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

Shigeru Saito, Mariano Valdes-Chavarri, Gert Richardt, Raul Moreno, Andrés Iniguez Romo, Emanuele Barbato, Didier Carrie, Kenji Ando, B. Merkely, Ran Kornowski, Hélène Eltchaninoff, Stefan James, William Wijns

Research output: Contribution to journalArticle

94 Citations (Scopus)

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-inferioritynon-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.

Original languageEnglish
Pages (from-to)2021-2031
Number of pages11
JournalEuropean Heart Journal
Volume35
Issue number30
DOIs
Publication statusPublished - Aug 7 2014

Fingerprint

Drug-Eluting Stents
Sirolimus
Stents
Coronary Artery Disease
Polymers
Japan
Therapeutics
Clinical Trials
Safety
Percutaneous Coronary Intervention
Korea
Random Allocation
Population
Myocardial Infarction
Demography

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

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. / Saito, Shigeru; Valdes-Chavarri, Mariano; Richardt, Gert; Moreno, Raul; Romo, Andrés Iniguez; Barbato, Emanuele; Carrie, Didier; Ando, Kenji; Merkely, B.; Kornowski, Ran; Eltchaninoff, Hélène; James, Stefan; Wijns, William.

In: European Heart Journal, Vol. 35, No. 30, 07.08.2014, p. 2021-2031.

Research output: Contribution to journalArticle

Saito, Shigeru ; Valdes-Chavarri, Mariano ; Richardt, Gert ; Moreno, Raul ; Romo, Andrés Iniguez ; Barbato, Emanuele ; Carrie, Didier ; Ando, Kenji ; Merkely, B. ; Kornowski, Ran ; Eltchaninoff, Hélène ; James, Stefan ; Wijns, William. / 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. In: European Heart Journal. 2014 ; Vol. 35, No. 30. pp. 2021-2031.
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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-inferioritynon-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.",
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T1 - A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system

T2 - The CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial

AU - Saito, Shigeru

AU - Valdes-Chavarri, Mariano

AU - Richardt, Gert

AU - Moreno, Raul

AU - Romo, Andrés Iniguez

AU - Barbato, Emanuele

AU - Carrie, Didier

AU - Ando, Kenji

AU - Merkely, B.

AU - Kornowski, Ran

AU - Eltchaninoff, Hélène

AU - James, Stefan

AU - Wijns, William

PY - 2014/8/7

Y1 - 2014/8/7

N2 - 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-inferioritynon-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.

AB - 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-inferioritynon-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.

KW - Bioresorbable polymer

KW - Drug-eluting stent

KW - Everolimus

KW - Randomized trial

KW - Sirolimus

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