Opinion - (2022) Volume 13, Issue 3
Among patients with acute coronary syndrome, diabetes mellitus in particular is a marker of poor clinical prognosis. Diabetics tend to have rapid progression of atherosclerosis, leading to an increased rate of multi vessel disease, which commonly requires recurrent revascularization. According to the current European Society of Cardiology (ESC) guidelines on myocardial revascularization [1], coronary artery bypass grafting (CABG) is preferred over percutaneous coronary intervention in diabetic patients. This recommendation is strictly related to a higher rate of short- and long-term adverse cardiovascular outcomes demonstrated after PCI. However, due to the aging and numerous comorbidities, PCI often remains the only available revascularization option. Many factors are postulated to play a role in the pathophysiological background of unfavourable results. Chronic vascular inflammation, endothelial dysfunction with increased oxidative stress, and increased platelet activation are cardiovascular responses to hyperglycaemia [2]. In addition, these chronic inflammatory responses are often exacerbated by the drug eluting stent [3] which can lead to delayed endothelialisation of stent and subsequently impaired vascular healing process.
To overcome these limitations, the bioresorbable materials have been widely used to develop new generations of scaffolds. These devices focus on suppressing the persistent inflammatory stimulus of the vascular wall by the stent surface. Recently, the new generation of sirolimus-eluting ioresorbable polymer DES Ultimaster (Terumo, Tokyo, Japan) has demonstrated a favourable 1-year safety and efficacy profile with concomitant rapid vascular wall healing and a high degree of strut coverage [4]. A thin, biodegradable gradient coating is a novel feature of the scaffold design. Thus, the bioresorbable DES technology refers not only to the polymer but also the entire stent platform. Bioresorbable vascular scaffolds (BRS) constitute a novel vessel-supporting technology that enables the vessel restoration without permanent presence of foreign material in the vessel wall. The initial enthusiasm for the first generation of BRS Absorb (Abbott, Chicago, United States) subsided following publication of the long-term results [5]. However, the second generation of magnesium BRS Magmaris (Biotronik, Berlin, Germany) has recently entered the market and has shown promising short-term outcomes [6].
The aim of this study is to investigate the performance of sirolimus-releasing bioresorbable polymer stents (Ultimaster) compared to bioresorbable magnesium scaffold (Magmaris) and to evaluate the theoretical advantages of this new technology in high-risk population patients with diabetes mellitus in the setting of ACS.
Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem.
The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM and the non- DM. The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up [6].
There were no significant differences between the diabetic and nondiabetic populations in primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year-follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. At the same time, the TLF occurred in the diabetic group in 4.1% Magmaris and 3.3% in the Ultimaster arm, respectively.
Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.
In our study both biodegradable polymer DES (Ultimaster) and Magnesium bioresorbable scaffold (Magmaris) revealed relative safety and efficiency features at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of instent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed in order to confirm fully our results.
None
The authors declare that there is no conflict of interest regarding the publication of this paper.
Indexed at, Google Scholar, Crossref
Indexed at, Google Scholar, Crossref
Indexed at, Google Scholar, Crossref
Indexed at, Google Scholar, Crossref
Indexed at, Google Scholar, Crossref
Citation: Rola P, Barycki M, Doroszko A, Szudrowicz M. Biodegradable Polymers and Bioresorbable Scaffold effects in Diabetic Population with NSTE-ACS. J Diabetes Metab, 2022, 13(3): 924.
Received: 02-Mar-2022, Manuscript No. jdm-22-16534; Editor assigned: 04-Mar-2022, Pre QC No. jdm-22-16534(PQ); Reviewed: 18-Mar-2022, QC No. jdm-22-16534; Revised: 21-Mar-2022, Manuscript No. jdm-22-16534(R); Published: 28-Mar-2022, DOI: 10.35248/2155-6156.1000924
Copyright: © 2022 Piotr Rola, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
