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
Íñiguez-Romo, Andrés (Hospital Álvaro Cunqueiro (Vigo))
Chevalier, Bernard (Institut Cardiovasculaire Paris Sud)
Richardt, Gert (Segeberger Kliniken)
Neylon, Antoinette (SAOLTA Health Care Group, Galway University Hospital and NUI)
Jiménez, Victor A. (Hospital Álvaro Cunqueiro (Vigo))
Kornowski, Ran (Rabin Medical Centre, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University)
Carrie, Didier (Rangueil University Hospital)
Moreno, Raul (Hospital Universitario La Paz (Madrid))
Barbato, Emanuele (University of Naples Federico II)
Serra-Peñaranda, Antoni (Institut d'Investigació Biomèdica Sant Pau)
Guiducci, Vincenzo (Interventional Cardiology Unit, S. Maria Nuova Hospital)
Valdés-Chávarri, Mariano (Hospital Clínico Universitario Virgen de la Arrixaca (El Palmar, Múrcia))
Yajima, Junji (The Cardiovascular Institute (Tòquio, Japó))
Wijns, William (The Lambe Institute)
Saito, Shigeru (Shonan Kamakura General Hospital)
Universitat Autònoma de Barcelona

Fecha:	2019
Resumen:	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. 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. 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. 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. These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Clinical trials ; Complex PCI ; Coronary artery disease ; Drug eluting ; Percutaneous coronary intervention, stent ; Stent design/structure/coating
Publicado en:	Catheterization and Cardiovascular Interventions, Vol. 95 (april 2019) , p. 175-184, ISSN 1522-726X

DOI: 10.1002/ccd.28224
PMID: 31033154

10 p, 1.4 MB

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