmusmc.nl

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 MAHOROBATM 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.

Key Words: Tacrolimus-eluting stent • First-in-man study • Drug-eluting stent • Coronary artery disease


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