Vascular response to bioresorbable polymer sirolimus-eluting stent vs. permanent polymer everolimus-eluting stent at 9-month follow-up: an optical coherence tomography sub-study from the CENTURY II trial.
OBJECTIVE
The Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES) is a newly developed drug-eluting stent (DES) that consists of a thin-strut, cobalt chromium with bioresorbable polymer coated only albuminally. We sought to compare tissue coverage in coronary lesions treated with BP-SES with the XIENCE permanent polymer everolimus-eluting stent (PP-EES) using optical coherence tomography (OCT).


RESULTS
A total of 36 patients participated in the CENTURY II trial in our institution and were randomly assigned to BP-SES (n = 15) and PP-EES (n = 21). Of these, 27 patients (13 BP-SES and 14 PP-EES) underwent OCT at 9-month follow-up. Tissue coverage and apposition were assessed on each strut, and the results in both groups were compared using multilevel logistic or linear regression models with random effects at three levels: patient, lesion, and struts. A total of 6450 struts (BP-SES, n = 2951; PP-EES, n = 3499) were analysed. Thirty and 79 uncovered struts (1.02 and 2.26%, P = 0.35), and 3 and 4 malapposed struts (0.10 and 0.11%, P = 0.94) were found in BP-SES and PP-EES groups, respectively. Mean neointimal thickness did not significantly differ between both groups (110 ± 10 vs. 93 ± 10 µm, P = 0.22). No significant differences in per cent neointimal volume obstruction (13.2 ± 4.6 vs. 10.5 ± 4.9%, P = 0.14) or other areas-volumetric parameters were detected between both groups.


CONCLUSIONS
BP-SES shows an excellent vascular healing response at 9-month follow-up, which is similar to PP-EES.
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan kuramitsu@circulation.jp.
Shoichi
S
Kuramitsu
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Yoshio
Y
Kazuno
Second Department of Internal Medicine, University of Occupational and Environmental Health Japan School of Medicine, Kitakyushu, Japan.
Shinjo
S
Sonoda
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Takenori
T
Domei
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Hiroyuki
H
Jinnouchi
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Kyohei
K
Yamaji
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Yoshimitsu
Y
Soga
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Shinichi
S
Shirai
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Kenji
K
Ando
Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan.
Shigeru
S
Saito
D020341:Absorbable Implants; D000368:Aged; D000369:Aged, 80 and over; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007564:Japan; D008297:Male; D058426:Neointima; D062645:Percutaneous Coronary Intervention; D011108:Polymers; D011474:Prosthesis Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D041623:Tomography, Optical Coherence / Q000379:methods; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus
Bioresorbable polymer; Coronary artery disease; Optical coherence tomography; Sirolimus-eluting stent