• Shigeru Saito, Mariano Valdes-Chavarri, Gert Richardt, Raul Moreno, Andrés Iniguez Romo, Emanuele Barbato, Didier Carrie, Kenji Ando, Bela Merkely, Ran Kornowski, Hélène Eltchaninoff, Stefan James, William Wijns, and CENTURY II Investigators.
• Shonan Kamakura General Hospital, Kanagawa, Japan.
• Eur. Heart J. 2014 Aug 7;35(30):2021-31.

AimThe 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.Methods And ResultsThe 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.ConclusionThe new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up.Study Registration NumberUMIN000006940.Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

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