title: Detailed intravascular ultrasound analysis of Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy stent in de novo coronary lesions (results from the ENDEAVOR II trial).
abstract: Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy Driver stents (ZES) demonstrated significant reductions in target lesion revascularization rate with few apparent adverse events compared with bare metal stents (BMS; uncoated Driver stents) in a prospective, multicenter, double-blind, randomized controlled trial in de novo coronary lesions. The aim of this study was to examine detailed vascular responses to ZES compared with BMS using serial intravascular ultrasound analysis. A total of 343 patients (ZES n = 178, BMS n = 165) were enrolled in this formal, prespecified intravascular ultrasound substudy of the Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE Zotarolimus-Eluting Driver Coronary Stent in de Novo Native Coronary Artery Lesions (ENDEAVOR II), a prospective, multicenter, double-blind, randomized controlled trial to compare ZES and BMS in de novo native coronary artery lesions. Quantitative and qualitative intravascular ultrasound analyses were performed postprocedurally and at 8-month follow-up in stented and reference segments. ZES showed significantly less neointima, with a larger lumen than BMS at 8 months (percentage neointimal volume 17.6 +/- 10.1% vs 29.4 +/- 17.2%, p <0.0001; maximum percentage neointimal area 32.9 +/- 13.0% vs 47.6 +/- 18.6%, p <0.0001; minimum luminal area 4.9 +/- 1.6 vs 4.0 +/- 1.7 mm(2), p <0.0001) and no unfavorable edge effect. In the 18-mm single stents, ZES showed evenly inhibited neointima compared with BMS. Neither persistent stent-edge dissection nor late-acquired incomplete stent apposition was observed in either group. In conclusion, ZES showed evenly inhibited neointima with no apparent adverse vascular response in stented and reference segments at 8 months compared with BMS.
authors: Center for Cardiovascular Technology, Stanford University Medical Center, Stanford, California, USA.
authors: Ryota
authors: R
authors: Sakurai
authors: Yoichiro
authors: Y
authors: Hongo
authors: Masao
authors: M
authors: Yamasaki
authors: Yasuhiro
authors: Y
authors: Honda
authors: Heidi N
authors: HN
authors: Bonneau
authors: Paul G
authors: PG
authors: Yock
authors: Donald
authors: D
authors: Cutlip
authors: Jeffrey J
authors: JJ
authors: Popma
authors: Peter
authors: P
authors: Zimetbaum
authors: Jean
authors: J
authors: Fajadet
authors: Richard E
authors: RE
authors: Kuntz
authors: William
authors: W
authors: Wijns
authors: Peter J
authors: PJ
authors: Fitzgerald
mesh_terms: D002858:Chromium Alloys / Q000737:chemistry*; D020099:Coated Materials, Biocompatible / Q000737:chemistry*; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control; D004311:Double-Blind Method; D019160:Endosonography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010767:Phosphorylcholine / Q000737:chemistry*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015607:Stents; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000187:drug effects
chemical_list: D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D010767:Phosphorylcholine; C489443:zotarolimus; D020123:Sirolimus