Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study

Abstract

Background 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. Methods The 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). Results Between 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. Conclusion EE-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

Clinical outcome of biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with diabetes

“…A bioresorbable scaffolds (BRS) may also be an alternative to metallic DES in diabetic patients. A recent study demonstrated the comparable midterm safety and efficacy outcomes of everolimus-eluting BRS in diabetic patients when historically compared with modern DES [41]. Although a concern for the incidence of thrombosis through the process of resorption still exists in the current BRS.…”

The 1-Year Safety and Efficacy Outcomes of Magmaris, Novel Magnesium Bioresorbable Vascular Scaffolds in Diabetes Mellitus Patients with Acute Coronary Syndrome

“…Therefore, the “4P technique“ (patient selection, proper sizing, pre-dilatation, and post-dilatation strategy) was proposed for appropriate stent optimization and was an essential part of the BRS implantation procedure in this study. This optimal implantation technique allowed us to partially reset the negative impact of diabetes on patients treated with BRS-ABSORB implantation [ 24 , 25 ]. However, the rate of peri-procedural complications remained higher than that in DES.…”

Real-world outcomes of different treatment strategies in patients with diabetes and three-vessel coronary disease: a mean follow-up 6.3 years study from China

“…It should be noted, the new generation of drug stents has thinner struts, and better biocompatible polymer coating and newer antiproliferative agents have reduced the rates of cardiovascular events in DM patients with PCI [ 31 ]. Recently, the everolimus-eluting bioresorbable scaffolds treatment in DM patients showed comparable midterm safety and efficacy outcomes when historically compared with modern DES [ 32 ]. In the future, with the development of PCI technology and the renewal of stents, perhaps the gap affected by PCI and CABG in the prognosis of patients with diabetes will be further narrowed.…”