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Comparison of Zotarolimus- and Everolimus-Eluting Coronary Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial
BACKGROUND—: Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE a...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4495878/ https://www.ncbi.nlm.nih.gov/pubmed/26047993 http://dx.doi.org/10.1161/CIRCINTERVENTIONS.114.002230 |
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author | Iqbal, Javaid Serruys, Patrick W. Silber, Sigmund Kelbaek, Henning Richardt, Gert Morel, Marie-Angele Negoita, Manuela Buszman, Pawel E. Windecker, Stephan |
author_facet | Iqbal, Javaid Serruys, Patrick W. Silber, Sigmund Kelbaek, Henning Richardt, Gert Morel, Marie-Angele Negoita, Manuela Buszman, Pawel E. Windecker, Stephan |
author_sort | Iqbal, Javaid |
collection | PubMed |
description | BACKGROUND—: Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial. METHODS AND RESULTS—: RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P=0.12). CONCLUSIONS—: At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria. CLINICAL TRIAL REGISTRATION—: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00617084. |
format | Online Article Text |
id | pubmed-4495878 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-44958782015-07-17 Comparison of Zotarolimus- and Everolimus-Eluting Coronary Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial Iqbal, Javaid Serruys, Patrick W. Silber, Sigmund Kelbaek, Henning Richardt, Gert Morel, Marie-Angele Negoita, Manuela Buszman, Pawel E. Windecker, Stephan Circ Cardiovasc Interv Original Articles BACKGROUND—: Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial. METHODS AND RESULTS—: RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P=0.12). CONCLUSIONS—: At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria. CLINICAL TRIAL REGISTRATION—: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00617084. Lippincott Williams & Wilkins 2015-06 2015-06-16 /pmc/articles/PMC4495878/ /pubmed/26047993 http://dx.doi.org/10.1161/CIRCINTERVENTIONS.114.002230 Text en © 2015 The Authors. Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis (https://creativecommons.org/licenses/by-nc-nd/3.0/) License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made. |
spellingShingle | Original Articles Iqbal, Javaid Serruys, Patrick W. Silber, Sigmund Kelbaek, Henning Richardt, Gert Morel, Marie-Angele Negoita, Manuela Buszman, Pawel E. Windecker, Stephan Comparison of Zotarolimus- and Everolimus-Eluting Coronary Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial |
title | Comparison of Zotarolimus- and Everolimus-Eluting Coronary
Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial |
title_full | Comparison of Zotarolimus- and Everolimus-Eluting Coronary
Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial |
title_fullStr | Comparison of Zotarolimus- and Everolimus-Eluting Coronary
Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial |
title_full_unstemmed | Comparison of Zotarolimus- and Everolimus-Eluting Coronary
Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial |
title_short | Comparison of Zotarolimus- and Everolimus-Eluting Coronary
Stents: Final 5-Year Report of the RESOLUTE All-Comers Trial |
title_sort | comparison of zotarolimus- and everolimus-eluting coronary
stents: final 5-year report of the resolute all-comers trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4495878/ https://www.ncbi.nlm.nih.gov/pubmed/26047993 http://dx.doi.org/10.1161/CIRCINTERVENTIONS.114.002230 |
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