Key result
Cre8 polymer-free amphilimus-eluting stents show favorable angiographic and clinical outcomes with potential benefits in diabetes.
Why the study?
Polymer-free drug-eluting stents like the Cre8 stent were conceived to overcome complications related to polymer persistence over time, such as local inflammatory reactions, delayed arterial healing, neoatherosclerosis, and ischemic adverse events.
The Cre8 polymer-free amphilimus-eluting stent shows favorable short- and medium-term outcomes and may offer specific benefits for patients with diabetes, though further randomized trials are needed.
Hypothesis-generating for polymer-free stents in diabetes; randomized trials needed before practice change.
Introduction: Polymer-free drug-eluting stents are designed with stent surface modifications and drug-matrix formulations in order to release antiproliferative agents without the need of a polymer coating. Polymer-free technologies have the potential to overcome complications due to polymer persistence over time, such as local inflammatory reactions, delayed arterial healing, neoatherosclerosis, and subsequent ischemic adverse events.Areas covered: The Cre8 polymer-free amphilimus-eluting stent received CE mark in 2011 and was conceived with the aim of addressing the safety and efficacy limitations of early generation drug-eluting stents based on permanent polymer coatings. Besides the absence of polymer, the main features of the Cre8 stent include the abluminal reservoirs, the passive carbon film coating, and the antiproliferative agent formulation based on sirolimus mixed with free-fatty acid chain – namely amphilimus. This review will focus on the Cre8 development, technical characteristics, preclinical evidence, clinical efficacy and safety, and future perspectives.Expert opinion: The Cre8 stent has shown favorable angiographic and clinical outcomes at short and medium-term follow-up. This technology might provide a benefit in patients with diabetes. Further randomized evidence is required to provide an adequate clinical evaluation of this promising technology in patients with and without diabetes.
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Pivato et al. (2020) conducted a review in Coronary artery disease. Cre8 amphilimus-eluting stent was evaluated. The Cre8 polymer-free amphilimus-eluting stent demonstrated favorable angiographic and clinical outcomes at short and medium-term follow-up, with potential benefits for patients with diabetes.
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