Randomized comparison of biolimus-eluting stents with biodegradable polymer versus everolimus-eluting stents with permanent polymer coatings assessed by optical coherence tomography.
We sought to compare the healing patterns of biolimus-eluting stents with biodegradable polymer (BP-BES, Nobori) versus everolimus-eluting stents with permanent polymer (PP-EES, Xience) using intravascular optical coherence tomography (OCT). A total of 34 patients undergoing treatment of de novo coronary lesions were randomly assigned to receive BP-BES (n = 15) or PP-EES (n = 19). Stent tissue coverage and apposition as well as the incidence of peri-strut low intensity area (PLIA) were assessed by OCT at 6-8 months. Generalized linear mixed models were used to account for clustered data. OCT imaging was available for 17 lesions with 2,805 struts in the BP-BES group and 22 lesions with 3,890 struts in the PP-EES group. BP-BES as compared to PP-EES showed similar rates of uncovered struts (479 vs. 588, odds ratio (OR) 1.54 (95 % CI 0.63-3.79), P = 0.34) and malapposed struts (46 vs. 32 struts, OR 1.64 [95 % CI 0.21-12.5], P = 0.64). Three lesions with BP-BES (17.6 %) versus 5 lesions with PP-EES (22.7 %) had >30 % uncovered struts (P = 0.78). The proportion of patients with PLIA was similar in both groups (BP-BES 41.2 % vs. PP-EES 36.4 %, OR 1.11 [95 % CI 0.43-2.87], P = 0.83). New generation BP-BES as compared to PP-EES showed similar stent coverage and apposition as assessed by OCT at 6-8 months. In addition, PLIA-possible markers of delayed arterial healing-were observed with similar frequency in both groups.
Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, 80636, Munich, Germany, tomohisa@kuhp.kyoto-u.ac.jp.
Tomohisa
T
Tada
Adnan
A
Kastrati
Robert A
RA
Byrne
Tibor
T
Schuster
Rezarta
R
Cuni
Lamin A
LA
King
Salvatore
S
Cassese
Michael
M
Joner
Jürgen
J
Pache
Steffen
S
Massberg
Albert
A
Schömig
Julinda
J
Mehilli
D000368:Aged; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000517:prevention & control; D003331:Coronary Vessels / Q000187:drug effects; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007091:Image Processing, Computer-Assisted / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008422:Materials Testing; D016017:Odds Ratio; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D041623:Tomography, Optical Coherence / Q000379:methods*; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D011108:Polymers; D000068338:Everolimus; C518022:umirolimus; D020123:Sirolimus