Angiographic results of the first human experience with the Biolimus A9 drug-eluting stent for de novo coronary lesions.
This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronary lesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, < or = 24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n = 80, 82 lesions) or the control uncoated stent (n = 40). Baseline lesion and angiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 +/- 0.43 vs 0.74 +/- 0.45 mm, p < 0.001) and in the segment (0.14 +/- 0.45 vs 0.40 +/- 0.41 mm, p = 0.004). In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p = 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.
Costa
Ricardo A
RA
The Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York, USA.
Lansky
Alexandra J
AJ
Abizaid
Alexandre
A
Müeller
Ralph
R
Tsuchiya
Yoshihiro
Y
Mori
Ken
K
Cristea
Ecaterina
E
Leon
Martin B
MB
Sousa
J Eduardo
JE
Schmidt
Thomas
T
Hauptmann
Karl E
KE
Grube
Eberhard
E
D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000601:surgery; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use*; D015607:Stents; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D020123:Sirolimus