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


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%.


CONCLUSIONS
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.
Onuma
Yoshinobu
Y
Thoraxcenter, Erasmus Medical Center, Ba-583, s-Gravendijkwal 230, Rotterdam, The Netherlands.
Serruys
Patrick
P
den Heijer
Peter
P
Joesoef
Kaiyum Sheik
KS
Duckers
Henricus
H
Regar
Evelyn
E
Kukreja
Neville
N
Tanimoto
Shuzou
S
Garcia-Garcia
Hector M
HM
van Beusekom
Heleen
H
van der Giessen
Willem
W
Nishide
Takuji
T
D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016559:Tacrolimus / Q000627:therapeutic use*; D013927:Thrombosis / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D017539:Tunica Intima / Q000473:pathology; D018084:Ultrasonography, Interventional
D007166:Immunosuppressive Agents; D016559:Tacrolimus