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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Emanuele Barbato, Gert Richardt, Didier Carrié, Bernard Chevalier, William Wijns, Antoinette Neylon, Andrés Iñiguez, Mariano Valdés-Chávarri, Raúl Moreno, Shigeru Saito, Vincenzo Guiducci, Century Ii study investigators, Victor Alfonso Jimenez, Ran Kornowski, Antoni Serra-Peñaranda, Junji Yajima, 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., and Saito, S.
- Subjects
Target lesion ,Male ,Time Factors ,percutaneous coronary intervention, stent ,Polymers ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary artery disease ,Original Studies ,law.invention ,0302 clinical medicine ,Clinical trials ,Randomized controlled trial ,Japan ,law ,Risk Factors ,Absorbable Implants ,Clinical endpoint ,Medicine ,Single-Blind Method ,030212 general & internal medicine ,Myocardial infarction ,Prospective Studies ,Drug eluting ,coating ,clinical trial ,Drug-Eluting Stents ,General Medicine ,Middle Aged ,drug eluting ,Europe ,Treatment Outcome ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Complex PCI ,Prosthesis Design ,03 medical and health sciences ,Percutaneous Coronary Intervention ,Internal medicine ,Multicenter trial ,complex PCI ,Republic of Korea ,Humans ,Radiology, Nuclear Medicine and imaging ,structure ,Everolimus ,Aged ,Sirolimus ,clinical trials ,business.industry ,Stent design/structure/coating ,percutaneous coronary intervention ,stent design ,Coronary Stenosis ,Stent ,Percutaneous coronary intervention, stent ,Cardiovascular Agents ,medicine.disease ,Clinical trial ,stent design/structure/coating ,stent ,business - Abstract
ObjectivesTo 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. BackgroundThe 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. MethodsAmong 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 9months. ResultsIn 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. ConclusionsThese results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.
- Published
- 2019