Long-Term Performance of the COMBO Dual-Therapy Stent: Results from the REMEDEE Registry.
Acute Coronary Syndrome
/ diagnostic imaging
Aged
Cause of Death
Coronary Artery Disease
/ diagnostic imaging
Drug-Eluting Stents
Europe
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
/ adverse effects
Product Surveillance, Postmarketing
Prospective Studies
Prosthesis Design
Recurrence
Registries
Risk Factors
Time Factors
Treatment Outcome
Coronary artery disease
Drug eluting stent
Dual-therapy stent
Percutaneous coronary intervention
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
19
07
2019
revised:
27
08
2019
accepted:
11
09
2019
pubmed:
31
10
2019
medline:
5
11
2020
entrez:
31
10
2019
Statut:
ppublish
Résumé
Data of long-term safety and efficacy of the COMBO dual-therapy stent is lacking. REMEDEE Registry evaluated the COMBO stent and showed low clinical event rates up to 3 year. We report the clinical outcomes at 4-year follow-up of this registry. The REMEDEE Registry is a prospective, multicenter registry with minimal exclusion criteria, evaluating clinical outcomes after treatment with the COMBO stent. A 1000 patients were enrolled between June 2013 and March 2014. Target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR), at 4-year follow-up was the primary focus of this analysis. Four-year follow-up data were obtained in 97.3% of patients. TLF was present in 117 patients (11.9%). Cardiac death occurred in 45 patients (4.6%), TV-MI was observed in 25 patients (2.6%) and TLR was performed in 73 patients (7.5%). Of the 7.5% TLR at 4 years, 1.5% were beyond 2 years. Definite ST was seen in 7 patients (0.7%) and probable ST in 1 (0.1%). No definite or probable ST occurred between 3 and 4 years follow-up. At 4-year follow-up, 93.1% of patients were free of ischemic symptoms. This registry showed excellent 4-year results after COMBO stent placement, with no ST beyond 3 years.
Sections du résumé
BACKGROUND
Data of long-term safety and efficacy of the COMBO dual-therapy stent is lacking. REMEDEE Registry evaluated the COMBO stent and showed low clinical event rates up to 3 year. We report the clinical outcomes at 4-year follow-up of this registry.
METHODS
The REMEDEE Registry is a prospective, multicenter registry with minimal exclusion criteria, evaluating clinical outcomes after treatment with the COMBO stent. A 1000 patients were enrolled between June 2013 and March 2014. Target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR), at 4-year follow-up was the primary focus of this analysis.
RESULTS
Four-year follow-up data were obtained in 97.3% of patients. TLF was present in 117 patients (11.9%). Cardiac death occurred in 45 patients (4.6%), TV-MI was observed in 25 patients (2.6%) and TLR was performed in 73 patients (7.5%). Of the 7.5% TLR at 4 years, 1.5% were beyond 2 years. Definite ST was seen in 7 patients (0.7%) and probable ST in 1 (0.1%). No definite or probable ST occurred between 3 and 4 years follow-up. At 4-year follow-up, 93.1% of patients were free of ischemic symptoms.
CONCLUSION
This registry showed excellent 4-year results after COMBO stent placement, with no ST beyond 3 years.
Identifiants
pubmed: 31662276
pii: S1553-8389(19)30640-2
doi: 10.1016/j.carrev.2019.09.015
pii:
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
567-570Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2019. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of competing interest All including centers received institutional grants. Drs. Menown has received grant support from Boston Scientific and Biosensors. Dr. den Heijer has received consultant fee from Medtronic CoreValve and Direct Flow Medical. Dr. van't Hof has received grant support from The Medicines Company and grant support from Abbott. Dr. de Winter has received grant support from OrbusNeich, Abbott, AstraZeneca, Stentys, and Tryton; and consultant fee from OrbusNeich. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.