Cargando…
Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents
BACKGROUND: The choice of optimal drug‐eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long‐term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus‐elut...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6915288/ https://www.ncbi.nlm.nih.gov/pubmed/31696762 http://dx.doi.org/10.1161/JAHA.119.013607 |
_version_ | 1783479981252280320 |
---|---|
author | Iglesias, Juan F. Heg, Dik Roffi, Marco Tüller, David Lanz, Jonas Rigamonti, Fabio Muller, Olivier Moarof, Igal Cook, Stéphane Weilenmann, Daniel Kaiser, Christoph Cuculi, Florim Valgimigli, Marco Jüni, Peter Windecker, Stephan Pilgrim, Thomas |
author_facet | Iglesias, Juan F. Heg, Dik Roffi, Marco Tüller, David Lanz, Jonas Rigamonti, Fabio Muller, Olivier Moarof, Igal Cook, Stéphane Weilenmann, Daniel Kaiser, Christoph Cuculi, Florim Valgimigli, Marco Jüni, Peter Windecker, Stephan Pilgrim, Thomas |
author_sort | Iglesias, Juan F. |
collection | PubMed |
description | BACKGROUND: The choice of optimal drug‐eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long‐term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus‐eluting stents (BP‐SES) versus durable polymer everolimus‐eluting stents (DP‐EES) in patients with DM. METHODS AND RESULTS: In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization) trial (NCT01443104), patients randomly assigned to ultrathin‐strut BP‐SES or thin‐strut DP‐EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM. Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP‐SES and 57 patients (25.8%) treated with DP‐EES (risk ratio, 1.23; 95% CI, 0.87–1.73 [P=0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP‐SES and 132 patients (16.8%) treated with DP‐EES (risk ratio, 0.98; 95% CI, 0.77–1.26 [P=0.90; P for interaction=0.31]). Cumulative 5‐year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP‐SES or DP‐EES. There was no interaction between diabetic status and treatment effect of BP‐SES versus DP‐EES. CONCLUSIONS: In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin‐strut BP‐SES or thin‐strut DP‐EES. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01443104. |
format | Online Article Text |
id | pubmed-6915288 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-69152882019-12-23 Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents Iglesias, Juan F. Heg, Dik Roffi, Marco Tüller, David Lanz, Jonas Rigamonti, Fabio Muller, Olivier Moarof, Igal Cook, Stéphane Weilenmann, Daniel Kaiser, Christoph Cuculi, Florim Valgimigli, Marco Jüni, Peter Windecker, Stephan Pilgrim, Thomas J Am Heart Assoc Original Research BACKGROUND: The choice of optimal drug‐eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long‐term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus‐eluting stents (BP‐SES) versus durable polymer everolimus‐eluting stents (DP‐EES) in patients with DM. METHODS AND RESULTS: In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization) trial (NCT01443104), patients randomly assigned to ultrathin‐strut BP‐SES or thin‐strut DP‐EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM. Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP‐SES and 57 patients (25.8%) treated with DP‐EES (risk ratio, 1.23; 95% CI, 0.87–1.73 [P=0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP‐SES and 132 patients (16.8%) treated with DP‐EES (risk ratio, 0.98; 95% CI, 0.77–1.26 [P=0.90; P for interaction=0.31]). Cumulative 5‐year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP‐SES or DP‐EES. There was no interaction between diabetic status and treatment effect of BP‐SES versus DP‐EES. CONCLUSIONS: In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin‐strut BP‐SES or thin‐strut DP‐EES. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01443104. John Wiley and Sons Inc. 2019-11-07 /pmc/articles/PMC6915288/ /pubmed/31696762 http://dx.doi.org/10.1161/JAHA.119.013607 Text en © 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Research Iglesias, Juan F. Heg, Dik Roffi, Marco Tüller, David Lanz, Jonas Rigamonti, Fabio Muller, Olivier Moarof, Igal Cook, Stéphane Weilenmann, Daniel Kaiser, Christoph Cuculi, Florim Valgimigli, Marco Jüni, Peter Windecker, Stephan Pilgrim, Thomas Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents |
title | Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents |
title_full | Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents |
title_fullStr | Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents |
title_full_unstemmed | Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents |
title_short | Five‐Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus‐Eluting Stents Versus Durable Polymer Everolimus‐Eluting Stents |
title_sort | five‐year outcomes in patients with diabetes mellitus treated with biodegradable polymer sirolimus‐eluting stents versus durable polymer everolimus‐eluting stents |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6915288/ https://www.ncbi.nlm.nih.gov/pubmed/31696762 http://dx.doi.org/10.1161/JAHA.119.013607 |
work_keys_str_mv | AT iglesiasjuanf fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT hegdik fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT roffimarco fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT tullerdavid fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT lanzjonas fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT rigamontifabio fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT mullerolivier fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT moarofigal fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT cookstephane fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT weilenmanndaniel fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT kaiserchristoph fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT cuculiflorim fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT valgimiglimarco fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT junipeter fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT windeckerstephan fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents AT pilgrimthomas fiveyearoutcomesinpatientswithdiabetesmellitustreatedwithbiodegradablepolymersirolimuselutingstentsversusdurablepolymereverolimuselutingstents |