Initial and follow-up results of the BiodivYsio phosphorylcholine coated stent for treatment of coronary artery disease.
BACKGROUND
The BiodivYsio stent is coated with a phosphorylcholine containing copolymer to confer biocompatibility. The present study was designed to assess the safety and efficacy of this coronary stent for the treatment of native coronary artery lesions in patients with coronary artery disease.


RESULTS
From August 2001 to April 2003, 130 patients with lesions were treated with this stent. Elective stenting (ES) was performed in 90 patients and bailout stenting (BS) was performed in 40 patients with small vessels. Pre-interventional reference diameter, minimal lumen diameter (MLD), and lesion length were 2.68+/-0.51, 1.00+/-0.30, 12.78+/-4.32, respectively, and post-interventional MLD was 2.24+/-0.45 mm. The initial success rate was 100%. However, 2 non-Q-wave myocardial infarctions (non-QMI) occurred post-procedurally due to branch occlusion. A 6-month follow-up was performed. No subacute thrombosis occurred. In the ES group, 1 non-QMI occurred after the interventional procedure in another vessel. There was no death or coronary artery bypass grafting (CABG). The angiographic restenosis rate was 15.6%. In the BS group, there was no death, myocardial infarction or CABG. The angiographic restenosis rate was 17.5%.


CONCLUSIONS
The BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions, especially in small vessels.
Shinozaki
Norihiko
N
Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan. kmhptca@nn.iij4u.or.jp
Yokoi
Hiroyoshi
H
Iwabuchi
Masashi
M
Nosaka
Hideyuki
H
Kadota
Kazushige
K
Mitsudo
Kazuaki
K
Nobuyoshi
Masakiyo
M
D000368:Aged; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000601:surgery / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization; D010767:Phosphorylcholine / Q000627:therapeutic use*; D019919:Prosthesis Implantation / Q000379:methods; D015607:Stents / Q000009:adverse effects / Q000592:standards*; D017211:Treatment Failure
D020099:Coated Materials, Biocompatible; D010767:Phosphorylcholine