Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry.
Aged
Angioplasty, Balloon, Coronary
/ instrumentation
Coated Materials, Biocompatible
Coronary Angiography
Coronary Artery Disease
/ diagnosis
Drug-Eluting Stents
Female
Follow-Up Studies
Humans
Immunosuppressive Agents
/ pharmacology
Male
Prospective Studies
Registries
Sirolimus
/ pharmacology
Time Factors
Treatment Outcome
Journal
Journal of cardiovascular medicine (Hagerstown, Md.)
ISSN: 1558-2035
Titre abrégé: J Cardiovasc Med (Hagerstown)
Pays: United States
ID NLM: 101259752
Informations de publication
Date de publication:
01 02 2021
01 02 2021
Historique:
pubmed:
3
8
2020
medline:
15
12
2021
entrez:
3
8
2020
Statut:
ppublish
Résumé
The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.
Identifiants
pubmed: 32740442
pii: 01244665-202102000-00004
doi: 10.2459/JCM.0000000000001070
doi:
Substances chimiques
Coated Materials, Biocompatible
0
Immunosuppressive Agents
0
Sirolimus
W36ZG6FT64
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
94-100Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.
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