First-in-man (FIM) study of the Stentys bifurcation stent--30 days results.
OBJECTIVE
We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys bifurcation stent.


RESULTS
The Stentys stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous MI and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side-branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95 +/- 3.63 mm with a bifurcation angle of 55 degrees (range 30 degrees - 80 degrees). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave MI following the procedure and one ischemia-driven revascularisation six days after the procedure.


CONCLUSIONS
This first-in-man (FIM) study demonstrates that the Stentys stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.
Verheye
Stefan
S
Antwerp Cardiovascular Institute, ZNA Middelheim, Interventional Cardiology Lindendreef 1, 2020 Antwerp, Belgium. stefan.verheye@telenet.be
Grube
Eberhard
E
Ramcharitar
Steve
S
Schofer
Joachim J
JJ
Witzenbichler
Bernhard
B
Kovac
Jan
J
Hauptmann
Karl E
KE
Agostoni
Pierfrancesco
P
Wiemer
Marcus
M
Lefèvre
Thierry
T
Serruys
Patrick W
PW
van Geuns
Robert J
RJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000473:pathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D008670:Metals