Long-term follow-up after sirolimus-coated balloon use for coronary artery disease. Final results of the Nanolutè study.
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Cardiovascular Agents
/ administration & dosage
Coated Materials, Biocompatible
Coronary Artery Disease
/ diagnostic imaging
Coronary Restenosis
/ diagnostic imaging
Equipment Design
Female
Humans
India
Male
Middle Aged
Myocardial Infarction
/ etiology
Prospective Studies
Registries
Risk Factors
Sirolimus
/ administration & dosage
Time Factors
Treatment Outcome
DCB
long-term follow-up
prospective registry
sirolimus-coated balloon
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
29
01
2020
revised:
27
02
2020
accepted:
15
03
2020
pubmed:
20
3
2020
medline:
29
6
2021
entrez:
20
3
2020
Statut:
ppublish
Résumé
To test the long-term efficacy of a sirolimus-coated balloon (SCB). Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data. All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI). A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.
Sections du résumé
OBJECTIVES
To test the long-term efficacy of a sirolimus-coated balloon (SCB).
BACKGROUND
Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data.
METHODS
All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI).
RESULTS
A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%).
CONCLUSION
The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.
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
E496-E500Informations de copyright
© 2020 Wiley Periodicals, Inc.
Références
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