A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial.
OBJECTIVE
The aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan.


RESULTS
The CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months-TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]-was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively.


CONCLUSIONS
The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up.


BACKGROUND
UMIN000006940.
Shonan Kamakura General Hospital, Kanagawa, Japan.
Shigeru
S
Saito
Hospital Universitaria V. Arrixaca, Murcia, Spain.
Mariano
M
Valdes-Chavarri
Segeberger Kliniken GmbH, Bad Segeberg, Germany.
Gert
G
Richardt
Hospital La Paz, Madrid, Spain.
Raul
R
Moreno
Hospital Meixoeiro Galaria, Vigo, Spain.
Andrés
A
Iniguez Romo
Cardiovascular Centre Aalst, OLV Hospital, Aalst, Belgium.
Emanuele
E
Barbato
CHU Toulouse Rangeuil, Toulouse, France.
Didier
D
Carrie
Kokura Memorial Hospital, Fukuoka, Japan.
Kenji
K
Ando
Semmelweis University Hospital, Budapest, Hungary.
Bela
B
Merkely
Rabin Medical Centre, Petach-Tikva, Israel.
Ran
R
Kornowski
CHU Charles Nicolle Rouen, Rouen, France.
Hélène
H
Eltchaninoff
Uppsala Akademiska Sjukhus, Uppsala, Sweden.
Stefan
S
James
Cardiovascular Centre Aalst, OLV Hospital, Aalst, Belgium Cardiovascular Centre Aalst, OLV Hospital, Moorselbaan 165, 9301 Aalst, Belgium william.wijns@olvz-aalst.be.
William
W
Wijns
D020341:Absorbable Implants; D000368:Aged; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D017202:Myocardial Ischemia / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus
Bioresorbable polymer; Drug-eluting stent; Everolimus; Randomized trial; Sirolimus