Detailed intravascular ultrasound analysis of Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy stent in de novo coronary lesions (results from the ENDEAVOR II trial).
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.
Sakurai
Ryota
R
Center for Cardiovascular Technology, Stanford University Medical Center, Stanford, California, USA.
Hongo
Yoichiro
Y
Yamasaki
Masao
M
Honda
Yasuhiro
Y
Bonneau
Heidi N
HN
Yock
Paul G
PG
Cutlip
Donald
D
Popma
Jeffrey J
JJ
Zimetbaum
Peter
P
Fajadet
Jean
J
Kuntz
Richard E
RE
Wijns
William
W
Fitzgerald
Peter J
PJ
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
D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D010767:Phosphorylcholine; C489443:zotarolimus; D020123:Sirolimus