A prospective trial of a novel low-dose paclitaxel-coated balloon therapy in patients with restenosis in drug-eluting coronary stents Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-stent REstenosis 3A (ISAR-DESIRE 3A).
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Cardiovascular Agents
/ adverse effects
Constriction, Pathologic
/ chemically induced
Coronary Angiography
/ adverse effects
Coronary Restenosis
/ diagnostic imaging
Drug-Eluting Stents
/ adverse effects
Humans
Middle Aged
Paclitaxel
/ adverse effects
Prospective Studies
Stents
/ adverse effects
Treatment Outcome
balloon angioplasty
drug coated balloon
drug eluting stent
in-stent restenosis
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:
02 2022
02 2022
Historique:
revised:
08
10
2021
received:
20
04
2021
accepted:
19
10
2021
pubmed:
19
11
2021
medline:
8
4
2022
entrez:
18
11
2021
Statut:
ppublish
Résumé
We investigated the clinical efficacy of a paclitaxel-coated balloon (PCB) with a novel matrix coating and reduced drug concentration in comparison with a widely used PCB with iopromide excipient. We prospectively enrolled patients with restenosis in drug-eluting stents. All patients were treated with a novel low-dose PCB with citrate-based excipient (Agent PCB). Angiographic follow-up was scheduled at 6-8 months. Outcomes were compared against those of patients treated with iopromide excipient PCB (SeQuent Please PCB) enrolled in a trial with identical inclusion and exclusion criteria. The primary endpoint was percent diameter stenosis (%DS) at follow-up angiography. The primary hypothesis was that the investigational device would be non-inferior to the control device (ClinicalTrials.gov Identifier: NCT02367495). One hundred twenty-five patients with 151 lesions were enrolled. Mean age was 68.1 ± 10.2 years, 40.8% had diabetes mellitus and 80.1% had focal morphology in-stent restenosis. Follow-up angiography data at 6-8 months was available for 102 (81.6%) patients. The Agent PCB was non-inferior to the SeQuent Please PCB in terms of the primary endpoint (38.9 ± 17.5 vs. 38.1 ± 21.5%; p In patients with DES restenosis, angioplasty with a novel PCB with citrate-based excipient was non-inferior to PCB with iopromide excipient in terms of angiographic outcome.
Substances chimiques
Cardiovascular Agents
0
Paclitaxel
P88XT4IS4D
Banques de données
ClinicalTrials.gov
['NCT02367495']
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
754-762Subventions
Organisme : Boston Scientific Corporation
ID : Partial funding
Informations de copyright
© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
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