Abstract
BackgroundSeveral studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus.AimTo evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES.MethodsWe 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).ResultsA 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).ConclusionIn 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.
Highlights
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
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
Patient-level data were available from 499 diabetic patients; 150 patients (188 target lesions) were treated with EE-BRS and 249 (336 target lesions) with EES
Summary
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. Diabetes mellitus is a well-established predictor of adverse clinical and angiographic events following percutaneous coronary intervention (PCI) with metallic. Hommels et al Cardiovasc Diabetol (2020) 19:165 drug-eluting stents (DES) for obstructive coronary artery disease (CAD) [1,2,3,4,5,6]. Following PCI with stent implantation, the aforementioned mechanisms may be even aggravated by the permanent presence of the metallic vascular prosthesis that mechanically distorts the arterial geometry, delays vascular healing and constrains vascular response in the treated coronary segment [8,9,10]. The use of EE-BRS may allow for repeating PCI in the same target lesion without loss of lumen size due to the lifelong presence of multiple layers of metallic stents in the coronary vessel. Patients with diabetes mellitus, who are known to have an increased risk of repeated PCI and surgical treatment with CABG, may show a particular benefit from PCI with the utilization of EE-BRS
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