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Eur Heart J. 2014 Aug 7;35(30):2021-31. doi: 10.1093/eurheartj/ehu210. Epub 2014 May 19.

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.

Author information

1
Shonan Kamakura General Hospital, Kanagawa, Japan.
2
Hospital Universitaria V. Arrixaca, Murcia, Spain.
3
Segeberger Kliniken GmbH, Bad Segeberg, Germany.
4
Hospital La Paz, Madrid, Spain.
5
Hospital Meixoeiro Galaria, Vigo, Spain.
6
Cardiovascular Centre Aalst, OLV Hospital, Aalst, Belgium.
7
CHU Toulouse Rangeuil, Toulouse, France.
8
Kokura Memorial Hospital, Fukuoka, Japan.
9
Semmelweis University Hospital, Budapest, Hungary.
10
Rabin Medical Centre, Petach-Tikva, Israel.
11
CHU Charles Nicolle Rouen, Rouen, France.
12
Uppsala Akademiska Sjukhus, Uppsala, Sweden.
13
Cardiovascular Centre Aalst, OLV Hospital, Aalst, Belgium Cardiovascular Centre Aalst, OLV Hospital, Moorselbaan 165, 9301 Aalst, Belgium william.wijns@olvz-aalst.be.

Abstract

AIM:

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.

METHODS AND 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.

CONCLUSION:

The 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 NUMBER:

UMIN000006940.

KEYWORDS:

Bioresorbable polymer; Drug-eluting stent; Everolimus; Randomized trial; Sirolimus

PMID:
24847155
PMCID:
PMC4200026
DOI:
10.1093/eurheartj/ehu210
[Indexed for MEDLINE]
Free PMC Article

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