Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon.
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Cardiac Catheters
Cardiovascular Agents
/ administration & dosage
Coated Materials, Biocompatible
Coronary Angiography
Coronary Restenosis
/ diagnostic imaging
Female
Humans
Malaysia
Male
Middle Aged
Paclitaxel
/ administration & dosage
Percutaneous Coronary Intervention
/ adverse effects
Prospective Studies
Sirolimus
/ administration & dosage
Stents
Time Factors
Treatment Outcome
coronary in-stent restenosis
paclitaxel-coated balloon
sirolimus-coated balloon
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
25 Mar 2019
25 Mar 2019
Historique:
received:
17
09
2018
revised:
18
11
2018
accepted:
27
11
2018
entrez:
23
3
2019
pubmed:
23
3
2019
medline:
19
5
2020
Statut:
ppublish
Résumé
The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR. Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups. This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318).
Sections du résumé
OBJECTIVES
OBJECTIVE
The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB).
BACKGROUND
BACKGROUND
Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR.
METHODS
METHODS
Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm
RESULTS
RESULTS
Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups.
CONCLUSIONS
CONCLUSIONS
This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318).
Identifiants
pubmed: 30898253
pii: S1936-8798(18)32395-1
doi: 10.1016/j.jcin.2018.11.040
pii:
doi:
Substances chimiques
Cardiovascular Agents
0
Coated Materials, Biocompatible
0
Paclitaxel
P88XT4IS4D
Sirolimus
W36ZG6FT64
Banques de données
ClinicalTrials.gov
['NCT02996318']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
558-566Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.