Abstract
BackgroundPercutaneous 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.MethodsThe 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).ResultsBetween 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.ConclusionEE-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
Highlights
Diabetes mellitus (DM) is the most common metabolic disorder worldwide and its incidence and prevalence is increasing [1, 2]
target lesion revascularization (TLR) was defined as any repeat Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) of the target lesion performed for restenosis or other complication in which the treated segment was located 5 mm proximal and 5 mm distal to the scaffold
A revascularization was considered as ischemic-driven if: (i) angiography showed a diameter stenosis ≥ 50% on quantitative coronary angiography (QCA) and if a single criteria of the following occurred: a positive history of recurrent angina pectoris presumably related to the target vessel or objective signs of ischemia at rest or during exercise test related to the target vessel; (ii) abnormal results of any invasive functional diagnostic test; (iii) presence of a ruptured coronary atherosclerotic lesion on intracoronary imaging evaluation in the presence of clinical symptoms related to an acute coronary syndrome (ACS)
Summary
Diabetes mellitus (DM) is the most common metabolic disorder worldwide and its incidence and prevalence is increasing [1, 2]. Despite the advantages of novel drug-eluting stent (DES) and improved medical regiments in DM treatment, high rate of restenosis remains a challenge [11]. Large randomized trials persistently show a trend towards higher rates of major adverse cardiovascular events in DM patients treated with percutaneous coronary intervention (PCI) compared to coronary artery bypass grafting (CABG) [12,13,14]. PCI is still largely performed in this high-risk population especially in young patients where long-term CABG outcomes are unknown. 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
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