1. 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.
- Author
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Iñiguez A, Chevalier B, Richardt G, Neylon A, Jiménez VA, Kornowski R, Carrie D, Moreno R, Barbato E, Serra-Peñaranda A, Guiducci V, Valdés-Chávarri M, Yajima J, Wijns W, and Saito S
- Subjects
- Aged, Cardiovascular Agents adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Artery Disease physiopathology, Coronary Stenosis diagnostic imaging, Coronary Stenosis mortality, Coronary Stenosis physiopathology, Europe, Everolimus adverse effects, Female, Humans, Japan, Male, Middle Aged, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Prospective Studies, Prosthesis Design, Republic of Korea, Risk Factors, Single-Blind Method, Sirolimus adverse effects, Time Factors, Treatment Outcome, Absorbable Implants, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Coronary Stenosis therapy, Drug-Eluting Stents, Everolimus administration & dosage, Percutaneous Coronary Intervention instrumentation, Polymers chemistry, Sirolimus administration & dosage
- 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., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)
- Published
- 2020
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