A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry.
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Cardiac Catheters
Cardiovascular Agents
/ administration & dosage
Coated Materials, Biocompatible
Coronary Artery Disease
/ diagnostic imaging
Equipment Design
Feasibility Studies
Female
Humans
India
Male
Middle Aged
Myocardial Infarction
/ mortality
Prospective Studies
Registries
Retreatment
Risk Factors
Sirolimus
/ administration & dosage
Time Factors
Treatment Outcome
CAD
PTCA
SCB
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:
03 2019
03 2019
Historique:
received:
26
01
2018
revised:
04
06
2018
accepted:
04
06
2018
pubmed:
10
9
2018
medline:
12
5
2020
entrez:
10
9
2018
Statut:
ppublish
Résumé
The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions. All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction. A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1). The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.
Sections du résumé
BACKGROUND
The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.
METHODS
All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction.
RESULTS
A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1).
CONCLUSION
The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.
Identifiants
pubmed: 30196029
pii: S1553-8389(18)30246-X
doi: 10.1016/j.carrev.2018.06.003
pii:
doi:
Substances chimiques
Cardiovascular Agents
0
Coated Materials, Biocompatible
0
Sirolimus
W36ZG6FT64
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
235-240Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2018 Elsevier Inc. All rights reserved.