Alvimedica unveiled the details of the Diab8 study—the first diabetic drug-eluting stent randomised trial—during EuroPCR (22–25 May, Paris, France). Diab8 is a 55-centre, 3,040-patient randomised controlled trial that will compare the performance of Cre8 Evo (Alvimedica)—a polymer-free Amphilimus-eluting stent—with everolimus-eluting stents in the treatment of coronary artery disease in diabetic patients.
The aim of the study is to establish the superior efficacy of the Cre8 Evo compared with the current gold standard everolimus-eluting stent. Antonio Colombo, (IRCCS San Raffaele Hospital, Milan, Italy), principal investigator of the Diab8 trial, says: “People with diabetes have an increased risk of developing cardiovascular complications such as angina, coronary artery diseases, myocardial infarction and acute coronary syndrome. When undergoing percutaneous coronary intervention (PCI), patients with diabetes have poor outcomes compared to the general patient population since they are in fragile conditions, with a major risk of bleeding. Even though technological development applied to drug-eluting stents has enabled to reach great procedural success, there is still an urgent need to enhance long-term clinical outcomes after coronary revascularisation in patients with diabetes. Preliminary data regarding the efficacy of Cre8 in diabetic patients are very encouraging and through the Diab8 trial we hope we will be able to prove the efficacy of this innovative drug-eluting stents, as it could provide an important milestone for diabetics and their PCI treatment.”
Franco Vallana, Chief Scientific Officer Alvimedica comments: “The Cre8 Evo is a stent tailored to the needs of the diabetic population and it has been developed to ensure the same efficacy that current generation of drug-eluting stents provide to non-diabetic patients. Thanks to its unique features, it can improve clinical outcomes and provide added safety advantages in patients with diabetes compared to all other drug-eluting stents. We have the opportunity to contribute for a radical change in diabetic PCI clinical outcome and the Diab8 study is designed to establish the superior efficacy of the Cre8 Evo as the most innovative drug-eluting stents compared to the current golden standard.”
According to a press release, the new stent is designed to provide a controlled elution of the Amphilimus formulation through the Abluminal Reservoir Technology—a proprietary polymer-free drug-release system consisting of reservoirs on the stent’s outer surface that control and direct drug release exclusively towards the vessel wall, including complex coronary anatomies and pathologies like those of diabetics.
