Efficacy of drug-coated balloon angioplasty in early versus late occurring drug-eluting stent restenosis: A pooled analysis from the randomized ISAR DESIRE 3 and DESIRE 4 trials.
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Coated Materials, Biocompatible
Coronary Artery Disease
/ diagnostic imaging
Coronary Restenosis
/ diagnostic imaging
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
/ adverse effects
Randomized Controlled Trials as Topic
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
coronary artery disease
drug-coated/eluting balloon
drug-eluting stent
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:
11 2020
11 2020
Historique:
received:
23
07
2019
revised:
21
10
2019
accepted:
21
11
2019
pubmed:
4
12
2019
medline:
29
6
2021
entrez:
3
12
2019
Statut:
ppublish
Résumé
Whether there exist differences concerning clinical outcomes between patients presenting with early versus late DES-ISR undergoing treatment with drug-coated balloons (DCB) remains a scientific knowledge gap. This is a pooled analysis including patients with DES-ISR assigned to treatment with DCB in the setting of the ISAR DESIRE 3 and 4 trials. Clinical outcomes were evaluated according to time of occurrence of ISR after DES implantation, in patients presenting with early (≤12 months) versus late DES-ISR (>12 months) undergoing treatment with DCB. The primary endpoint of this analysis was major adverse cardiac event (MACE), defined as the combined incidence of death, myocardial infarction and target lesion revascularization (TLR) at 12 months after DCB treatment. Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment. This analysis included 352 patients, 199 patients presented with early-ISR, 153 patients with late-ISR. Concerning the primary endpoint, patients with early-DES-ISR as compared those with late-DES-ISR showed significant higher risk (25.9% vs. 17.0%; p = .04). In a multivariate analysis including diabetic status, clinical presentation, previous coronary bypass graft and diameter stenosis after DCB-treatment, the adjusted hazard ratio showed significant higher risk for MACE of early-DES-ISR as compared to late-DES-ISR (HR Clinical outcome at 12 months after treatment of DES-ISR with DCB, showed significant higher clinical event rates in patients presenting with early DES restenosis, as compared with patients presenting with late DES restenosis.
Sections du résumé
BACKGROUND
Whether there exist differences concerning clinical outcomes between patients presenting with early versus late DES-ISR undergoing treatment with drug-coated balloons (DCB) remains a scientific knowledge gap.
METHODS
This is a pooled analysis including patients with DES-ISR assigned to treatment with DCB in the setting of the ISAR DESIRE 3 and 4 trials. Clinical outcomes were evaluated according to time of occurrence of ISR after DES implantation, in patients presenting with early (≤12 months) versus late DES-ISR (>12 months) undergoing treatment with DCB. The primary endpoint of this analysis was major adverse cardiac event (MACE), defined as the combined incidence of death, myocardial infarction and target lesion revascularization (TLR) at 12 months after DCB treatment. Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment.
RESULTS
This analysis included 352 patients, 199 patients presented with early-ISR, 153 patients with late-ISR. Concerning the primary endpoint, patients with early-DES-ISR as compared those with late-DES-ISR showed significant higher risk (25.9% vs. 17.0%; p = .04). In a multivariate analysis including diabetic status, clinical presentation, previous coronary bypass graft and diameter stenosis after DCB-treatment, the adjusted hazard ratio showed significant higher risk for MACE of early-DES-ISR as compared to late-DES-ISR (HR
CONCLUSION
Clinical outcome at 12 months after treatment of DES-ISR with DCB, showed significant higher clinical event rates in patients presenting with early DES restenosis, as compared with patients presenting with late DES restenosis.
Substances chimiques
Coated Materials, Biocompatible
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1008-1015Informations de copyright
© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.
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