Saito Shigeru, Valdes-Chavarri Mariano, Richardt Gert, Moreno Raul, Iniguez Romo Andrés, Barbato Emanuele, Carrie Didier, Ando Kenji, Merkely Bela, Kornowski Ran, Eltchaninoff Hélène, James Stefan, Wijns William
Shonan Kamakura General Hospital, Kanagawa, Japan.
Hospital Universitaria V. Arrixaca, Murcia, Spain.
Eur Heart J. 2014 Aug 7;35(30):2021-31. doi: 10.1093/eurheartj/ehu210. Epub 2014 May 19.
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.
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.
The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up.
UMIN000006940.
本研究旨在确定新型含生物可吸收聚合物的西罗莫司洗脱支架Ultimaster（BP-SES）的安全性和有效性。在一项名为CENTURY II的临床试验中，将含生物可吸收聚合物的西罗莫司洗脱支架与含依维莫司的永久性聚合物Xience支架（PP-EES）进行了比较，该试验旨在使全球临床数据符合欧洲和日本的监管要求。
CENTURY II是一项前瞻性、多中心、随机（1:1）、单盲、对照、非劣效性临床试验，在日本、欧洲和韩国的58个研究地点进行。共有1123例需要进行经皮冠状动脉介入治疗（PCI）并植入药物洗脱支架（DES）的患者入组[总人群（TP）]。对符合日本DES要求的患者亚组（队列JR，n = 722）进行患者随机分层。两个研究组的基线患者人口统计学和血管造影特征相似，TP和队列JR之间差异极小。主要终点为9个月时无靶病变失败（TLF）-TLF[心源性死亡、靶血管相关心肌梗死（MI）和靶病变血运重建的复合终点]-BP-SES组为95.6%，PP-EES组为95.1%（非劣效性P<0.0001）。心源性死亡和MI复合率分别为2.9%和3.8%（P = 0.40），BP-SES组靶血管血运重建率为4.5%，PP-EES组为4.2%（P = 0.77）。两组的支架血栓形成率均为0.9%。在队列JR中，BP-SES组和PP-EES组的无TLF率分别为95.9%和94.6%（非劣效性P<0.0005）。
在9个月的随访中，新型生物可吸收聚合物西罗莫司洗脱支架的安全性和有效性与耐用聚合物依维莫司洗脱支架相似。
UMIN000006940。
