Challenges in Patients with Diabetes: Improving Clinical Outcomes After Percutaneous Coronary Intervention Through EVOlving Stent Technology

Abstract

Patients with diabetes have poorer outcomes after percutaneous coronary intervention than patients without diabetes. The Cre8™ EVO drug-eluting stent (DES) has design features that aim to improve clinical outcomes in patients with diabetes. These include Abluminal Reservoir Technology - a proprietary polymer-free drug-release system consisting of reservoirs on the abluminal surface of the stent that control drug release and direct the drug exclusively towards the vessel wall - and the Amphilimus™ drug formulation, which enables enhanced drug-tissue permeation utilising fatty acid transport pathways. The latter is particularly advantageous in patients with diabetes, whose cell metabolism favours increased cellular uptake of fatty acid. Furthermore, evidence suggests that mTOR inhibitors (-limus drugs) utilised in conventional DES are less effective in diabetic cells. The new stent architecture provides high device deliverability and conformability, facilitating clinical use in complex disease patterns and high-risk lesion morphologies. Clinical evidence for the efficacy and safety of the Cre8™ DES in patients with diabetes has been demonstrated in a number of clinical trials and observational registries. These data are reviewed herein, along with an overview of on-going randomised trials.

The Impact of Diabetes Mellitus on Clinical Outcomes after Percutaneous Coronary Intervention with Different Stent Sizes

“…Diabetes can reduce fibrinolytic capacity, elevate the concentrations of hemostatic proteins, and induce endothelial dysfunction in terms of intimal hyperplasia and vascular inflammation. 18 , 19 The early onset and development of multifocal atherosclerotic plaques, especially in small-caliber coronary arteries, is a progressive process in diabetic patients. 20 Accordingly, it is plausible that diabetics are at an increased risk of coronary atherosclerosis, plaque burden, and accelerated maturation of multivessel CAD compared with nondiabetics.…”

Clinical outcomes after percutaneous coronary intervention in patients with and without history of diabetes mellitus with different stent size

“…DM distributes drastic effects through several adverse functions including reduction in brinolytic capacity, increasing concentrations of hemostatic proteins, and endothelial dysfunction such as intimal hyperplasia and vascular in ammation (12,13). Accordingly, early onset and progression of multifocal atherosclerotic plaques is facilitated in diabetic patients especially in small-caliber coronary arteries (14).…”

Intervencionismo coronario percutáneo en pacientes diabéticos: desafíos actuales y perspectivas futuras

“…Otra tecnología es el amphilimus, una formulación de sirolimus unida a ácidos grasos. Esta formulación tiene un diseño "inteligente", ya que al estar incrementada la actividad de los receptores de ácidos grasos en la membrana celular de las células diabéticas, se logra incrementar la dosis de sirolimus de forma diferencial a la célula no diabética que recibiría una dosis estándar 55 . Esta tecnología, aplicada en el stent Cre8Evo(Alvimedica), que es un strut sin polímero con arquitectura de celda abierta y strut fi no, ha demostrado efi cacia similar o superior a los actuales DES en un extenso programa de desarrollo clínico.…”