Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent for Coronary Revascularization in Routine Clinical Practice.
Absorbable Implants
Aged
Aged, 80 and over
Cardiovascular Agents
/ administration & dosage
Coronary Artery Disease
/ diagnostic imaging
Coronary Thrombosis
/ etiology
Drug-Eluting Stents
Everolimus
/ administration & dosage
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
/ adverse effects
Polymers
/ chemistry
Prosthesis Design
Registries
Risk Assessment
Risk Factors
Switzerland
Time Factors
Treatment Outcome
coronary artery disease
drug-eluting stent
restenosis
stent thrombosis
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
09 09 2019
09 09 2019
Historique:
received:
16
01
2019
revised:
17
04
2019
accepted:
26
04
2019
pubmed:
20
8
2019
medline:
8
9
2020
entrez:
19
8
2019
Statut:
ppublish
Résumé
The aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES) (Synergy, Boston Scientific, Marlborough, Massachusetts) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES) (XIENCE, Abbott Vascular, Abbott Park, Illinois) in an all-comers population. BP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk. Among 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months. The device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%; p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%; p = 0.53), and target lesion revascularization (3.0% vs. 2.5%; p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22). In this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291).
Sections du résumé
OBJECTIVES
The aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES) (Synergy, Boston Scientific, Marlborough, Massachusetts) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES) (XIENCE, Abbott Vascular, Abbott Park, Illinois) in an all-comers population.
BACKGROUND
BP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk.
METHODS
Among 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months.
RESULTS
The device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%; p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%; p = 0.53), and target lesion revascularization (3.0% vs. 2.5%; p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22).
CONCLUSIONS
In this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291).
Identifiants
pubmed: 31422088
pii: S1936-8798(19)31086-6
doi: 10.1016/j.jcin.2019.04.046
pii:
doi:
Substances chimiques
Cardiovascular Agents
0
Polymers
0
Everolimus
9HW64Q8G6G
Banques de données
ClinicalTrials.gov
['NCT02241291']
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1665-1675Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.