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Long‐term (5‐year) clinical evaluation of the Resolute zotarolimus‐eluting coronary stent: The RESOLUTE US clinical trial
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...
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Published in: | Catheterization and cardiovascular interventions 2020-05, Vol.95 (6), p.1067-1073 |
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Main Authors: | , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | 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 |
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ISSN: | 1522-1946 1522-726X |
DOI: | 10.1002/ccd.28392 |