In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease
Objectives. The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. B...
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| Format: | Article |
| Language: | English |
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Wiley
2023-01-01
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| Series: | Journal of Interventional Cardiology |
| Online Access: | http://dx.doi.org/10.1155/2023/8907315 |
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| author | Quentin Landolff Marine Quillot Fabien Picard Patrick Henry Georgios Sideris Olivier Bizeau Christophe Piot Bernard Jouve Jérôme Rischner Mourad Mejri Claude Charmasson Raphael Lasserre Hervé Pouliquen Thierry Joseph Jacques Monsegu Bernard Karsenty Victoria Martin Yuste Nicolas Richet Guy Lapeyre Fabrizio Beverelli Farzin Beygui René Koning |
| author_facet | Quentin Landolff Marine Quillot Fabien Picard Patrick Henry Georgios Sideris Olivier Bizeau Christophe Piot Bernard Jouve Jérôme Rischner Mourad Mejri Claude Charmasson Raphael Lasserre Hervé Pouliquen Thierry Joseph Jacques Monsegu Bernard Karsenty Victoria Martin Yuste Nicolas Richet Guy Lapeyre Fabrizio Beverelli Farzin Beygui René Koning |
| author_sort | Quentin Landolff |
| collection | DOAJ |
| description | Objectives. The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background. The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and “all-comers” observational studies. Methods. For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results. 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions. The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715. |
| format | Article |
| id | doaj-art-e318ea00545a4464802b0bd6859d0a26 |
| institution | DOAJ |
| issn | 1540-8183 |
| language | English |
| publishDate | 2023-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Interventional Cardiology |
| spelling | doaj-art-e318ea00545a4464802b0bd6859d0a262025-08-20T03:21:07ZengWileyJournal of Interventional Cardiology1540-81832023-01-01202310.1155/2023/8907315In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery DiseaseQuentin Landolff0Marine Quillot1Fabien Picard2Patrick Henry3Georgios Sideris4Olivier Bizeau5Christophe Piot6Bernard Jouve7Jérôme Rischner8Mourad Mejri9Claude Charmasson10Raphael Lasserre11Hervé Pouliquen12Thierry Joseph13Jacques Monsegu14Bernard Karsenty15Victoria Martin Yuste16Nicolas Richet17Guy Lapeyre18Fabrizio Beverelli19Farzin Beygui20René Koning21Department of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyObjectives. The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background. The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and “all-comers” observational studies. Methods. For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results. 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions. The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.http://dx.doi.org/10.1155/2023/8907315 |
| spellingShingle | Quentin Landolff Marine Quillot Fabien Picard Patrick Henry Georgios Sideris Olivier Bizeau Christophe Piot Bernard Jouve Jérôme Rischner Mourad Mejri Claude Charmasson Raphael Lasserre Hervé Pouliquen Thierry Joseph Jacques Monsegu Bernard Karsenty Victoria Martin Yuste Nicolas Richet Guy Lapeyre Fabrizio Beverelli Farzin Beygui René Koning In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease Journal of Interventional Cardiology |
| title | In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease |
| title_full | In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease |
| title_fullStr | In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease |
| title_full_unstemmed | In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease |
| title_short | In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease |
| title_sort | in hospital and 1 year clinical results from the french registry using polymer free sirolimus eluting stents in acute coronary syndrome and stable coronary artery disease |
| url | http://dx.doi.org/10.1155/2023/8907315 |
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