Long-term (5-year) clinical evaluation of the Resolute zotarolimus-eluting coronary stent: The RESOLUTE US clinical trial.
Aged
Cardiovascular Agents
/ administration & dosage
Coronary Artery Disease
/ diagnostic imaging
Coronary Thrombosis
/ etiology
Drug-Eluting Stents
Dual Anti-Platelet Therapy
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
/ adverse effects
Prospective Studies
Recurrence
Risk Assessment
Risk Factors
Sirolimus
/ administration & dosage
Time Factors
Treatment Outcome
United States
Resolute US
Resolute zotarolimus-eluting stent
drug-eluting stent
percutaneous coronary interventions
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:
01 05 2020
01 05 2020
Historique:
received:
23
04
2019
revised:
26
06
2019
accepted:
27
06
2019
pubmed:
14
7
2019
medline:
15
12
2020
entrez:
14
7
2019
Statut:
ppublish
Résumé
To assess the long-term safety and efficacy of the Resolute zotarolimus-eluting stent (R-ZES). The R-ZES has been associated with low rates of adverse events over short-intermediate term follow-up. However, reliable assessment of the safety and efficacy of any implanted device requires long-term evaluation. The RESOLUTE US trial was a prospective, observational study conducted at 116 U.S. sites and enrolled patients with de novo coronary lesions. Patients were followed clinically for 5 years with independent event adjudication and data monitoring. A total of 1,402 patients (1,573 lesions) were enrolled; 34% had diabetes mellitus and 75% had ACC type B2/C lesions. The 5-year rate of target lesion failure (TLF) was 12.3%, target lesion revascularization was 6.5%, target vessel myocardial infarction was 3.2%, and cardiac death was 4.1%. Dual antiplatelet therapy usage was 94% at 1 year and 47% at 5 years, with a 0.1% and 0.5% respective incidence of definite or probable stent thrombosis. The 5-year rate of TLF was 16.9% among patients with diabetes mellitus and 14.7% in patients with at least one small (≤2.5 mm) vessel treated. Covariates independently associated with 5-year TLF in multivariable analysis included diabetes mellitus (odds ratio [OR] 1.89, p < .001), prior coronary artery bypass grafting (OR 2.28, p < .001), prior myocardial infarction (OR 1.85, p = .002), and smaller reference vessel diameter (OR 1.75, p = .004). Results from the fully adjudicated and monitored RESOLUTE US trial demonstrate long-term 5-year safety and efficacy of the R-ZES stent among a relatively low-risk population of patients, including a 0.5% rate of stent thrombosis at 5 years.
Sections du résumé
OBJECTIVES
To assess the long-term safety and efficacy of the Resolute zotarolimus-eluting stent (R-ZES).
BACKGROUND
The R-ZES has been associated with low rates of adverse events over short-intermediate term follow-up. However, reliable assessment of the safety and efficacy of any implanted device requires long-term evaluation.
METHODS
The RESOLUTE US trial was a prospective, observational study conducted at 116 U.S. sites and enrolled patients with de novo coronary lesions. Patients were followed clinically for 5 years with independent event adjudication and data monitoring.
RESULTS
A total of 1,402 patients (1,573 lesions) were enrolled; 34% had diabetes mellitus and 75% had ACC type B2/C lesions. The 5-year rate of target lesion failure (TLF) was 12.3%, target lesion revascularization was 6.5%, target vessel myocardial infarction was 3.2%, and cardiac death was 4.1%. Dual antiplatelet therapy usage was 94% at 1 year and 47% at 5 years, with a 0.1% and 0.5% respective incidence of definite or probable stent thrombosis. The 5-year rate of TLF was 16.9% among patients with diabetes mellitus and 14.7% in patients with at least one small (≤2.5 mm) vessel treated. Covariates independently associated with 5-year TLF in multivariable analysis included diabetes mellitus (odds ratio [OR] 1.89, p < .001), prior coronary artery bypass grafting (OR 2.28, p < .001), prior myocardial infarction (OR 1.85, p = .002), and smaller reference vessel diameter (OR 1.75, p = .004).
CONCLUSIONS
Results from the fully adjudicated and monitored RESOLUTE US trial demonstrate long-term 5-year safety and efficacy of the R-ZES stent among a relatively low-risk population of patients, including a 0.5% rate of stent thrombosis at 5 years.
Substances chimiques
Cardiovascular Agents
0
zotarolimus
H4GXR80IZE
Sirolimus
W36ZG6FT64
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1067-1073Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
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