Objectives:To assess the long-term safety and efficacy of a sirolimus-eluting stent withbioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patientswith 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 effi-cacy 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 IIprospective, randomized, single-blind, multicenter trial, a prespecified subgroup of456 MVD patients were allocated by stratified randomization to treatment withBP-SES (n= 225) or PP-EES (n= 231). The previously reported primary endpoint ofthis study was freedom from target lesion failure (TLF: a composite of cardiac death,target vessel-related myocardial infarction [MI] and clinically-indicated target lesionrevascularization) at 9 months.Results:In this MVD substudy, baseline patient, lesion and procedure characteristicswere similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES dsplayed 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 0.9vs. 1.7%;p= .43), respectively. Composite endpoint of cardiac death and MI, andpatient-oriented composite endpoint of any death, MI, and coronary revasculariza-tions were also similar.Conclusions:These results confirm good long-term safety and efficacy of the studiedbioresorbable polymer stent in this high-risk patient population.

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 / Iniguez, A.; Chevalier, B.; Richardt, G.; Neylon, A.; Jimenez, V. A.; Kornowski, R.; Carrie, D.; Moreno, R.; Barbato, E.; Serra-Penaranda, A.; Guiducci, V.; Valdes-Chavarri, M.; Yajima, J.; Wijns, W.; Saito, S.. - In: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. - ISSN 1522-1946. - 95:2(2020), pp. 175-184. [10.1002/ccd.28224]

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

Barbato E.;
2020

Abstract

Objectives:To assess the long-term safety and efficacy of a sirolimus-eluting stent withbioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patientswith 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 effi-cacy 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 IIprospective, randomized, single-blind, multicenter trial, a prespecified subgroup of456 MVD patients were allocated by stratified randomization to treatment withBP-SES (n= 225) or PP-EES (n= 231). The previously reported primary endpoint ofthis study was freedom from target lesion failure (TLF: a composite of cardiac death,target vessel-related myocardial infarction [MI] and clinically-indicated target lesionrevascularization) at 9 months.Results:In this MVD substudy, baseline patient, lesion and procedure characteristicswere similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES dsplayed 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 0.9vs. 1.7%;p= .43), respectively. Composite endpoint of cardiac death and MI, andpatient-oriented composite endpoint of any death, MI, and coronary revasculariza-tions were also similar.Conclusions:These results confirm good long-term safety and efficacy of the studiedbioresorbable polymer stent in this high-risk patient population.
2020
clinical trials; complex pci; coronary artery disease; drug eluting; percutaneous coronary intervention; stent; stent design/structure/coating
01 Pubblicazione su rivista::01l Trial clinico
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 / Iniguez, A.; Chevalier, B.; Richardt, G.; Neylon, A.; Jimenez, V. A.; Kornowski, R.; Carrie, D.; Moreno, R.; Barbato, E.; Serra-Penaranda, A.; Guiducci, V.; Valdes-Chavarri, M.; Yajima, J.; Wijns, W.; Saito, S.. - In: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. - ISSN 1522-1946. - 95:2(2020), pp. 175-184. [10.1002/ccd.28224]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1660252
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