Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study.
Aftercare
/ methods
Angioplasty, Balloon, Coronary
/ adverse effects
Antineoplastic Agents, Phytogenic
/ pharmacology
Coronary Angiography
/ methods
Coronary Artery Disease
/ epidemiology
Coronary Restenosis
/ diagnosis
Drug-Eluting Stents
Female
Humans
Italy
/ epidemiology
Male
Outcome and Process Assessment, Health Care
Paclitaxel
/ pharmacology
Percutaneous Coronary Intervention
/ adverse effects
Registries
Reoperation
/ instrumentation
Time
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 06 2021
01 06 2021
Historique:
entrez:
26
4
2021
pubmed:
27
4
2021
medline:
28
12
2021
Statut:
ppublish
Résumé
Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).
Identifiants
pubmed: 33896930
doi: 10.2459/JCM.0000000000001127
pii: 01244665-202106000-00006
doi:
Substances chimiques
Antineoplastic Agents, Phytogenic
0
Paclitaxel
P88XT4IS4D
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
469-477Informations de copyright
Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.
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