Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation

Final five-year results of the CENTURY II randomised clinical trial

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

Research output: Contribution to journalArticle

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Abstract

Aims: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). Methods and results: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. Conclusions: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.

Original languageEnglish
Pages (from-to)e343-e351
JournalEuroIntervention
Volume14
Issue number3
DOIs
Publication statusPublished - Jun 1 2018

Fingerprint

Drug-Eluting Stents
Stents
Polymers
Randomized Controlled Trials
Percutaneous Coronary Intervention
Myocardial Infarction
Safety
Benchmarking
Sirolimus
Korea
Coronary Artery Disease
Japan
Thrombosis

Keywords

  • Clinical trials
  • Drug-eluting stent
  • Multiple vessel disease
  • Single vessel disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation : Final five-year results of the CENTURY II randomised clinical trial. / Wijns, William; Valdes-Chavarri, Mariano; Richardt, Gert; Moreno, Raul; Iniguez-Romo, Andres; Barbato, Emanuele; Carrie, Didier; Ando, Kenji; Merkely, B.; Kornowski, Ran; Eltchaninoff, Hélène; Stojkovic, Sinisa; Saito, Shigeru.

In: EuroIntervention, Vol. 14, No. 3, 01.06.2018, p. e343-e351.

Research output: Contribution to journalArticle

Wijns, W, Valdes-Chavarri, M, Richardt, G, Moreno, R, Iniguez-Romo, A, Barbato, E, Carrie, D, Ando, K, Merkely, B, Kornowski, R, Eltchaninoff, H, Stojkovic, S & Saito, S 2018, 'Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation: Final five-year results of the CENTURY II randomised clinical trial', EuroIntervention, vol. 14, no. 3, pp. e343-e351. https://doi.org/10.4244/EIJ-D-18-00358
Wijns, William ; Valdes-Chavarri, Mariano ; Richardt, Gert ; Moreno, Raul ; Iniguez-Romo, Andres ; Barbato, Emanuele ; Carrie, Didier ; Ando, Kenji ; Merkely, B. ; Kornowski, Ran ; Eltchaninoff, Hélène ; Stojkovic, Sinisa ; Saito, Shigeru. / Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation : Final five-year results of the CENTURY II randomised clinical trial. In: EuroIntervention. 2018 ; Vol. 14, No. 3. pp. e343-e351.
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abstract = "Aims: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). Methods and results: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0{\%} in the BP-SES and 91.1{\%} in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6{\%} (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2{\%} in both arms. Conclusions: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.",
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T2 - Final five-year results of the CENTURY II randomised clinical trial

AU - Wijns, William

AU - Valdes-Chavarri, Mariano

AU - Richardt, Gert

AU - Moreno, Raul

AU - Iniguez-Romo, Andres

AU - Barbato, Emanuele

AU - Carrie, Didier

AU - Ando, Kenji

AU - Merkely, B.

AU - Kornowski, Ran

AU - Eltchaninoff, Hélène

AU - Stojkovic, Sinisa

AU - Saito, Shigeru

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N2 - Aims: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). Methods and results: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. Conclusions: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.

AB - Aims: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). Methods and results: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. Conclusions: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.

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KW - Single vessel disease

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