A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan.
OBJECTIVE
Theoretically, bioresorbable vascular scaffolds (BVSs) may provide superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown.


RESULTS
ABSORB Japan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. cobalt-chromium everolimus-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure [TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR)] at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001]. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001).


CONCLUSIONS
In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs.


BACKGROUND
ClinicalTrials.gov, number NCT01844284.
Department of Cardiovascular Medicine, Kyoto University Hospital, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan taketaka@kuhp.kyoto-u.ac.jp.
Takeshi
T
Kimura
Teikyo University Hospital, Tokyo, Japan.
Ken
K
Kozuma
Division of Cardiology, Cardiac Intensive Care Unit, Mitsui Memorial Hospital, Tokyo, Japan.
Kengo
K
Tanabe
Center of Cardiovascular Medicine, Shin-Tokyo Hospital, Matsudo, Japan.
Sunao
S
Nakamura
Saitama Sekishinkai Hospital, Sayama, Japan.
Masahisa
M
Yamane
Saiseikai Yokohama Tobu Hospital, Yokohama, Japan.
Toshiya
T
Muramatsu
Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan.
Shigeru
S
Saito
Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.
Junji
J
Yajima
Tokyo Women's Medical University Hospital, Tokyo, Japan.
Nobuhisa
N
Hagiwara
Center of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.
Kazuaki
K
Mitsudo
Beth Israel Deaconess Medical Center, Boston, MA, USA.
Jeffrey J
JJ
Popma
Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands Imperial College, London, UK.
Patrick W
PW
Serruys
Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Yoshinobu
Y
Onuma
Abbott Vascular, Santa Clara, CA, USA.
Shihwa
S
Ying
Abbott Vascular, Santa Clara, CA, USA.
Sherry
S
Cao
Abbott Vascular, Santa Clara, CA, USA.
Peter
P
Staehr
Abbott Vascular, Santa Clara, CA, USA.
Wai-Fung
WF
Cheong
Abbott Vascular, Santa Clara, CA, USA.
Hajime
H
Kusano
Columbia University Medical Center, New York-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, NY, USA.
Gregg W
GW
Stone
D020341:Absorbable Implants; D000368:Aged; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000601:surgery; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology; D009204:Myocardial Revascularization / Q000379:methods; D061646:Operative Time; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011474:Prosthesis Design; D016037:Single-Blind Method; D054457:Tissue Scaffolds; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D000068338:Everolimus
Bioresorbable scaffold; Coronary stent; Restenosis; Thrombosis