Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of
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ORIGINAL INVESTIGATION
Cardiovascular Diabetology Open Access
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 T. M. Hommels1 , R. S. Hermanides1, B. Berta1, E. Fabris2, G. De Luca3, E. H. Ploumen4, C. von Birgelen4 and E. Kedhi5*
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. Keywords: Bioresorbable scaffolds, Drug-eluting stents, Diabetes mellitus, Coronary artery disease, Percutaneous coronary intervention, Device thrombosis
*Correspondence: [email protected] 5 Department of Cardiology, Hôpital Erasme Université Libre de Bruxelles, Brussels, Belgium Full list of author information is available at the end of the article
Background Diabetes mellitus is a well-established predictor of adverse clinical and angiographic events following percutaneous coronary intervention (PCI) with metallic
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