The Cre8 amphilimus-eluting stent for the treatment of coronary artery disease: safety and efficacy profile.
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.
['Pivato|Carlo A|CA|https://orcid.org/0000-0001-5195-8815', 'Leone|Pier Pasquale|PP|https://orcid.org/0000-0002-0561-4760', 'Petriello|Gennaro|G|', 'Sanz-Sanchez|Jorge|J|', 'Chiarito|Mauro|M|https://orcid.org/0000-0002-9333-2658', 'Stefanini|Giulio G|GG|https://orcid.org/0000-0002-3558-6967']
D002986:Clinical Trials as Topic D003324:Coronary Artery Disease D054855:Drug-Eluting Stents D006801:Humans D011474:Prosthesis Design D020123:Sirolimus D016896:Treatment Outcome
cre8 coronary artery disease polymer-free drug-eluting stent Amphilimus percutaneous coronary intervention