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

Autor: R. S. Hermanides, Eline H. Ploumen, Balázs Berta, Enrico Fabris, T. M. Hommels, Elvin Kedhi, G. De Luca, C. von Birgelen
Přispěvatelé: Health Technology & Services Research, Hommels, T M, Hermanides, R S, Berta, B, Fabris, E, De Luca, G, Ploumen, E H, von Birgelen, C, Kedhi, E
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Bioresorbable scaffold
Male
lcsh:Diseases of the circulatory (Cardiovascular) system
Time Factors
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
030204 cardiovascular system & hematology
Coronary artery disease
Percutaneous coronary intervention
0302 clinical medicine
Diabetes mellitus
Risk Factors
Absorbable Implants
Clinical endpoint
030212 general & internal medicine
Myocardial infarction
Drug-eluting stents
Original Investigation
Clinical Trials as Topic
Hazard ratio
Middle Aged
Treatment Outcome
Bioresorbable scaffolds
Female
Cardiology and Cardiovascular Medicine
medicine.drug
Device thrombosis
Diabetes mellitu
medicine.medical_specialty
Device thrombosi
Prosthesis Design
Risk Assessment
03 medical and health sciences
Internal medicine
medicine
Humans
Everolimus
Aged
business.industry
Cardiovascular Agents
medicine.disease
Clinical trial
lcsh:RC666-701
Drug-eluting stent
business
Mace
Zdroj: Cardiovascular diabetology, 19(1):165. BioMed Central
Cardiovascular Diabetology, Vol 19, Iss 1, Pp 1-10 (2020)
Cardiovascular Diabetology
ISSN: 1475-2840
Popis: 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.
Databáze: OpenAIRE
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