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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
- Source :
- Catheterization and Cardiovascular Interventions, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname
- Publication Year :
- 2019
- Publisher :
- John Wiley & Sons, Inc., 2019.
-
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.
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1522726X and 15221946
- Volume :
- 95
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Catheterization and Cardiovascular Interventions
- Accession number :
- edsair.doi.dedup.....8c776a63ee25e05f9a8680a34dc60295