title: Angiographic results of the first human experience with the Biolimus A9 drug-eluting stent for de novo coronary lesions.
abstract: 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.
authors.affiliation: The Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York, USA.
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Ralph
authors.initials: R
authors.lastname: Müeller
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Tsuchiya
authors.forename: Ken
authors.initials: K
authors.lastname: Mori
authors.forename: Ecaterina
authors.initials: E
authors.lastname: Cristea
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: J Eduardo
authors.initials: JE
authors.lastname: Sousa
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmidt
authors.forename: Karl E
authors.initials: KE
authors.lastname: Hauptmann
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
mesh_terms: 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
chemical_list: D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D020123:Sirolimus