Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial

on behalf of CENTURY II study investigators

Research output: Contribution to journalArticle

Abstract

Objectives: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. Background: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. Methods: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. Results: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p =.29 and 10.2 vs. 13.4%; p =.29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p =.33 and 0.9 vs. 1.7%; p =.43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. Conclusions: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

Original languageEnglish
JournalCatheterization and Cardiovascular Interventions
DOIs
Publication statusPublished - Jan 1 2019
Externally publishedYes

Fingerprint

Sirolimus
Stents
Coronary Artery Disease
Polymers
Randomized Controlled Trials
Myocardial Infarction
Safety
Benchmarking
Drug-Eluting Stents
Random Allocation
Everolimus
Multicenter Studies
Thrombosis
Therapeutics
Population

Keywords

  • clinical trials
  • complex PCI
  • coronary artery disease
  • drug eluting
  • percutaneous coronary intervention, stent
  • stent design/structure/coating

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

@article{3dff1d3edafc46b7a80138fa3e031598,
title = "Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial",
abstract = "Objectives: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. Background: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. Methods: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. Results: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8{\%}; p =.29 and 10.2 vs. 13.4{\%}; p =.29), and definite or probable stent thrombosis (0.4 vs. 1.3{\%}; p =.33 and 0.9 vs. 1.7{\%}; p =.43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. Conclusions: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.",
keywords = "clinical trials, complex PCI, coronary artery disease, drug eluting, percutaneous coronary intervention, stent, stent design/structure/coating",
author = "{on behalf of CENTURY II study investigators} and Andr{\'e}s I{\~n}iguez and Bernard Chevalier and Gert Richardt and Antoinette Neylon and Jim{\'e}nez, {Victor A.} and Ran Kornowski and Didier Carrie and Raul Moreno and Emanuele Barbato and Antoni Serra-Pe{\~n}aranda and Vincenzo Guiducci and Mariano Vald{\'e}s-Ch{\'a}varri and Junji Yajima and William Wijns and Shigeru Saito",
year = "2019",
month = "1",
day = "1",
doi = "10.1002/ccd.28224",
language = "English",
journal = "Catheterization and Cardiovascular Interventions",
issn = "1522-1946",
publisher = "John Wiley and Sons Inc.",

}

TY - JOUR

T1 - Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent

T2 - 5-year results of the CENTURY II randomized clinical trial

AU - on behalf of CENTURY II study investigators

AU - Iñiguez, Andrés

AU - Chevalier, Bernard

AU - Richardt, Gert

AU - Neylon, Antoinette

AU - Jiménez, Victor A.

AU - Kornowski, Ran

AU - Carrie, Didier

AU - Moreno, Raul

AU - Barbato, Emanuele

AU - Serra-Peñaranda, Antoni

AU - Guiducci, Vincenzo

AU - Valdés-Chávarri, Mariano

AU - Yajima, Junji

AU - Wijns, William

AU - Saito, Shigeru

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objectives: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. Background: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. Methods: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. Results: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p =.29 and 10.2 vs. 13.4%; p =.29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p =.33 and 0.9 vs. 1.7%; p =.43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. Conclusions: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

AB - Objectives: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. Background: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. Methods: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. Results: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p =.29 and 10.2 vs. 13.4%; p =.29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p =.33 and 0.9 vs. 1.7%; p =.43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. Conclusions: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

KW - clinical trials

KW - complex PCI

KW - coronary artery disease

KW - drug eluting

KW - percutaneous coronary intervention, stent

KW - stent design/structure/coating

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U2 - 10.1002/ccd.28224

DO - 10.1002/ccd.28224

M3 - Article

AN - SCOPUS:85065167685

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

ER -