Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study
Abstract Background Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention p...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-03-01
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| Series: | Cardiovascular Diabetology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12933-019-0827-z |
| _version_ | 1811215014918356992 |
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| author | T. M. Hommels R. S. Hermanides S. Rasoul B. Berta A. J. J. IJsselmuiden G. A. J. Jessurun E. Benit B. Pereira G. De Luca E. Kedhi |
| author_facet | T. M. Hommels R. S. Hermanides S. Rasoul B. Berta A. J. J. IJsselmuiden G. A. J. Jessurun E. Benit B. Pereira G. De Luca E. Kedhi |
| author_sort | T. M. Hommels |
| collection | DOAJ |
| description | Abstract Background Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. Methods The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). Results Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. Conclusion EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered |
| first_indexed | 2024-04-12T06:14:06Z |
| format | Article |
| id | doaj.art-b6a1007823124237b68fd3352dbbb638 |
| institution | Directory Open Access Journal |
| issn | 1475-2840 |
| language | English |
| last_indexed | 2024-04-12T06:14:06Z |
| publishDate | 2019-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Cardiovascular Diabetology |
| spelling | doaj.art-b6a1007823124237b68fd3352dbbb6382022-12-22T03:44:34ZengBMCCardiovascular Diabetology1475-28402019-03-0118111010.1186/s12933-019-0827-zEverolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux studyT. M. Hommels0R. S. Hermanides1S. Rasoul2B. Berta3A. J. J. IJsselmuiden4G. A. J. Jessurun5E. Benit6B. Pereira7G. De Luca8E. Kedhi9Isala Klinieken, Isala HartcentrumIsala Klinieken, Isala HartcentrumZuyderland Medisch CentrumIsala Klinieken, Isala HartcentrumAlbert Schweitzer ZiekenhuisScheper ZiekenhuisVirga Jesse ZiekenhuisInstitut National de Chirurgie Cardiaque et de Cardiologie InterventionnelleIsala Klinieken, Isala HartcentrumIsala Klinieken, Isala HartcentrumAbstract Background Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. Methods The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). Results Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. Conclusion EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registeredhttp://link.springer.com/article/10.1186/s12933-019-0827-zBioresorbable scaffoldDiabetes mellitusCoronary artery diseasePercutaneous coronary interventionScaffold thrombosis |
| spellingShingle | T. M. Hommels R. S. Hermanides S. Rasoul B. Berta A. J. J. IJsselmuiden G. A. J. Jessurun E. Benit B. Pereira G. De Luca E. Kedhi Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study Cardiovascular Diabetology Bioresorbable scaffold Diabetes mellitus Coronary artery disease Percutaneous coronary intervention Scaffold thrombosis |
| title | Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study |
| title_full | Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study |
| title_fullStr | Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study |
| title_full_unstemmed | Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study |
| title_short | Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study |
| title_sort | everolimus eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus the midterm follow up of the prospective absorb dm benelux study |
| topic | Bioresorbable scaffold Diabetes mellitus Coronary artery disease Percutaneous coronary intervention Scaffold thrombosis |
| url | http://link.springer.com/article/10.1186/s12933-019-0827-z |
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