Short- and mid-term intravascular ultrasound analysis of the new zotarolimus-eluting stent with durable polymer – results from the RESOLUTE trial –.
BACKGROUND
The Resolute stent is a newly developed system with a bio-histocompatible polymer that allows programmed drug delivery up to 180 days. The aim of this intravascular ultrasound (IVUS) analysis was to evaluate the short- (4 months) and mid-term (9 months) efficacy using the Resolute stent.


RESULTS
Data were derived from the RESOLUTE trial, a prospective, multicenter, non-randomized, single-arm study to treat de novo native coronary artery lesions. This trial included 2 cohorts with different follow-up periods, and all enrollment patients in this trial received IVUS study. Follow-up IVUS was available in 24 patients (4-month group) and 88 patients (9-month group). Neointimal obstruction (%) was defined as neointimal volume divided by stent volume. Cross-sectional narrowing (CSN, %) was defined as neointimal area divided by stent area. No significant differences in vessel, lumen and stent volume at post-procedure were observed within stented segments between the 4- and 9-month follow-up groups. Although neointimal volume and % neointimal obstruction showed no significant difference between the 2 groups (% neointimal obstruction: 2.2 ± 2.5 vs 3.7 ± 4.0%, P=0.09), maximum CSN was significantly larger in the 9-month group. There were 7 cases of late incomplete stent apposition.


CONCLUSIONS
These IVUS results showed minimum growth of neointimal proliferation by the Resolute stent throughout the stented segment up to 9 months follow up.
Waseda
Katsuhisa
K
Stanford University Medical Center, Stanford, CA 94305, USA.
Ako
Junya
J
Yamasaki
Masao
M
Koizumi
Tomomi
T
Ormiston
John
J
Worthley
Stephen G
SG
Whitbourn
Robert J
RJ
Walters
Darren L
DL
Honda
Yasuhiro
Y
Meredith
Ian T
IT
Fitzgerald
Peter J
PJ
D000368:Aged; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000473:pathology; D011108:Polymers / Q000627:therapeutic use*; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D018084:Ultrasonography, Interventional
D011108:Polymers; C489443:zotarolimus; D020123:Sirolimus