Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS
Abstract Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus...
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| Format: | Article |
| Language: | English |
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BMC
2020-10-01
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| Series: | Cardiovascular Diabetology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12933-020-01116-2 |
| _version_ | 1819207905669283840 |
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| author | T. M. Hommels R. S. Hermanides B. Berta E. Fabris G. De Luca E. H. Ploumen C. von Birgelen E. Kedhi |
| author_facet | T. M. Hommels R. S. Hermanides B. Berta E. Fabris G. De Luca E. H. Ploumen C. von Birgelen E. Kedhi |
| author_sort | T. M. Hommels |
| collection | DOAJ |
| description | Abstract Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES. Methods We performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST). Results A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77–2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70–2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99). Conclusion In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES. |
| first_indexed | 2024-12-23T05:30:55Z |
| format | Article |
| id | doaj.art-15ac810077b443b492d1c4aa9d883688 |
| institution | Directory Open Access Journal |
| issn | 1475-2840 |
| language | English |
| last_indexed | 2024-12-23T05:30:55Z |
| publishDate | 2020-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Cardiovascular Diabetology |
| spelling | doaj.art-15ac810077b443b492d1c4aa9d8836882022-12-21T17:58:29ZengBMCCardiovascular Diabetology1475-28402020-10-0119111010.1186/s12933-020-01116-2Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERST. M. Hommels0R. S. Hermanides1B. Berta2E. Fabris3G. De Luca4E. H. Ploumen5C. von Birgelen6E. Kedhi7Isala HospitalIsala HospitalIsala HospitalCardiovascular Department, University of TriesteAOU Maggiore della Carità, Eastern Piedmont UniversityMedisch Spectrum Twente, Thoraxcentrum & University of TwenteMedisch Spectrum Twente, Thoraxcentrum & University of TwenteDepartment of Cardiology, Hôpital Erasme Université Libre de BruxellesAbstract Background Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus. Aim To evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES. Methods We performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST). Results A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77–2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70–2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99). Conclusion In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.http://link.springer.com/article/10.1186/s12933-020-01116-2Bioresorbable scaffoldsDrug-eluting stentsDiabetes mellitusCoronary artery diseasePercutaneous coronary interventionDevice thrombosis |
| spellingShingle | T. M. Hommels R. S. Hermanides B. Berta E. Fabris G. De Luca E. H. Ploumen C. von Birgelen E. Kedhi Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS Cardiovascular Diabetology Bioresorbable scaffolds Drug-eluting stents Diabetes mellitus Coronary artery disease Percutaneous coronary intervention Device thrombosis |
| title | Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS |
| title_full | Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS |
| title_fullStr | Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS |
| title_full_unstemmed | Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS |
| title_short | Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS |
| title_sort | everolimus eluting bioresorbable scaffolds and metallic stents in diabetic patients a patient level pooled analysis of the prospective absorb dm benelux study twente and dutch peers |
| topic | Bioresorbable scaffolds Drug-eluting stents Diabetes mellitus Coronary artery disease Percutaneous coronary intervention Device thrombosis |
| url | http://link.springer.com/article/10.1186/s12933-020-01116-2 |
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