Five-Year Results of the Bioflow-III Registry: Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent.
Absorbable Implants
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Cardiovascular Agents
/ administration & dosage
Chronic Disease
Coronary Artery Disease
/ diagnostic imaging
Coronary Occlusion
/ diagnostic imaging
Coronary Thrombosis
/ etiology
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Myocardial Infarction
/ diagnostic imaging
Polyesters
/ chemistry
Prospective Studies
Prosthesis Design
Recurrence
Registries
Risk Factors
Sirolimus
/ administration & dosage
Time Factors
Treatment Outcome
Biodegradable polymer
Coronary artery stenosis
Diabetes
Drug-eluting stent
Hybrid stent
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
10
12
2018
revised:
18
02
2019
accepted:
06
03
2019
pubmed:
30
3
2019
medline:
26
8
2020
entrez:
30
3
2019
Statut:
ppublish
Résumé
We aimed to assess long-term safety and performance of the Orsiro sirolimus-eluting coronary stent with biodegradable polymer in a large unselected population and in pre-specified subgroups. BIOFLOW-III is a prospective, multicenter, international, observational registry with follow-up visits scheduled at 6 and 12 months, and at 3 and 5 years (NCT01553526). 1356 patients with 1738 lesions were enrolled. Of those, 392 (28.9%) declined to participate in the study extension from 18 months to 5 years, 37 (2.7%) withdrew consent, and 89 (6.6%) were lost to follow-up. At 5-years, Kaplan-Meier estimates of target lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, coronary artery bypass grafting and clinically driven target lesion revascularization was 10.0% [95% confidence interval (CI): 8.4; 12.0] in the overall population, and 14.0% [95% CI: 10.5; 18.6], 10.3% [95% CI: 7.8; 13.5], 1.8% [95% CI: 0.3; 12.0], and 11.3% [95% CI: 8.5; 15.1] in the pre-defined risk groups of patients with diabetes mellitus, small vessels ≤2.75 mm, chronic total occlusion, and acute myocardial infarction. Definite stent thrombosis was observed in 0.3% [95% CI: 0.1; 0.9] of patients. These long-term outcomes provide further evidence on the safety and performance of a sirolimus-eluting biodegradable polymer stent within daily clinical practice. The very low definite stent thrombosis rate affirms biodegradable polymer safety and performance.
Identifiants
pubmed: 30922870
pii: S1553-8389(19)30166-6
doi: 10.1016/j.carrev.2019.03.004
pii:
doi:
Substances chimiques
Cardiovascular Agents
0
Polyesters
0
poly(lactide)
459TN2L5F5
Sirolimus
W36ZG6FT64
Banques de données
ClinicalTrials.gov
['NCT01553526']
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
63-69Informations de copyright
Copyright © 2019. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Conflict of interest statement JW reports personal fees and non-financial support from Biotronik, and personal fees from Bayer. Boehringer Ingelheim and Daiichi-Sankyo, JB reports personal fees and grants from Medtronic, Biotronik, and St. Jude, AE reports grants and personal fees from Abbott Vascular and Boston Scientific and personal fees from Biotronik and Biosensors, and OF and GF report personal fees from Biotronik. All other authors have no conflicts of interest to declare.